Generated by All in One SEO v5.0.0.1, this is an llms.txt file, used by LLMs to index the site. # Pharmetheus ## Sitemaps - [XML Sitemap](https://pharmetheus.com/sitemap.xml): Contains all public & indexable URLs for this website. ## News - [News](https://pharmetheus.com/news/) - Welcome to our corporate news page, covering topics such as publications and research, high-profile people joining our team and more. - [Karam Alali shares his experience of Uppsala Pharmacometric Summer School](https://pharmetheus.com/news/karam-alali-shares-his-experience-of-uppsala-pharmacometric-summer-school/) - The 2026 Uppsala Pharmacometrics Summer School (UPSS) is now open for applications. More than just a learning opportunity, UPSS offers participants the chance to connect with peers and gain practical skills in pharmacometrics. Karam Alali, a Ph.D. student and 2024 UPSS participant, attended the program with the support of a travel grant provided by Pharmetheus, which made his participation possible. - [Pharmetheus Board appoints Jonas Möller as new CEO](https://pharmetheus.com/news/pharmetheus-board-appoints-jonas-moller-as-new-ceo/) - Peter Milligan is retiring after seven successful years as CEO of Pharmetheus, and the board has appointed Jonas Möller as his successor. - [Lourdes Cucurull-Sanchez joins Pharmetheus as Scientific Lead for the Quantative Systems Pharmacology (QSP) platform](https://pharmetheus.com/news/lourdes-cucurull-sanchez-joins-pharmetheus-as-scientific-lead-for-the-quantative-systems-pharmacology-qsp-platform/) - She brings extensive experience from several positions from large companies within drug development, and has made strong scientific contributions through her work within clinical pharmacology. The addition strengthens the company’s focus on QSP, ensuring continued innovation and latest expertise. - [Pharmetheus evolves its organization to further promote innovation and growth with additions to its leadership team](https://pharmetheus.com/news/pharmetheus-evolves-organization/) - Pharmetheus announces an evolved organizational structure with additions in the leadership team, and expands business development to further promote innovation and growth. - [CAR-T cell therapy is part of the next generation of immuno-oncology treatment](https://pharmetheus.com/news/car-t-cell-therapy-is-part-of-the-next-generation-of-immuno-oncology-treatment/) - It was Anna's passion and expertise in novel therapeutic modalities such as CAR-T cells that led her to her current position at Pharmetheus. She can be considered one of the few experts in the field of CAR-T cell modeling. Her review paper, "Model-informed drug development of autologous CAR-T cell therapy: Strategies to optimize CAR-T cell exposure leveraging cell kinetic/dynamic modeling," was one of the most downloaded papers last year. - [Extrapolating clinical efficacy in rare diseases: Bayesian modeling of nintedanib for childhood interstitial lung disease](https://pharmetheus.com/news/extrapolating-clinical-efficacy-in-rare-diseases-bayesian-modeling-of-nintedanib-for-childhood-interstitial-lung-disease/) - Two recent publications in CPT: Pharmacometrics & Systems Pharmacology—resulting from a strategic collaboration between Boehringer Ingelheim and Pharmetheus—exemplify how Model-Informed Drug Development (MIDD) can successfully extrapolate results from approved adult indications to pediatric patients suffering from rare diseases. Nintedanib is a well-established standard of care for adults with several chronic fibrosing interstitial lung diseases (ILDs), - [Education for empowerment: Online training in Clinical Pharmacology and Pharmacometrics in French](https://pharmetheus.com/news/csr-pharmetheus-pharmacometrics-africa/) - In a global landscape where language can serve as a barrier to knowledge acquisition, the need for scientific learning material in French is pivotal in many African countries. Pharmetheus' consultants, primarily those who contributed to the French translation of Pharmacometrics Africa’s Pharmacometrics Self-paced online course, feature as guest speakers. - [Pharmetheus passes 100 employees and moves to new office in central Uppsala](https://pharmetheus.com/news/100-employees-and-office-relocation/) - Pharmetheus AB has reached a capacity milestone with more than one hundred persons on the team, and relocates to new headquarters next to Uppsala Central Station, a strategic move to accommodate the growing need of its services, driving the expansion of the team. - [Sign up to our satellite meetings at PAGE 2025 - Early bird registration open](https://pharmetheus.com/news/sign-up-to-our-satellite-meetings-at-page-2025-early-bird-registration-open/) - Pharmetheus will be hosting satellite meetings at PAGE 2025 in Thessaloniki, Greece. These sessions will cover topics such as MIDD in regulatory interactions, physiologically-based translational modeling, and (R)TTE analysis. Sign up early to secure your spot and connect with our experts in a collaborative setting. - [Pharmetheus appoints Regulatory Affairs Consultant](https://pharmetheus.com/news/pharmetheus-appoints-regulatory-affairs-consultant/) - With an increasing need to optimize and de-risk the drug development process, expertise in regulatory affairs is of the essence. Pharmetheus is growing its capabilities within the field to support clients in increasing the probability of a successful drug development program. - [Pharmetheus awarded Di Gasell for the 5th time](https://pharmetheus.com/news/pharmetheus-awarded-di-gasell-for-the-5th-time/) - The Di Gasell-prize is awarded annually by Sweden's leading daily financial newspaper, Dagens industri, to recognize the fastest-growing enterprises in Sweden. It aims to celebrate companies that pioneer innovation, challenge industries, contribute to economic growth, and create employment opportunities. - [Adaptability and aptitude for learning — essential traits for future pharmacometricians](https://pharmetheus.com/news/training-pharmacometric-modelers/) - Want to thrive in model-informed drug development? Discover why adaptability and continuous learning are must-have skills for today’s pharmacometrics students. - [Employee story: “Values are not just external slogans, they need to be lived”](https://pharmetheus.com/news/values-are-not-just-external-slogans-they-need-to-be-lived/) - Ida Neldemo reflects on her journey as a MIDD consultant at Pharmetheus and how integrity shapes every client interaction. - [Attend the third annual Educational Pharmacometrics Summer Symposium in connection to PAGE 2025](https://pharmetheus.com/news/attend-the-third-annual-educational-pharmacometrics-summer-symposium-epss-in-connection-to-page-2025/) - Don't miss the chance to attend the fourth annual Educational Pharmacometrics Summer Symposium (EPSS) on June 3, 2025 the Makedonia Palace Hotel, Thessaloniki, Greece. A free symposium including presentations from experts and professionals in the pharmacometrics field, accompanied by case examples presented by student attendees to help you get a wide overview of this exciting - [Inspiring and empowering students to get into pharmacometrics](https://pharmetheus.com/news/inspiring-students-to-get-into-pharmacometrics/) - This year’s Educational Pharmacometrics Summer Symposium (EPSS) is taking place in conjunction with the PAGE 2023 meeting in A Coruña, Spain. The EPSS is a satellite event, mainly intended for Master’s and PhD students interested in learning more about pharmacometrics. - [Pharmetheus strengthens board of directors with key appointments](https://pharmetheus.com/news/pharmetheus-board-appointments-april2024/) - Pharmetheus, a leading company in biosimulation and biotech, is pleased to announce the appointment of two esteemed professionals to its Board of Directors, further enhancing the company's strategic vision and expertise. These appointments, effective immediately, represent an important step forward in Pharmetheus's commitment to innovation, growth, and excellence. - [No giveaways for Pharmetheus at PAGE - instead we pay it forward](https://pharmetheus.com/news/no-giveaways-for-pharmetheus-at-page/) - There will be no giveaways at the exhibition booth when Pharmetheus participates in PAGE 2023 . Instead, Pharmetheus donates its entire giveaway fund to selected causes resonating well with the company’s CSR goals, and challenges others to do the same. - [New Chair of the Board](https://pharmetheus.com/news/new-chairman-of-the-board/) - Pharmetheus welcomes Magnus Forsbrand as new chair of the Board. His experiences as CEO, developing business, and from serving as board member for high-growth companies will further guide Pharmetheus on its exciting journey. Magnus Forsbrand has gotten to know Pharmetheus during the past year. His ambitions for the company are clear: "Pharmetheus will keep the - [Opportunities to grow professionally – and to find friends for life](https://pharmetheus.com/news/its-a-chance-encounter-that-i-stumbled-upon-pharmacometrics-and-i-was-very-lucky/) - Read our story about Dr. Qing Xi, a testament to the international spirit at Pharmetheus. She is originally from Malaysia but has studied both in the UK and in New Zealand. She is now based at Pharmetheus’ head office in Uppsala – but makes frequent trips across the world. - [Pharmetheus workshops at ACoP 2023. Read more and sign up here.](https://pharmetheus.com/news/pharmetheus-workshops-at-acop-2023-read-more-and-sign-up-here/) - [Paving the way for increased use of pharmacometrics and Model-Informed-Drug-Development at University of Latvia](https://pharmetheus.com/news/paving-the-way-for-increased-use-of-pharmacometrics-and-model-informed-drug-development-at-university-of-latvia/) - As part of a CSR initiative, Svetlana Freiberga, Data Programmer at Pharmetheus, gave three seminars at University of Latvia on Model-Informed-Drug-Development (MIDD) and pharmacometrics, also covering aspects of data programming. - [Prof. France Mentré, Ph.D., new advisor at Pharmetheus](https://pharmetheus.com/news/prof-france-mentre-ph-d-new-advisor-at-pharmetheus/) - We are thrilled and proud to announce Prof. France Mentré, Ph.D. as a collaborator to Pharmetheus in the role as a Scientific Advisor! - [Welcome Agneta Lehane!](https://pharmetheus.com/news/welcome-agneta-lehane/) - We are happy to announce that Agneta Lehane has joined the Pharmetheus team. Agneta will be working as an Administrative Assistant, mainly supporting the communication & marketing activities. She brings experience in administration, sales, marketing and educational events. She has also worked with social media and the web. Agneta is based in Sweden and is - [Welcome Henrik Beckman!](https://pharmetheus.com/news/welcome-henrik-beckman/) - We warmly welcome Henrik Beckman, IT Security Manager, to Pharmetheus. Henrik has experience as an Chief Security Officer and Head of IT Operations & Technology, and has expertise within information security, protective security and cyber security. Based in Sweden, Henrik will be working from our Uppsala Office. Great to have you with us, Henrik! - [Welcome Nina Englund!](https://pharmetheus.com/news/welcome-nina-englund/) - We are happy to have Nina Englund on board as Event Coordinator. Her experience includes planning, organizing and supporting events; global conferences, meetings and workshops. She has also worked with other areas of marketing, such as web administration and customer trainings. Nina is based in Sweden and is working from our Uppsala office. Welcome to - [Welcome Martina Lundgren!](https://pharmetheus.com/news/welcome-martina-lundgren/) - We are thrilled to have Martina Lundgren joining Pharmetheus as Communication & Marketing Manager. Her experience from marketing and communication from various industries and organizations will be put into good use at Pharmetheus. Martina is based in Sweden, working from our Uppsala office. Welcome to the team, Martina! - [Welcome Alexis Boucharin!](https://pharmetheus.com/news/welcome-alexis-boucharin/) - We are happy to welcome Alexis Boucharin, joining Pharmetheus as System Development Team Leader! His experience includes leading software development teams in a regulated environment, product development, project management and agile methodologies. Alexis is based in Sweden and is working from our Uppsala office. Welcome to Pharmetheus! - [Welcome Kamunkhwala Gausi!](https://pharmetheus.com/news/welcome-kamunkhwala-gausi/) - A warm welcome to Kamunkhwala Gausi, joining Pharmetheus as an Associate Consultant! Her experience includes utilizing pharmacometrics modeling to inform and improve the treatment of infectious diseases, with a particular focus on neglected populations, such as pregnant and breastfeeding women. Kamunkhwala is based in Sweden and is working from our Uppsala office. Welcome to Pharmetheus!. - [Pharmetheus' fit-for-purpose approach to meeting client needs](https://pharmetheus.com/news/pharmetheus-fit-for-purpose-approach-to-meeting-clientneeds/) - Pharmetheus started by offering pharmacometrics services that use mathematical and statistical models based on data in all phases of the drug development process. We talked with Elodie Plan and Marylore Chenel, both Principal Consultants and Team Leaders at Pharmetheus, to learn more about how the company’s offering has developed over time and how the company keeps up with state of the art methodologies. - [A new visual identity as we enter our second decade](https://pharmetheus.com/news/a-new-visual-identity-as-we-enter-our-second-decade/) - The new visual identity includes a new logo, updated colors of our reports, and marketing and communication materials. We go live with a completely new website, with a new graphic design, and new content showcasing our services and solutions in a more informative way. - [Sign up to Educational Pharmacometrics Summer Symposium in A Coruña](https://pharmetheus.com/news/sign-up-to-educational-pharmacometrics-summer-symposium-in-a-coruna/) - Boehringer Ingelheim, Pharmetheus and University of Navarra are supporting the second Educational Pharmacometrics Summer Symposium, which will take place at the University of A Coruña, on the 27 June 2023. The participation is free of charge and you can register by following this link (open until 31 May 2023). Based on last year’s very positive feedback, register early to - [Pharmetheus attending the ASCPT 2023 Annual Meeting](https://pharmetheus.com/news/pharmetheus-attending-the-ascpt-2023-annual-meeting/) - Pharmetheus is delighted to attend the American Society for Clinical Pharmacology & Therapeutics Annual Meeting in Atlanta this week. If you are interested in discussing benefits of implementing a model-informed drug development strategy or Pharmetheus’ services, don’t hesitate to reach out to our colleagues Anna Mc Laughlin, Dr. rer.nat., Associate Consultant, and Sofia Friberg Hietala, - [Increasing MIDD awareness: presentations in Pakistani Universities](https://pharmetheus.com/news/increasing-midd-awareness-presentations-in-pakistani-universities/) - At Pharmetheus, we believe in the power of quality education and are excited to contribute in spreading the interest and engagement in the growing field of pharmacometrics and model-informed drug development. We are proud that in January, our colleague Sami Ullah, PhD, had a Pakistan pharmacometrics awareness campaign, and presented the introductory pharmacometrics lecture to - [Workshop on Forest Plots in connection to PAGE 2023](https://pharmetheus.com/news/workshop-on-forest-plots-in-connection-to-page-2023/) - Are you going to the PAGE 2023 meeting in A Coruña, Spain? Interested in communicating the impact of covariates in pharmacometrics models? Join Pharmetheus’ one-day workshop, focusing on implementation and interpretation of Forest Plots, a pre-conference satellite meeting to PAGE. Forest plots, as recommended by the FDA in their latest Population PK guidance, is becoming - [Workshop on PBPK-PD/QSP modeling with the OSPSuite (PK-Sim®, MoBi®) in connection to PAGE 2023](https://pharmetheus.com/news/workshop-on-pbpk-pd-qsp-modeling-with-the-ospsuite-pk-sim-mobi-in-connection-to-page-2023/) - Are you going to the PAGE 2023 meeting in A Coruña, Spain? Do you want to advance your knowledge in PBPK-QSP? Join Pharmetheus’ pre-conference two-day workshop focusing on how to leverage the open source platforms PK-Sim® and MoBi®. With this workshop you will learn to develop whole-body physiologically based pharmacokinetic (WB-PBPK) models in PK-Sim®, using - [Uppsala Pharmacometrics Summer School: registration open](https://pharmetheus.com/news/uppsala-pharmacometrics-summer-school-registration-open/) - If you are a Ph.D. student within the field of pharmacometrics eager to sharpen your knowledge, we want to bring to your attention that our colleagues at Uppsala University will be conducting the 11th Uppsala Pharmacometrics Summer School (UPSS) this summer. This is a good occasion to discuss some of our favorite topics: covariate model - [Open positions in Systems Development](https://pharmetheus.com/news/open-positions-in-systems-development/) - We are looking for two new team members for our System Development Team! Pharmetheus is a motivated, dedicated, and growing group of 80+ people, currently undergoing exciting developments and we are looking to expand our capacities and capabilities in our tools and process development. Open position: Systems Developer Team Leader.Read more and apply here Open - [Opening event: New office in Paris](https://pharmetheus.com/news/opening-event-new-office-in-paris/) - It was a great pleasure to welcome so many members of the French scientific community for a mini-conference & social event, held in connection with the opening of our new Pharmetheus office in Paris, France. Marylore Chenel, Principal Consultant & Team Leader, hosted the event on behalf of Pharmetheus inviting our French collaborators and friends - [Welcome Maria Dahl Blomberg!](https://pharmetheus.com/news/welcome-maria-dahl-blomberg/) - Maria Dahl Blomberg will be working as an Administrative Assistant and responsible for our client project archive at Pharmetheus. Maria has extensive experience as an Executive Assistant and from administrative positions. Maria will be working from our Uppsala office in Sweden. We are very excited to have you on board!. - [Welcome Gianluca Selvaggio!](https://pharmetheus.com/news/welcome-gianluca-selvaggio/) - Pharmetheus is proud to announce that we recently welcomed Gianluca Selvaggio to our team of consultants! Gianluca’s experience includes QSP modeling over different therapeutic areas, integrated with a strong knowledge of the underlying biological processes and the experimental setup to measure them. Gianluca brings QSP expertise to Pharmetheus and strengthens our PBPK-QSP team. He will - [Welcome Christina Pentafragka!](https://pharmetheus.com/news/welcome-christina-pentafragka/) - Meet our new Quality Control and Medical Writing Consultant! We are delighted to have Christina Pentafragka join Pharmetheus. Christina’s experience includes Clinical Research, Biopharmaceutics, and Pharmacokinetics. Based in Greece, Christina will work from her home office in Athens. Welcome Christina! - [New Pharmetheus office in Paris, France](https://pharmetheus.com/news/new-pharmetheus-office-in-paris-france/) - We are excited to announce the opening of our new office in Paris, France, located in the Montparnasse area. As Marylore Chenel, Principal Consultant & Team Leader at Pharmetheus commented: "I am very glad that our Paris-based consultants will now have a shared working space. France has a strong network of pharmacometricians, and having a physical ## Pages - [Home](https://pharmetheus.com/) - Diversified Life Sciences consultancy partner at the forefront of the application of quantitative approaches to drug research, development, and usage. - [Workshop at ACoP 2026 – (R)TTE analysis: MIDD applications, concept, methodology and NONMEM hands-on](https://pharmetheus.com/events/acop/workshop-tte-rtte-modeling-nonmem-2026/) - Sign up now to secure your spot The workshop’s objective is to provide a good understanding of time to event (TTE) and repeated TTE (RTTE) modeling in NONMEM, in theory and practice, by listening to and discussing with leaders from industry and academia. Pharmacometricians with no, or limited, experience of TTE/RTTE modeling, and students. The - [Events](https://pharmetheus.com/events/) - We believe in building a strong community and sharing knowledge. That's why we host a variety of events, workshops, and training sessions throughout the year. We also attend numerous conferences, and we'd love to connect with you there! - [Scientific advisors](https://pharmetheus.com/about-us/scientific-advisors/) - Our Scientific advisors include professors at academic centers of excellence. We have established longstanding collaborations with prestigious universities such as Uppsala University, Université de Paris, and University of Cape Town. Through our advisors, our clients and consultants access a worldwide network of expertise. - [Let’s connect: Pharmetheus’ 2026 conference calendar](https://pharmetheus.com/events/pharmacology-conference-calendar/) - Meet Pharmetheus in 2026 We look forward to participating in several pharmacology conferences and industry meetings throughout 2026. For us, these events are a valuable opportunity to learn from our peers and contribute to the field's collective knowledge. Members of our team will contribute to the scientific program at various locations—sharing our recent work and - [Pharmetheus at AAPS PharmSci 2026](https://pharmetheus.com/events/pharmetheus-at-aaps-pharmsci-2026/) - Join us at the 51st ESMO Congress, October 23–27, 2026, in Madrid, Spain. This premier event organized by the European Society for Medical Oncology (ESMO) brings together global oncology professionals to discuss groundbreaking cancer research, translating science into survival to improve patient care and advance oncology practice worldwide. - [Mission, vision & values](https://pharmetheus.com/about-us/mission-vision-values/) - Our mission, vision and values • Pharmetheus - [Workshop: Learn and apply TTE and RTTE modeling with a focus on NONMEM](https://pharmetheus.com/events/pharmetheus-at-page-2025/workshop-page-2025-tte-rtte-modeling-nonmem/) - Workshop in connection to PAGE 2025, Thessaloniki, Greece This one-and-a-half-day workshop provides a comprehensive introduction to time-to-event (TTE) and repeated TTE (RTTE) modeling in NONMEM, covering both theoretical concepts and practical applications. Audience The workshop is designed for students and pharmacometricians with little to no prior experience in TTE/RTTE modeling. Learning objective Participants engage with - [Pharmetheus at PAGE 2026](https://pharmetheus.com/events/pharmetheus-at-page/) - Note: This event has passed. For upcoming events, please visit the Events page. Scientific contributions Wed, Jun 3, 2026, 10:30 – 12:00 I-072: Food effect prediction of high permeability/low solubility, formulated as an amorphous solid dispersion (ASD) using an open systems pharmacology (OSP) PBBM approach Vrenken P, Lambert M, Mezzalana E, Eriksson J, Fouliard S, - [Pharmetheus at the 1st International PBPK Conference](https://pharmetheus.com/events/pharmetheus-at-int-pbpk-conference/) - Note: This event has passed. For upcoming events, please visit the Events page. Explore our posters and scientific sessions at International PBPK Conference 2026. - [PAGE 2026 workshop: Mastering covariate modeling - hands-on with the Full Random Effects Model (FREM) approach](https://pharmetheus.com/events/pharmetheus-at-page/2026-june-frem-page-workshop/) - Join this workshop at ACoP 2025 for hands-on training in applying FREM effectively for robust decision-making in pharmacometrics. - [Leadership & Board of Directors](https://pharmetheus.com/about-us/leadership/) - The Pharmetheus leadership team combines a diverse range of expertise across drug development, clinical pharmacology, and global business strategy. Their collective experience and strategic vision ensures that Pharmetheus delivers market-leading solutions in model-informed drug development (MIDD) for our partners worldwide. - [PAGE 2026 workshop: PBPK & PBBM – linking biopharmaceutics to clinical performance with OSP suite ](https://pharmetheus.com/events/pharmetheus-at-page/2026-june-pbpkpbbm-page-workshop/) - Join this workshop at ACoP 2025 for hands-on training in applying FREM effectively for robust decision-making in pharmacometrics. - [A practical checklist for navigating CRO partnerships](https://pharmetheus.com/perspective/a-practical-checklist-for-navigating-cro-partnerships/) - When integrating an existing Quantitative Systems Pharmacology (QSP) model into your drug development program, the "context of use" is everything. Not all models are created equal, and understanding the data foundation of a CRO or vendor’s existing model is essential to identify and mitigate its limitations and associated risks. This checklist provides a framework of - [Pharmetheus at GMP 2026 Symposium](https://pharmetheus.com/events/gmp/) - Join us at the 38th GMP Symposium, happening as a joint meeting October 5–7, 2026, at the Vienna House by Wyndham Diplomat Hotel in Prague, Czech Republic. Organized by the Groupe de Métabolisme et Pharmacocinétique (GMP) in collaboration with the DMDG and the Swedish Pharmaceutical Society (SPS), this event brings together international scientists to explore the frontiers of drug metabolism, DMPK, and PK/PD modeling to accelerate translation from discovery to development. - [Pharmetheus at ESMO 2026](https://pharmetheus.com/events/esmo/) - Join us at the 51st ESMO Congress, October 23–27, 2026, in Madrid, Spain. This premier event organized by the European Society for Medical Oncology (ESMO) brings together global oncology professionals to discuss groundbreaking cancer research, translating science into survival to improve patient care and advance oncology practice worldwide. - [Pharmetheus at OSP Community Conference](https://pharmetheus.com/events/osp-community-conference/) - Join us at Open Systems Pharmacology (OSP) 2026, a community-driven initiative that provides transparent, open-source solutions for model-informed drug development (MIDD). This annual conference gathers over 100 attendees from more than 40 institutions to share practical applications of the OSP Suite (PK-Sim and MoBi) across research, safety, and regulatory science. - [Pharmetheus at ACoP 2026](https://pharmetheus.com/events/acop/) - Learning opportunities at ACoP 2026 - [Join Pharmetheus](https://pharmetheus.com/careers/open-positions/) - NoteDue to GDPR and privacy regulations, we do not accept job applications via email. Please use the application forms provided above. Applications sent directly to our general contact email will not be processed. - [How can we help you?](https://pharmetheus.com/contact-us/) - We believe that clear communication is the first step toward solving complex challenges, whether you are looking to optimize a drug development program, join our global team, or simply learn more about quantitative approaches. We assist our clients with everything from strategic planning to analysis and regulatory support in model-informed drug development, pharmacometrics, PBPK/PBBM, and - [Workshop: (R)TTE analysis - MIDD applications, concept, methodology and NONMEM hands-on](https://pharmetheus.com/events/2026-october-pharmacometrics-acop-workshop/) - The workshop’s objective is to provide a good understanding of time to event (TTE) and repeated TTE (RTTE) modeling in NONMEM, in theory and practice, by listening to and discussing with renowned workshop leaders from both industry and academia. This workshop provides: The motivation for running survival analyses from a model-informed drug development perspective, An - [Poster: Model-Based Bioequivalence (MBBE) methods open new doors for generics](https://pharmetheus.com/mbbe-open-new-doors-for-generics/) - Contact: henrik.nyberg@pharmetheus.com Henrik Bjugård Nyberg a, Andrew C Hooker a, b, Martin Bergstrand a, Marylore Chenel a,E Niclas Jonsson aa Pharmetheus AB, Sweden,b Uppsala University, Sweden Traditional bioequivalence (BE) via Non-Compartmental Analysis (NCA) has low power and requires prohibitive sample sizes for several classes of drugs, creating barriers to affordable generics. Model-Based Bioequivalence (MBBE) methods - [Time to register for the Educational Pharmacometrics Summer Symposium 2026](https://pharmetheus.com/events/epss-page-2026/) - Don't miss the chance to attend the fourth annual EPSS in connection to PAGE 2026 in Dubrovnik, Croatia! - [Reducing inequality](https://pharmetheus.com/about-us/corporate-social-responsibility/reducing-inequality/) - For nations to flourish, equality and prosperity must be available to everyone — regardless of gender, race, religious beliefs or, economic status. Pharmetheus works actively towards reducing inequality by providing a workplace with equal opportunities for all employees and job candidates. At present, we operate in more than 10 countries. A multicultural perspective is embedded - [Quality education](https://pharmetheus.com/about-us/corporate-social-responsibility/quality-education/) - Education is the key to prosperity and opens a world of opportunities, making it possible for each of us to contribute to a progressive, healthy society. Learning benefits every human being and should be accessible to all. At Pharmetheus, we demonstrate our dedication to quality education by producing the highest level of education and leading - [Protecting the environment](https://pharmetheus.com/about-us/corporate-social-responsibility/protecting-the-environment/) - Climate change is a real and undeniable threat to our entire civilization. The effects are already visible and will be catastrophic unless we act now. Through education, innovation, and adherence to our climate commitments, we can make the necessary changes to protect the planet. These changes also provide huge opportunities to modernize our infrastructure which - ["We are dedicated to what we do and empower each other to advance the field"](https://pharmetheus.com/careers/employee-stories/jurij-aguiar-zdovc/) - Considering a career at Pharmetheus? Read Jurij's story – learn about our unique company culture, scientific opportunities, and professional growth. - [“Values are not just external slogans, they need to be lived”](https://pharmetheus.com/careers/employee-stories/ida-neldemo/) - Ida Neldemo's work involves hands-on modeling and report writing, using client data to develop models that help determine optimal medication doses. Her role is not just technical; it also involves upholding the highest standards of integrity. Once, when a client was hesitant to submit an abstract for a promising medication due to financial concerns, Ida - ["I'm not just creating a model, I’m trying to save lives”](https://pharmetheus.com/careers/employee-stories/jurgen-langenhorst/) - Jurgen Langenhorst has a LinkedIn profile picture where he is standing on top of a snow covered mountain. He loves the mountains, although he admits that it’s a bit weird as he lives in the Netherlands which consists mostly of flat low lying plains. He explains that the picture was taken some years ago in - ["My colleagues are thought leaders in the industry and I wanted to work with the best"](https://pharmetheus.com/careers/employee-stories/andrea-henrich/) - Considering a career at Pharmetheus? Read Andrea Henrich's story – learn about our unique company culture, scientific opportunities, and professional growth. - ["It's a chance encounter that I stumbled upon pharmacometrics, and I was very lucky"](https://pharmetheus.com/careers/employee-stories/qing-xi-ooi/) - Considering a career at Pharmetheus? Read Qing Xi's story – learn about our unique company culture, scientific opportunities, and professional growth. - ["Sharing with colleagues is why I love working here"](https://pharmetheus.com/careers/employee-stories/sophie-peigne/) - What do you do at Pharmetheus? As an MIDD consultant, I support clients with expert and strategic advice in pharmacometrics for compounds in all development phases, from non-clinical to clinical phases and until submission dossier. I also perform hands-on pharmacometrics analyses and related work with a focus on quality. As a Project Leader, I make - [Registration and purchase terms, workshops and events](https://pharmetheus.com/registration-and-purchase-terms-workshops/) - Payment of the registration fee (and any applicable VAT) for the Workshop must be made in full no later than the day before the workshop occurs. The invoice will be issued through PayPal and can be paid by credit card. (See payment instructions in the confirmation email.) We cannot guarantee your slot at the Workshop - [On-demand insights: model-informed bioequivalence & biosimilarity](https://pharmetheus.com/events/model-based-bioequivalence-biosimilarity-webinar/) - This webinar series provides an introduction to model-informed bioequivalence, including its potential and limitations. You’ll gain an understanding of the techniques physiologically-based biopharmaceutics modeling (PBBM) for virtual bioequivalence and non-linear mixed-effects modeling (NLME) for model-based bioequivalence (MBBE), and how they are transforming approaches to drug development and regulatory submissions. Introduction to Model-Informed Bioequivalence and Biosimilarity - [Pharmetheus at ASCPT](https://pharmetheus.com/events/pharmetheus-at-ascpt/) - We will be attending ASCPT 2026 in Denver, March 4–6. Visit our poster session or join our MIDD session to discuss the latest in Model-Informed Drug Development. - [Workshop: PBPK modeling for DDI with OSP suite version 12](https://pharmetheus.com/events/pharmetheus-at-int-pbpk-conference/2026-april-ddi-pbpkc-workshop/) - Increase your capabilities to support decision making in drug development with PBPK. Join our workshop at the 1st International PBPK Conference, April 21 2026. - [Workshop: PK-Sim introduction - a crash course to get you started with OSP suite version 12](https://pharmetheus.com/events/pharmetheus-at-int-pbpk-conference/2026-april-pk-sim-intro-pkpbc-workshop/) - Increase your capabilities to support decision making in drug development with PBPK. Join our workshop at the 1st International PBPK Conference, April 21 2026. - [Practical takes on the ICH M15 guidelines: MIDD evidence in regulatory interactions](https://pharmetheus.com/events/pharmetheus-at-ascpt/ich-m15-guideline-learning-lab/) - Lunch & learn - ASCPT Friday March 6, 202612.15 PM -1.15 PM Aurora Ballroom D In this Lunch & learn event, Martin Bergstrand and Emma Hansson will provide insights into the evolving application of MIDD in regulatory settings. The session will cover: Practical considerations for putting the ICH M15 guideline into action Strategies for planning, generating, and presenting - [Careers](https://pharmetheus.com/careers/) - Open positions - [Employee stories](https://pharmetheus.com/careers/employee-stories/) - If you want to know more about what it is like to be working with us, there's no better way than hearing it from future colleagues. Their stories are their own, but they share common ground - they are dedicated, collaborative and perform their work with integrity. They are our people. - [Speed advising for students](https://pharmetheus.com/events/speed-advising/) - Kamunkhwala Gausi, Ph.D.: Said by participant Alam Shah, Postgraduate researcher at China Pharmaceutical University: "I am sincerely thankful to the team at Pharmetheus for their time, expertise and thoughtful discussion. Looking forward to applying these insights in my ongoing research and future collaborations!" Behind the initiative is Kamunkhwala Gausi, Ph.D., with support from Bastian Kister, - [Working with us](https://pharmetheus.com/careers/working-with-us/) - As a member of our team, you will bridge the gap between academic excellence and industrial application. We empower our employees to be thought leaders, providing the autonomy and the tools needed to solve the industry’s most complex pharmacometric challenges. Collaboration is key for us, both internally and externally, we help each other, and it - [History of Pharmetheus](https://pharmetheus.com/about-us/history/) - Our company name draws inspiration from the titan Prometheus in Greek mythology. Prometheus, known for his intelligence and as a champion of mankind, embodies the values we strive for. Our company was officially founded in 2012, by a like-minded group of expert consultants, pharmaceutical industry leaders, and academic researchers at Uppsala University. They joined forces - [Utrecht - Directions](https://pharmetheus.com/contact-us/utrecht-directions/) - [Paris - Directions](https://pharmetheus.com/contact-us/paris-directions/) - [Uppsala - Directions](https://pharmetheus.com/contact-us/uppsala-directions/) - [General application](https://pharmetheus.com/careers/general-application/) - Are you interested in a career at Pharmetheus, and have qualifications you believe are a good match - but can't find a suitable open position? Fill out the general interest form and we will get in touch! - [Science and Services](https://pharmetheus.com/science-and-services/) - Pharmetheus specializes in quantitative approaches to drug research, development, and usage. We offer regulatory-compliant solutions that ensure effective use of data allowing your team to more accurately characterize the potential drug effects and make confident decisions with sufficient precision.To improve human health, we explore data, create models, and collaborate with our clients, colleagues, and the - [About us](https://pharmetheus.com/about-us/) - Diversified Life Sciences consultancy partner at the forefront of the application of quantitative approaches to drug research, development, and usage. We operate in the area of biosimulation and biotech, using software to describe biological processes. - [Social impact (CSR)](https://pharmetheus.com/about-us/corporate-social-responsibility/) - Pharmetheus’ Corporate Social Responsibility (CSR) promise is to become an ever more sustainable and responsible company. As with all initiatives within Pharmetheus, our CSR strategy stems directly from our vision and core values. To ensure we are in line with other global responsibility initiatives we have also aligned ours with the UN Sustainable Development Goals. - [Pharmetheus at PKUK](https://pharmetheus.com/events/pharmetheus-at-pkuk/) - We will be attending PKUK 2025 at the University of Warwick from November 26-28. We look forward to connecting with you at the conference. If you are interested in learning more about Pharmetheus or wish to discuss our specific pharmacometrics and consulting services, we invite you to schedule a meeting with us. Please use the form on this page to book a dedicated time with our team. - [Stockholm Uppsala Pharmacometrics (SUP) – Fall meeting 6th of November](https://pharmetheus.com/events/sup-meeting/) - Learn more about Stockholm Uppsala Pharmacometrics at the SUP meetings website This meetings theme: AI – Artificial Intelligence Presentations: From genes to patients: Mavatar Discovery — AI-powered research platform for unbiased biological insights,Danuta Gawe, Mavatar Accelerating Pharmacometric Workflows with AI Coding Assistants,Ercan Sükür, Roche Designing and Evaluating approaches for pharmacometrics modeling with generative AI,Benjamin Olsson/ Mikael - [Conferences we are attending in 2025](https://pharmetheus.com/events/overview-midd-pharmacology-related-conferences-and-meetings-2025/) - Plan your participation This list highlights the pharmacology conferences and meetings Pharmetheus will attend in 2025, offering an overview of key and emerging events in the field. It is designed to help you identify opportunities to connect with us. The list will be updated regularly as dates and locations are announced. Meet Pharmetheus - get - [Privacy Policy](https://pharmetheus.com/privacy-policy/) - 1. General This privacy policy (the “Privacy Policy”) describes how Pharmetheus AB, corp. reg. no. 556895-6352, Kungsängstull 4, 753 19 Uppsala, Sweden (“Pharmetheus”, “we”, “us” ), processes personal data about you as a company representative for customers, partners or suppliers of Pharmetheus, as a visitor to www.pharmetheus.com or when you apply for a job position - [L'empouvoirement par l’éducation : Formation en ligne de pharmacologie clinique et la pharmacométrie en français](https://pharmetheus.com/fr-csr-pharmetheus-pharmacometrics-africa/) - Soucieuse de permettre une formation inclusive en Afrique, l'organisation à but non lucratif Pharmacometrics Africa, avec le soutien de Pharmetheus et de professeurs francophones, a lancé une version française de son cours en ligne de pharmacologie clinique et de pharmacométrie. Le programme est adapté aux scientifiques francophones d’Afrique et s’étend sur trois mois. – Les - [Time to register for the Educational Pharmacometrics Summer Symposium 2025](https://pharmetheus.com/events/epss-page-2025/) - Don't miss the chance to attend the fourth annual EPSS in connection to PAGE 2025 in Thessaloniki, Greece! - [Time to register for the Educational Pharmacometrics Summer Symposium 2024](https://pharmetheus.com/events/epss-page-2024/) - EPSS is organized in connection to the PAGE conference, each year at a different location. Boehringer Ingelheim and Pharmetheus support the symposium, together with a local university. Dr. Jurij Aguiar Zdovc, Consultant at Pharmetheus, is supporting EPSS as a Pharmetheus CSR initiative under the goal of quality education and reducing inequalities: "Each year, we strive - [“My initial impressions of Pharmetheus turned out to be entirely true.“

](https://pharmetheus.com/careers/employee-stories/patrik-ejerhed/) - Considering a career at Pharmetheus? Read Patrik Ejerhed's story – learn about our unique company culture, scientific opportunities, and professional growth. - [Pharmetheus at ACoP 2025](https://pharmetheus.com/events/pharmetheus-at-acop-2025/) - Explore our posters and scientific sessions at ACoP 2025. - [ACoP 2025 workshop: FREM in practical use - implementation and interpretation](https://pharmetheus.com/events/workshop-acop-2025-frem-in-practical-use-implementation-and-interpretation/) - Join this workshop at ACoP 2025 for hands-on training in applying FREM effectively for robust decision-making in pharmacometrics. - [Cookie Policy](https://pharmetheus.com/cookie-policy/) - We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept”, you consent to the use of ALL the cookies. However you may visit Cookie Settings to provide a controlled consent Advertisement Advertisement cookies are used to provide visitors with relevant ads and - ["We don't just produce and deliver – we care"](https://pharmetheus.com/careers/employee-stories/viviana-moroso/) - Viviana splits her time between QC work and medical writing. In the QC role, she meticulously reviews analyses, programming code, statistical models and reports produced by her pharmacometrician colleagues, ensuring that every word, figure, value and table holds up under scrutiny. Another important aspect is maintaining objectivity and impartiality; in practice this means that QC - [Pharmetheus at PAGE 2025](https://pharmetheus.com/events/pharmetheus-at-page-2025/) - Explore our posters and scientific sessions at PAGE 2025. We'd love to meet you - use this form to book a meeting with us - [Pharmetheus at ASCPT 2025](https://pharmetheus.com/events/ascpt-2025-meet-the-team-from-pharmetheus/) - This year's theme “Patient-Centric Clinical Pharmacology: A Journey from Discovery to Recovery” highlight the vital role of patients as the central stakeholders in health care. We look forward to engaging sessions that embrace patient-centricity across the entire DDRU continuum—empowering us all to drive more significant impact. We'll be attending ASCPT - get in touch to - [Symposium: MIDD in regulatory interactions – Practical takes on the Draft ICH M15 Guideline](https://pharmetheus.com/events/pharmetheus-at-page-2025/symposium-midd-in-regulatory-interactions-ich-m15-2025/) - Objective The aim of this satellite symposium is to reflect on the current use of MIDD in regulatory interactions and propose practical ideas on how the Draft ICH M15 Guidelines on “General principles for model-informed drug development” can be put into action. See the document at database.ich.org Audience The symposium is intended for everyone interested - [Chasing optimum First-in-Human dose – welcome to reality!](https://pharmetheus.com/events/workshop-gmp-2025-chasing-optimum-fih-dose/) - Agenda highlights Getting the FIH dose right: Transforming Preclinical Knowledge into Clinical ApplicationsAntoine Deslandes, Sanofi Physiologically Based Pharmacokinetics (PBPK) modeling to support First-in-Human studies of small moleculesFrançois Bouzom, Simulations Plus Knowledge Sharing on specific challenges for FIH dose predictionsGlenn Gauderat, Servier Working with Probability of Pharmacological Success (PoPS) to Inform FIH StudiesMartin Bergstrand, Pharmetheus Dr. - [Workshop: PBPK Modeling for First-in-Human & DDI with OSP Suite](https://pharmetheus.com/events/pharmetheus-at-page-2025/workshop-page2025-pbpk-modeling-for-fih-ddi-with-osp-suite/) - Workshop in connection to PAGE 2025 - Thessaloniki, Greece Join us for an interactive two-day workshop where you will gain hands-on experience with physiologically-based pharmacokinetic (PBPK) modeling using the well-established whole-body PBPK model in PK-Sim® and the open modeling capabilities of MoBi®. Learn how to apply PBPK modeling to First-in-Human (FIH) studies and Drug-Drug Interactions - [Subcutaneous drug delivery: PBPK-QSP model for absorption and anti-drug antibody response](https://pharmetheus.com/subcutaneous-drug-delivery-pbpk-qsp-model-for-absorption-and-anti-drug-antibody-response/) - The subcutaneous route of administration provides convenient and non-inferior delivery of therapeutic proteins compared to intravenous infusion. However, similarly to intravenous administration, there is a potential risk for undesirable effects such as anti-drug antibody emergence toward these therapeutic proteins [1]. The risk for immunogenicity can be mitigated to a certain degree by compound prioritization and - [Good health and well-being](https://pharmetheus.com/about-us/corporate-social-responsibility/good-health-and-well-being/) - Over the last 15 years, the number of childhood deaths has been cut in half. This proves that it is possible to win the fight against almost every disease. Still, we are spending an astonishing amount of money and resources on treating illnesses that are surprisingly easy to prevent. The new goal for worldwide Good - [Whistleblower](https://pharmetheus.com/whistleblower/) - At Pharmetheus, we prioritize integrity and transparency. To uphold these values, we offer a secure and confidential whistleblower portal. This platform allows individuals to report potential misconduct, ensuring that concerns are reviewed impartially by a third party. By providing this resource, we aim to maintain an ethical environment where all stakeholders feel empowered to voice - [LUMI Office - Pharmetheus new Uppsala HQ](https://pharmetheus.com/lumi-office-pharmetheus-new-uppsala-hq/) - [Workshop: 'PBPK-PD/QSP modeling with the OSPSuite (PK-Sim®, MoBi®)'](https://pharmetheus.com/2023_june_pbpk_page_workshop/) - The workshop will feature PBPK and PD/QSP modeling with the Open Systems Pharmacology (OSP) suite also known as PK-Sim® and MoBi®. The focus will be on how to leverage the open source platforms PK-Sim® and MoBi® to utilize the standardized and well established whole body PBPK model provided in PK-Sim® and combine it with the - [Symposium: Opportunities for MIDD for cell therapies](https://pharmetheus.com/events/2023_november_midd_acop_symposium/) - Symposium session, November 6, 2.30 - 4.00 PM Model-based optimization for (CAR-T) Cell Therapies - The current state of affairs and a way forward. Anna Mc Laughlin, Dr. rer.nat, Consultant. PharmetheusCassian Yee, Professor, University of Texas MD Anderson Cancer Center Cellular therapy, especially chimeric antigen receptor (CAR)-T cell therapy, has revolutionized the treatment of relapsed/refractory - [Integrity](https://pharmetheus.com/integrity/) - We are true to ourselves and honest with each other and our clients, while considering what is best for patients. As we do so, we also care about how our words and actions may impact others, and accept individual differences. - ["I'm a little proud of our company all the time"](https://pharmetheus.com/careers/employee-stories/siv-jonsson/) - Why did you initially join Pharmetheus? It was a good time for a change of scenery for me, and Pharmetheus was the obvious choice. I had heard really good things about the company, I knew some of the founders and people who worked there. Before I joined Pharmetheus, I had worked for many years in - [Collaboration](https://pharmetheus.com/collaboration/) - We work as a team, together and with clients, towards achieving a common goal by sharing ideas and skills. As we do so, we learn and develop, as individuals and as a team. - [Dedication](https://pharmetheus.com/dedication/) - We are devoted to supporting the needs of our clients through the passion for our work. As we do so, we take actions and accountability for the projects entrusted by our clients. ## People - [Richard Anziano](https://pharmetheus.com/about-us/people/richard-anziano/) - Read more about Richard Anziano︱ Biography ︱ Links ︱ Publications by Anziano RJ - [Lina Keutzer](https://pharmetheus.com/about-us/people/lina-keutzer/) - Read more about Lina Keutzer︱ Biography ︱ Links ︱ Publications by - [Bram Agema](https://pharmetheus.com/about-us/people/bram-agema/) - Read more about Bram Agema︱ Biography ︱ Links ︱ Publications by - [Ulrika Wählby Hamrén](https://pharmetheus.com/about-us/people/ulrika-wahlby-hamren/) - Read more about Ulrika Wählby Hamrén︱ Biography ︱ Links ︱ Publications by - [Anna Mc Laughlin](https://pharmetheus.com/about-us/people/anna-mc-laughlin/) - Read more about Anna Mc Laughlin︱ Biography ︱ Links ︱ Publications by Mc Laughlin AM - [Jonas Möller](https://pharmetheus.com/about-us/people/jonas-moller/) - Read more about Jonas Möller︱ Biography ︱ Links ︱ Publications by - [Peter Milligan](https://pharmetheus.com/about-us/people/peter-milligan/) - Read more about Peter Milligan︱ Biography ︱ Links ︱ Publications by Milligan PA - [Martina Lundgren](https://pharmetheus.com/about-us/people/martina-lundgren/) - Read more about Martina Lundgren︱ Biography ︱ Links ︱ Publications by - [Sebastian Tandar](https://pharmetheus.com/about-us/people/sebastian-tandar/) - Read more about Sebastian Tandar︱ Biography ︱ Links ︱ Publications by - [Helena Loer](https://pharmetheus.com/about-us/people/helena-loer/) - Read more about Helena Loer︱ Biography ︱ Links ︱ Publications by - [Jurij Aguiar Zdovc](https://pharmetheus.com/about-us/people/jurij-aguiar-zdovc/) - Read more about Jurij Aguiar Zdovc︱ Biography ︱ Links ︱ Publications by - [Xinyi Li](https://pharmetheus.com/about-us/people/xinyi-li/) - Read more about Xinyi Li︱ Biography ︱ Links ︱ Publications by - [Sophie Peigné](https://pharmetheus.com/about-us/people/sophie-peigne/) - Read more about Sophie Peigné︱ Biography ︱ Links ︱ Publications by - [Catalina Barceló](https://pharmetheus.com/about-us/people/catalina-barcelo/) - Read more about Catalina Barceló︱ Biography ︱ Links ︱ Publications by - [Giovanni Smania](https://pharmetheus.com/about-us/people/giovanni-smania/) - Read more about Giovanni Smania︱ Biography ︱ Links ︱ Publications by Smania G - [Maddlie Bardol](https://pharmetheus.com/about-us/people/maddlie-bardol/) - Read more about Maddlie Bardol︱ Biography ︱ Links ︱ Publications by - [Ari Brekkan](https://pharmetheus.com/about-us/people/ari-brekkan/) - Read more about Ari Brekkan︱ Biography ︱ Links ︱ Publications by Brekkan A - [Jurgen Langenhorst](https://pharmetheus.com/about-us/people/jurgen-langenhorst/) - Read more about Jurgen Langenhorst︱ Biography ︱ Links ︱ Publications by Langenhorst J - [Oskar Clewe](https://pharmetheus.com/about-us/people/oskar-clewe/) - Read more about Oskar Clewe︱ Biography ︱ Links ︱ Publications by - [Marylore Chenel](https://pharmetheus.com/about-us/people/marylore-chenel/) - Read more about Marylore ︱ Biography ︱ Links ︱ Publications by Chenel M - [Céline Sarr](https://pharmetheus.com/about-us/people/celine-sarr/) - Read more about Céline Sarr︱ Biography ︱ Links ︱ Publications by Sarr C - [Maarten van Eijk](https://pharmetheus.com/about-us/people/maarten-van-eijk/) - Read more about Maarten van Eijk︱ Biography ︱ Links ︱ Publications by - [Félicien Le Louedec](https://pharmetheus.com/about-us/people/felicien-le-louedec/) - Read more about Félicien Le Louedec︱ Biography ︱ Links ︱ Publications by - [David Damoiseaux](https://pharmetheus.com/about-us/people/david-damoiseux/) - Read more about David Damoiseux︱ Biography ︱ Links ︱ Publications by Damoiseaux D - [Viviana Moroso](https://pharmetheus.com/about-us/people/viviana-moroso/) - Read more about Viviana Moroso︱ Biography ︱ Links ︱ Publications by Moroso V - [Anna Pousette](https://pharmetheus.com/about-us/people/anna-pousette/) - Read more about Anna Pousette︱ Biography ︱ Links ︱ Publications by - [Ulrika Simonsson](https://pharmetheus.com/about-us/people/ulrika-simonsson/) - Read more about Ulrika Simonsson︱ Biography ︱ Links ︱ Publications by - [Elodie Plan](https://pharmetheus.com/about-us/people/elodie-plan/) - Read more about Elodie Plan︱ Biography ︱ Links ︱ Publications by Plan EL - [Jakob Ribbing](https://pharmetheus.com/about-us/people/jakob-ribbing/) - Read more about Jakob ︱ Biography ︱ Links ︱ Publications by Ribbing J - [Lourdes Cucurull-Sanchez](https://pharmetheus.com/about-us/people/lourdes-cucurull-sanchez/) - Read more about Lourdes Cucurull-Sanchez︱ Biography ︱ Links ︱ Publications by - [Erik Sjögren](https://pharmetheus.com/about-us/people/erik-sjogren/) - Read more about Erik Sjögren︱ Biography ︱ Links ︱ Publications by Sjögren E - [Martin Bergstrand](https://pharmetheus.com/about-us/people/martin-bergstrand/) - Read more about Martin Bergstrand︱ Biography ︱ Links ︱ Publications by Bergstrand M - [Niclas Jonsson](https://pharmetheus.com/about-us/people/niclas-jonsson/) - Read more about Niclas Jonsson︱ Biography ︱ Links ︱ Publications by Jonsson EN - [Emma Ångström](https://pharmetheus.com/about-us/people/emma-angstrom/) - Read more about Emma Ångström︱ Biography ︱ Links ︱ Publications by - [Henrietta Sahl](https://pharmetheus.com/about-us/people/henrietta-sahl/) - Read more about Henrietta Sahl︱ Biography ︱ Links ︱ Publications by - [Alina Kagermazova](https://pharmetheus.com/about-us/people/alina-kagermazova/) - Read more about Alina Kagermazova︱ Biography ︱ Links ︱ Publications by - [Joakim Nyberg](https://pharmetheus.com/about-us/people/joakim-nyberg/) - Read more about Joakim Nyberg︱ Biography ︱ Links ︱ Publications by Nyberg J - [Marcus Björnsson](https://pharmetheus.com/about-us/people/marcus-bjornsson/) - Read more about Marcus Björnsson︱ Biography ︱ Links ︱ Publications by Björnsson MA - [Henrik Bjugård Nyberg](https://pharmetheus.com/about-us/people/henrik-bjugard-nyberg/) - Read more about Henrik Bjugård Nyberg︱ Biography ︱ Links ︱ Publications by - [Patrik Ejerhed](https://pharmetheus.com/about-us/people/patrik-ejerhed/) - Read more about Patrik Ejerhed︱ Biography ︱ Links ︱ Publications by - [Quentin Leirens](https://pharmetheus.com/about-us/people/quentin-leirens/) - Read more about Quentin Leirens︱ Biography ︱ Links ︱ Publications by Leirens Q - [Samia Mohamed](https://pharmetheus.com/about-us/people/samia-mohamed/) - Read more about Samia Mohamed︱ Biography ︱ Links ︱ Publications by - [Malin Gidlund](https://pharmetheus.com/about-us/people/malin-gidlund/) - Read more about Malin Gidlund︱ Biography ︱ Links ︱ Publications by - [Chayan Acharya](https://pharmetheus.com/about-us/people/chayan-acharya/) - Read more about Chayan Acharya︱ Biography ︱ Links ︱ Publications by Acharya C - [Tobias Kanacher](https://pharmetheus.com/about-us/people/tobias-kanacher/) - Read more about Tobias Kanacher︱ Biography ︱ Links ︱ Publications by Kanacher T - [Svetlana Freiberga](https://pharmetheus.com/about-us/people/svetlana-freiberga/) - Read more about Svetlana Freiberga︱ Biography ︱ Links ︱ Publications by - [Stijn van Beek](https://pharmetheus.com/about-us/people/stijn-van-beek/) - Read more about Stijn van Beek︱ Biography ︱ Links ︱ Publications by - [Sofia Friberg Hietala](https://pharmetheus.com/about-us/people/sofia-friberg-hietala/) - Read more about Sofia Friberg Hietala︱ Biography ︱ Links ︱ Publications by Friberg Hietala S - [Siv Jönsson](https://pharmetheus.com/about-us/people/siv-jonsson/) - Read more about Siv Jönsson︱ Biography ︱ Links ︱ Publications by Jönsson S - [Sami Ullah](https://pharmetheus.com/about-us/people/sami-ullah/) - Read more about Sami Ullah︱ Biography ︱ Links ︱ Publications by - [Rujia Xie](https://pharmetheus.com/about-us/people/rujia-xie/) - Read more about Rujia Xie︱ Biography ︱ Links ︱ Publications by - [Rami Ayoun Alsoud](https://pharmetheus.com/about-us/people/rami-ayoun-alsoud/) - Read more about Rami Ayoun Alsoud︱ Biography ︱ Links ︱ Publications by - [Qing Xi Ooi](https://pharmetheus.com/about-us/people/qing-xi-ooi/) - Read more about Qing Xi Ooi︱ Biography ︱ Links ︱ Publications by Ooi QX - [Peteris Prusis](https://pharmetheus.com/about-us/people/peteris-prusis/) - Read more about Peteris Prusis︱ Biography ︱ Links ︱ Publications by - [Paul Vrenken](https://pharmetheus.com/about-us/people/paul-vrenken/) - Read more about Paul Vrenken︱ Biography ︱ Links ︱ Publications by - [Mounika Suddapalli](https://pharmetheus.com/about-us/people/mounika-suddapalli/) - Read more about ︱ Biography ︱ Links ︱ Publications by - [Moriah Pellowe](https://pharmetheus.com/about-us/people/moriah-pellowe/) - Read more about Moriah Pellowe︱ Biography ︱ Links ︱ Publications by - [Mikael Ringh](https://pharmetheus.com/about-us/people/mikael-ringh/) - Read more about Mikael Ringh︱ Biography ︱ Links ︱ Publications by - [Mats Magnusson](https://pharmetheus.com/about-us/people/mats-magnusson/) - Read more about Mats Magnusson︱ Biography ︱ Links ︱ Publications by Magnusson MO - [Marie Wijk](https://pharmetheus.com/about-us/people/marie-wijk/) - Read more about Marie Wijk︱ Biography ︱ Links ︱ Publications by - [Marie Sandström](https://pharmetheus.com/about-us/people/marie-sandstrom/) - Read more about Marie Sandström︱ Biography ︱ Links ︱ Publications by - [Lénaïg Tanneau](https://pharmetheus.com/about-us/people/lenaig-tanneau/) - Read more about Lénaïg Tanneau︱ Biography ︱ Links ︱ Publications by - [Kamunkhwala Gausi](https://pharmetheus.com/about-us/people/kamunkhwala-gausi/) - Read more about Kamunkhwala Gausi︱ Biography ︱ Links ︱ Publications by - [Julie Janssen](https://pharmetheus.com/about-us/people/julie-janssen/) - Read more about Julie Janssen︱ Biography ︱ Links ︱ Publications by - [Johanna Eriksson](https://pharmetheus.com/about-us/people/johanna-eriksson/) - Read more about Johanna Eriksson︱ Biography ︱ Links ︱ Publications by - [Joakim Hellner](https://pharmetheus.com/about-us/people/joakim-hellner/) - Read more about Joakim Hellner︱ Biography ︱ Links ︱ Publications by - [Ida Neldemo](https://pharmetheus.com/about-us/people/ida-neldemo/) - Read more about Ida Neldemo︱ Biography ︱ Links ︱ Publications by Netterberg I - [Gianluca Selvaggio](https://pharmetheus.com/about-us/people/gianluca-selvaggio/) - Read more about Gianluca Selvaggio︱ Biography ︱ Links ︱ Publications by - [Georges Etté](https://pharmetheus.com/about-us/people/georges-ette/) - Read more about Georges Etté︱ Biography ︱ Links ︱ Publications by - [Fanny Gallais](https://pharmetheus.com/about-us/people/fanny-gallais/) - Read more about Fanny Gallais︱ Biography ︱ Links ︱ Publications by - [Enrica Mezzalana](https://pharmetheus.com/about-us/people/enrica-mezzalana/) - Read more about Enrica Mezzalana︱ Biography ︱ Links ︱ Publications by Mezzalana E - [Emma Hansson](https://pharmetheus.com/about-us/people/emma-hansson/) - Read more about Emma Hansson︱ Biography ︱ Links ︱ Publications by Hansson E - [Emma Eckernäs](https://pharmetheus.com/about-us/people/emma-eckernas/) - Read more about Emma Eckernäs︱ Biography ︱ Links ︱ Publications by - [Chun Liu](https://pharmetheus.com/about-us/people/chun-liu/) - Read more about Chun Liu︱ Biography ︱ Links ︱ Publications by - [Christina Pentafragka](https://pharmetheus.com/about-us/people/christina-pentafragka/) - Read more about Christina Pentafragka︱ Biography ︱ Links ︱ Publications by - [Christina Kovar](https://pharmetheus.com/about-us/people/christina-kovar/) - Read more about Christina Kovar︱ Biography ︱ Links ︱ Publications by - [Carolina Llanos Páez](https://pharmetheus.com/about-us/people/carolina-llanos-paez/) - Read more about Carolina Llanos Páez︱ Biography ︱ Links ︱ Publications by - [Bastian Kister](https://pharmetheus.com/about-us/people/bastian-kister/) - Read more about Bastian Kister︱ Biography ︱ Links ︱ Publications by - [Arnaud Gaby](https://pharmetheus.com/about-us/people/arnaud-gaby/) - Read more about Arnaud Gaby︱ Biography ︱ Links ︱ Publications by - [Anyue Yin](https://pharmetheus.com/about-us/people/anyue-yin/) - Read more about Anyue Yin︱ Biography ︱ Links ︱ Publications by - [Annika Eklund](https://pharmetheus.com/about-us/people/annika-eklund/) - Read more about Annika Eklund︱ Biography ︱ Links ︱ Publications by - [Anna Chan Kwong](https://pharmetheus.com/about-us/people/anna-chan-kwong/) - Read more about Anna Chan Kwong︱ Biography ︱ Links ︱ Publications by - [Andrea Henrich](https://pharmetheus.com/about-us/people/andrea-henrich/) - Read more about Andrea Henrich︱ Biography ︱ Links ︱ Publications by Henrich A - [Anaïs Glatard](https://pharmetheus.com/about-us/people/anais-glatard/) - Read more about Anaïs Glatard︱ Biography ︱ Links ︱ Publications by Glatard A - [Anders Kristoffersson](https://pharmetheus.com/about-us/people/anders-kristoffersson/) - Read more about Anders Kristoffersson︱ Biography ︱ Links ︱ Publications by Kristoffersson A - [Alexandra Lavalley-Morelle](https://pharmetheus.com/about-us/people/alexandra-lavalley-morelle/) - Read more about Alexandra Lavalley-Morelle︱ Biography ︱ Links ︱ Publications by - [Eman Ibrahim](https://pharmetheus.com/about-us/people/eman-ibrahim/) - Read more about Eman Ibrahim︱ Biography ︱ Links ︱ Publications by Ibrahim EIK - [Benjamin Weber](https://pharmetheus.com/about-us/people/benjamin-weber/) - Read more about Benjamin Weber︱ Biography ︱ Links ︱ Publications by - [Mikael Haglund](https://pharmetheus.com/about-us/people/mikael-haglund/) - Read more about Mikael Haglund︱ Biography ︱ Links ︱ Publications by - [Lena Lindeberg](https://pharmetheus.com/about-us/people/lena-lindeberg/) - Read more about Lena Lindeberg︱ Biography ︱ Links ︱ Publications by - [Tom Tensfeldt](https://pharmetheus.com/about-us/people/tom-tensfeldt/) - Read more about Tom Tensfeldt︱ Biography ︱ Links ︱ Publications by - [René Bruno](https://pharmetheus.com/about-us/people/rene-bruno/) - Read more about René Bruno︱ Biography ︱ Links ︱ Publications by - [France Mentré](https://pharmetheus.com/about-us/people/france-mentre/) - Read more about France Mentré︱ Biography ︱ Links ︱ Publications by - [Magnus Forsbrand](https://pharmetheus.com/about-us/people/magnus-forsbrand/) - Read more about Magnus Forsbrand︱ Biography ︱ Links ︱ Publications by - [Sverre Bengtsson](https://pharmetheus.com/about-us/people/sverre-bengtsson/) - Read more about ︱ Biography ︱ Links ︱ Publications by - [Nina Englund](https://pharmetheus.com/about-us/people/nina-englund/) - Read more about Nina Englund︱ Biography ︱ Links ︱ Publications by - [Andrew Hooker](https://pharmetheus.com/about-us/people/andrew-hooker/) - Read more about Andrew Hooker︱ Biography ︱ Links ︱ Publications by - [Mats Karlsson](https://pharmetheus.com/about-us/people/mats-karlsson/) - Read more about Mats Karlsson︱ Biography ︱ Links ︱ Publications by Karlsson MO - [Lena Friberg](https://pharmetheus.com/about-us/people/lena-friberg/) - Read more about Lena Friberg︱ Biography ︱ Links ︱ Publications by Friberg LE - [Birgit Köster Hoffman](https://pharmetheus.com/about-us/people/birgit-koster-hoffman/) - Read more about Birgit Köster Hoffman︱ Biography ︱ Links ︱ Publications by ## Teams - [Consultants](https://pharmetheus.com/about-us/our-team/consultants/) - [Client relations](https://pharmetheus.com/about-us/our-team/client-relations/) - [Research & Development](https://pharmetheus.com/about-us/our-team/rd/) ## Publications - [Model-based Analysis with Mechanistic Insights to CAR-T Cell Therapy Kinetics: Case Study with Axicabtagene Ciloleucel and Brexucabtagene Autoleucel](https://pharmetheus.com/publications/model-based-analysis-with-mechanistic-insights-to-car-t-cell-therapy-kinetics-case-study-with-axicabtagene-ciloleucel-and-brexucabtagene-autoleucel/) - [Coproporphyrin I PBPK model in the open systems pharmacology suite enables precise prediction of OATP 1B- mediated drug interactions through calibrated In vivo inhibition constants](https://pharmetheus.com/publications/coproporphyrin-i-pbpk-model-in-the-open-systems-pharmacology-suite-enables-precise-prediction-of-oatp-1b-mediated-drug-interactions-through-calibrated-in-vivo-inhibition-constants/) - [Large Language Model-Supported Data Collation: Addressing Accuracy and Reproducibility](https://pharmetheus.com/publications/large-language-model-supported-data-collation-addressing-accuracy-and-reproducibility/) - [Model-integrated evidence: A vision to expand the role of modeling in drug development and regulatory decision-making](https://pharmetheus.com/publications/model-integrated-evidence-a-vision-to-expandthe-role-of-modeling-in-drug-development-andregulatory-decision-making/) - [Population pharmacokinetics and exposure-response analyses of navepegritide in children with achondroplasia](https://pharmetheus.com/publications/population-pharmacokinetics-and-exposure-response-analyses-of-navepegritide-in-children-with-achondroplasia/) - [Usage and regulatory acceptance of PBPK models in paediatric drug applications: a review of EMA and FDA public assessment reports](https://pharmetheus.com/publications/usage-and-regulatory-acceptance-of-pbpk-models-in-paediatric-drug-applications-a-review-of-ema-and-fda-public-assessment-reports/) - [Rock and roll – deliverables driven by standardized data specifications](https://pharmetheus.com/publications/rock-and-roll-deliverables-driven-by-standardized-data-specifications/) - [Implementing a full random effects model (FREM) workflow in R using the saemix package](https://pharmetheus.com/publications/implementing-a-full-random-effects-model-frem-workflow-in-r-using-the-saemix-package/) - [Benchmarking a mechanistic immunogenicity framework: aligning sequence-based epitope predictions with clinical observations](https://pharmetheus.com/publications/benchmarking-a-mechanistic-immunogenicity-framework-aligning-sequence-based-epitope-predictions-with-clinical-observations/) - [Reference-corrected VPCs: addressing model evaluation challenges with real-world data and adaptive designs](https://pharmetheus.com/publications/reference-corrected-vpcs-addressing-model-evaluation-challenges-with-real-world-data-and-adaptive-designs/) - [The decision-equivalence metric (DEM) method based evaluation of biomarker surrogacy in MASH](https://pharmetheus.com/publications/the-decision-equivalence-metric-dem-method-based-evaluation-of-biomarker-surrogacy-in-mash/) - [Model-informed pediatric drug development for clevidipine](https://pharmetheus.com/publications/model-informed-pediatric-drug-development-for-clevidipine/) - [A structured approach to pharmacometric covariate modelling: why the estimand is the first decision and the method the second](https://pharmetheus.com/publications/a-structured-approach-to-pharmacometric-covariate-modelling-why-the-estimand-is-the-first-decision-and-the-method-the-second/) - [Model-informed fixed dosing of rozanolixizumab in gMG: PK/PD advantages and comparison with other FcRn blockers](https://pharmetheus.com/publications/model-informed-fixed-dosing-of-rozanolixizumab-in-gmg-pk-pd-advantages-and-comparison-with-other-fcrn-blockers/) - [Visual predictive checks for real-world data using propensity-score-matching](https://pharmetheus.com/publications/visual-predictive-checks-for-real-world-data-using-propensity-score-matching/) - [The use of full random effect models (FREM) in model informed precision dosing (MIPD) for a priori dose predictions](https://pharmetheus.com/publications/the-use-of-full-random-effect-models-frem-in-model-informed-precision-dosing-mipd-for-a-priori-dose-predictions/) - [A mechanism-based parsimonious CAR-T cell population PK model and its validation via extension to a population PK-tumor size dynamics model: case study with axicabtagene ciloleucel and brexucabtagene autoleucel](https://pharmetheus.com/publications/a-mechanism-based-parsimonious-car-t-cell-population-pk-model-and-its-validation-via-extension-to-a-population-pk-tumor-size-dynamics-model-case-study-with-axicabtagene-ciloleucel-and-brexucabtagene/) - [Use AUC and discard Cmax in exposure-response analyses: a global sensitivity and stochastic simulation-estimation study](https://pharmetheus.com/publications/use-auc-and-discard-cmax-in-exposure-response-analyses-a-global-sensitivity-and-stochastic-simulation-estimation-study/) - [Direct and hybrid machine learning approaches do not outperform NLME-based full Bayesian forecasting for early identification of delayed methotrexate elimination](https://pharmetheus.com/publications/direct-and-hybrid-machine-learning-approaches-do-not-outperform-nlme-based-full-bayesian-forecasting-for-early-identification-of-delayed-methotrexate-elimination/) - [Apparent time dependence and rethinking random effect under single time-to-event models](https://pharmetheus.com/publications/apparent-time-dependence-and-rethinking-random-effect-under-single-time-to-event-models/) - [Food effect prediction of high permeability/low solubility, formulated as an amorphous solid dispersion (ASD) using an open systems pharmacology (OSP) PBBM approach](https://pharmetheus.com/publications/food-effect-prediction-of-high-permeability-low-solubility-formulated-as-an-amorphous-solid-dispersion-asd-using-an-open-systems-pharmacology-osp-pbbm-approach/) - [Integrating in silico epitope prediction and mechanistic QSP modeling for benchmarking immunogenicity risk](https://pharmetheus.com/publications/integrating-in-silico-epitope-prediction-and-mechanistic-qsp-modeling-for-benchmarking-immunogenicity-risk/) - [The visual predictive check and real-world data](https://pharmetheus.com/publications/the-visual-predictive-check-and-real-world-data/) - [Population pharmacokinetics and pharmacokinetics-pharmacodynamics analyses of elafibranor to support dose selection in primary biliary cholangitis](https://pharmetheus.com/publications/population-pharmacokinetics-and-pharmacokinetics-pharmacodynamics-analyses-of-elafibranor-to-support-dose-selection-in-primary-biliary-cholangitis/) - [Food effect prediction of a high permeability/low solubility drug formulated as an amorphous solid dispersion (ASD) using an Open Systems Pharmacology (OSP) PBBM approach](https://pharmetheus.com/publications/food-effect-prediction-of-a-high-permeability-low-solubility-drug-formulated-as-an-amorphous-solid-dispersion-asd-using-an-open-systems-pharmacology-osp-pbbm-approach/) - [PBPK modeling of subcutaneous absorption for monoclonal antibodies](https://pharmetheus.com/publications/pbpk-modeling-of-subcutaneous-absorption-for-monoclonal-antibodies/) - [An open-source PBBM integrating the particle drifting effect to predict human oral absorption of nanoparticle formulations](https://pharmetheus.com/publications/an-open-source-pbbm-integrating-the-particle-drifting-effect-to-predict-human-oral-absorption-of-nanoparticle-formulations/) - [PBPK workflow for predicting clinical DDI risk of OATP1B1/3 inhibitors utilizing the CP-I biomarker: A case study with cyclosporine A](https://pharmetheus.com/publications/pbpk-workflow-for-predicting-clinical-ddi-risk-of-oatp1b1-3-inhibitors-utilizing-the-cp-i-biomarker-a-case-study-with-cyclosporine-a/) - [Open-source PBPK modeling of artemether for pediatric extrapolations: integrating enzyme ontogeny, CYP2B6 auto-induction and malnutrition](https://pharmetheus.com/publications/open-source-pbpk-modeling-of-artemether-for-pediatric-extrapolations-integrating-enzyme-ontogeny-cyp2b6-auto-induction-and-malnutrition/) - [Population pharmacokinetics and pharmacodynamics of depemokimab in people with asthma and chronic rhinosinusitis with nasal polyps](https://pharmetheus.com/publications/population-pharmacokinetics-and-pharmacodynamics-of-depemokimab-in-people-with-asthma-and-chronic-rhinosinusitis-with-nasal-polyps/) - [Best Practices in Physiologically Based Pharmacokinetic (PBPK) Modeling](https://pharmetheus.com/publications/best-practices-in-physiologically-based-pharmacokinetic-pbpk-modeling/) - [A Longitudinal Disease Progression Model Characterizing Endoscopic Response and Remission in Crohn’s Disease](https://pharmetheus.com/publications/a-longitudinal-disease-progression-model-characterizing-endoscopic-response-and-remission-in-crohns-disease/) - [Accelerating subcutaneous drug development: A mechanistic absorption model for the Open Systems Pharmacology framework](https://pharmetheus.com/publications/accelerating-subcutaneous-drug-development-a-mechanistic-absorption-model-for-the-open-systems-pharmacology-framework/) - [A circular PK/PD/PK model explains the exposure of bulevirtide and bile salts in adult patients with Hepatitis D](https://pharmetheus.com/publications/a-circular-pk-pd-pk-model-explains-the-exposure-of-bulevirtide-and-bile-salts-in-adult-patients-with-hepatitis-d/) - [Dose Modifications in Exposure-Response Analyses of Oncology Drug Development: Brigimadlin Case Study](https://pharmetheus.com/publications/dose-modifications-in-exposure-response-analyses-of-oncology-drug-development-brigimadlin-case-study-2/) - [An item response theory model with bounded integer subcomponents to describe the Mayo Clinic subscores in patients with ulcerative colitis](https://pharmetheus.com/publications/an-item-response-theory-model-with-bounded-integer-subcomponents-to-describe-the-mayo-clinic-subscores-in-patients-with-ulcerative-colitis/) - [Quantitative Relationship Between Tominersen Concentrations in Cerebrospinal Fluid and Biomarker Changes in Huntington's Disease Patients](https://pharmetheus.com/publications/quantitative-relationship-between-tominersen-concentrations-in-cerebrospinal-fluid-and-biomarker-changes-in-huntingtons-disease-patients/) - [Model-Informed Drug Development in Small Populations](https://pharmetheus.com/publications/model-informed-drug-development-in-small-populations/) - [Open Systems Pharmacology Community Conference (OSP-CC) Proceedings 2025](https://pharmetheus.com/publications/open-systems-pharmacology-community-conference-osp-cc-proceedings-2025/) - [Population pharmacokinetic analysis of doxecitine and doxribtimine in patients with thymidine kinase 2 deficiency and in healthy volunteers](https://pharmetheus.com/publications/population-pharmacokinetic-analysis-of-doxecitine-and-doxribtimine-in-patients-with-thymidine-kinase-2-deficiency-and-in-healthy-volunteers/) - [Model-based approach for a new Prolonged-Release (PR) formulation of ivabradine: PK and PKPD assessment to support bioequivalence](https://pharmetheus.com/publications/model-based-approach-for-a-new-prolonged-release-pr-formulation-of-ivabradine-pk-and-pkpd-assessment-to-support-bioequivalence/) - [Predicting atorvastatin acid pharmacokinetics in a complex enzyme- and transporter-mediated drug–drug interaction network using physiologically based pharmacokinetic modeling](https://pharmetheus.com/publications/predicting-atorvastatin-acid-pharmacokinetics-in-a-complex-enzyme-and-transporter-mediated-drug-drug-interaction-network-using-physiologically-based-pharmacokinetic-modeling/) - [Population Pharmacokinetics and Exposure–Response Relationships of Etrolizumab in Patients with Moderately-to-Severely Active Crohn's Disease](https://pharmetheus.com/publications/population-pharmacokinetics-and-exposure-response-relationships-of-etrolizumab-in-patients-with-moderately-to-severely-active-crohns-disease/) - [Population pharmacokinetic analysis of an octreotide depot (CAM2029) in the treatment of acromegaly](https://pharmetheus.com/publications/population-pharmacokinetic-analysis-of-an-octreotide-depot-cam2029-in-the-treatment-of-acromegaly/) - [Assessing Drug–Drug Interaction and Food Effect for BCS Class 2 Compound BI 730357 (Retinoic Acid-Related Orphan Receptor Gamma Antagonist, Bevurogant) Using a Physiology-Based Pharmacokinetics Modeling (PBPK) Approach with Semi-Mechanistic Absorption](https://pharmetheus.com/publications/assessing-drug-drug-interaction-and-food-effect-for-bcs-class-2-compound-bi-730357-retinoic-acid-related-orphan-receptor-gamma-antagonist-bevurogant-using-a-physiology-based-pharmacokinetic/) - [Pharmacokinetic characterization and exposure–response relationship of crovalimab in the COMMODORE 1, 2 and 3 and COMPOSER trials of patients with paroxysmal nocturnal haemoglobinuria](https://pharmetheus.com/publications/pharmacokinetic-characterization-and-exposure-response-relationship-of-crovalimab-in-the-commodore-1-2-and-3-and-composer-trials-of-patients-with-paroxysmal-nocturnal-haemoglobinuria/) - [Bimekizumab population pharmacokinetic and exposure-response analyses in adults with moderate to severe hidradenitis suppurativa](https://pharmetheus.com/publications/bimekizumab-population-pharmacokinetic-and-exposure-response-analyses-in-adults-with-moderate-to-severe-hidradenitis-suppurativa/) - [A quantitative systems pharmacology framework of immunogenicity to propose mitigation strategies after subcutaneous administration](https://pharmetheus.com/publications/a-quantitative-systems-pharmacology-framework-of-immunogenicity-to-propose-mitigation-strategies-after-subcutaneous-administration/) - [Population pharmacokinetic and dose–response models of nepadutant, a selective antagonist of the NK₂ receptors, in infants with colic](https://pharmetheus.com/publications/population-pharmacokinetic-and-dose-response-models-of-nepadutant-a-selective-antagonist-of-the-nk2-receptors-in-infants-with-colic/) - [Population pharmacokinetics of survodutide in subjects with overweight or obesity with and without Type 2 Diabetes Mellitus based on Phase I and Phase II data](https://pharmetheus.com/publications/population-pharmacokinetics-of-survodutide-in-subjects-with-overweight-or-obesity-with-and-without-type-2-diabetes-mellitus-based-on-phase-i-and-phase-ii-data/) - [TransCon CNP (Navepegritide): A semi-mechanistic model to describe the prolonged half-life of C-type natriuretic peptide through TransConTM technology](https://pharmetheus.com/publications/transcon-cnp-navepegritide-a-semi-mechanistic-model-to-describe-the-prolonged-half-life-of-c-type-natriuretic-peptide-through-transcontm-technology/) - [Exploring the relationship between BI 456906 exposure and change in fasting plasma glucose, fasting serum insulin, and glycated hemoglobin (HbA1c) using population PKPD modeling](https://pharmetheus.com/publications/exploring-the-relationship-between-bi-456906-exposure-and-change-in-fasting-plasma-glucose-fasting-serum-insulin-and-glycated-hemoglobin-hba1c-using-population-pkpd-modeling/) - [A disease model predicting placebo response and remission status of patients with ulcerative colitis using modified Mayo score](https://pharmetheus.com/publications/a-disease-model-predicting-placebo-response-and-remission-status-of-patients-with-ulcerative-colitis-using-modified-mayo-score/) - [Use of informative prior distributions from mepolizumab data to support depemokimab PKPD model analysis](https://pharmetheus.com/publications/use-of-informative-prior-distributions-from-mepolizumab-data-to-support-depemokimab-pkpd-model-analysis/) - [Target engagement analysis of belimumab in patients with systemic lupus erythematosus (SLE) and primary Sjogren’s syndrome (pSS)](https://pharmetheus.com/publications/target-engagement-analysis-of-belimumab-in-patients-with-systemic-lupus-erythematosus-sle-and-primary-sjogrens-syndrome-pss/) - [Population Pharmacokinetics and Exposure-Response for Dapirolizumab Pegol From a Phase 2b Trial in Patients With Systemic Lupus Erythematosus](https://pharmetheus.com/publications/population-pharmacokinetics-and-exposure-response-for-dapirolizumab-pegol-from-a-phase-2b-trial-in-patients-with-systemic-lupus-erythematosus/) - [Efficacy and safety of the ghrelin-O-acyltransferase inhibitor BI 1356225 in overweight/obesity: Data from two Phase I, randomised, placebo-controlled studies](https://pharmetheus.com/publications/efficacy-and-safety-of-the-ghrelin-o-acyltransferase-inhibitor-bi-1356225-in-overweight-obesity-data-from-two-phase-i-randomised-placebo-controlled-studies/) - [Concentration QTc Analysis of Giredestrant: Overcoming QT/heart rate Confounding in the Presence of Drug-Induced Heart Rate Changes](https://pharmetheus.com/publications/concentration-qtc-analysis-of-giredestrant-overcoming-qt-heart-rate-confounding-in-the-presence-of-drug-induced-heart-rate-changes/) - [Bounded integer model-based analysis of psoriasis area and severity index in patients with moderate-to-severe plaque psoriasis receiving BI 730357](https://pharmetheus.com/publications/bounded-integer-model-based-analysis-of-psoriasis-area-and-severity-index-in-patients-with-moderate-to-severe-plaque-psoriasis-receiving-bi-730357/) - [An Item Response Theory Model with Bounded Integer Subcomponents to Describe the Mayo Clinic Subscores in Patients with Ulcerative Colitis [2]](https://pharmetheus.com/publications/an-item-response-theory-model-with-bounded-integer-subcomponents-to-describe-the-mayo-clinic-subscores-in-patients-with-ulcerative-colitis-2/) - [Imeglimin Population Pharmacokinetics and Dose Adjustment Predictions for Renal Impairment in Japanese and Western Patients with Type 2 Diabetes](https://pharmetheus.com/publications/imeglimin-population-pharmacokinetics-and-dose-adjustment-predictions-for-renal-impairment-in-japanese-and-western-patients-with-type-2-diabetes/) - [Population Pharmacokinetics of Tenecteplase in Patients With Acute Myocardial Infarction and Application to Patients With Acute Ischemic Stroke](https://pharmetheus.com/publications/population-pharmacokinetics-of-tenecteplase-in-patients-with-acute-myocardial-infarction-and-application-to-patients-with-acute-ischemic-stroke/) - [Bounded integer model-based analysis of psoriasis area and severity index in patients with moderate-to-severe plaque psoriasis receiving BI 730357 treatment](https://pharmetheus.com/publications/bounded-integer-model-based-analysis-of-psoriasis-area-and-severity-index-in-patients-with-moderate-to-severe-plaque-psoriasis-receiving-bi-730357-treatment/) - [Population pharmacokinetic analysis of etrolizumab in patients with moderately-to-severely active ulcerative colitis [2]](https://pharmetheus.com/publications/population-pharmacokinetic-analysis-of-etrolizumab-in-patients-with-moderately-to-severely-active-ulcerative-colitis-2/) - [How to Successfully Generate an Alternative Approach to a Thorough QT Study: GLPG1972 as an Example](https://pharmetheus.com/publications/how-to-successfully-generate-an-alternative-approach-to-a-thorough-qt-study-glpg1972-as-an-example/) - [Mechanistic Modeling of the Interplay Between Host Immune System, IL-7 and UCART19 Allogeneic CAR-T Cells in Adult B-cell Acute Lymphoblastic Leukemia](https://pharmetheus.com/publications/mechanistic-modeling-of-the-interplay-between-host-immune-system-il-7-and-ucart19-allogeneic-car-t-cells-in-adult-b-cell-acute-lymphoblastic-leukemia/) - [Population Pharmacokinetic Modelling and Simulation of Imeglimin in Type 2 Diabetes Patients to Support Dose Recommendations to Patients with Renal Impairment](https://pharmetheus.com/publications/population-pharmacokinetic-modelling-and-simulation-of-imeglimin-in-type-2-diabetes-patients-to-support-dose-recommendations-to-patients-with-renal-impairment/) - [Population Pharmacokinetic Analysis of Etrolizumab in Patients with Moderately-to-Severely Active Ulcerative Colitis](https://pharmetheus.com/publications/population-pharmacokinetic-analysis-of-etrolizumab-in-patients-with-moderately-to-severely-active-ulcerative-colitis/) - [The Population PKPD of Unacylated and Acylated Ghrelin Following Single Rising Doses of BI 1356225 in Healthy Subjects is Impacted by the Time Since Last Meal](https://pharmetheus.com/publications/the-population-pkpd-of-unacylated-and-acylated-ghrelin-following-single-rising-doses-of-bi-1356225-in-healthy-subjects-is-impacted-by-the-time-since-last-meal/) - [Exposure-Response Analysis of Etrolizumab in Patients with Moderately-to-severely Active Ulcerative Colitis](https://pharmetheus.com/publications/exposure-response-analysis-of-etrolizumab-in-patients-with-moderately-to-severely-active-ulcerative-colitis/) - [Population Pharmacokinetic and Exposure-Response Models for Dapirolizumab Pegol in Patients with Systemic Lupus Erythematosus](https://pharmetheus.com/publications/population-pharmacokinetic-and-exposure-response-models-for-dapirolizumab-pegol-in-patients-with-systemic-lupus-erythematosus/) - [Modeling and Simulation of the Modified Rankin Scale and National Institutes of Health Stroke Scale Neurological Endpoints in Intracerebral Hemorrhage](https://pharmetheus.com/publications/modeling-and-simulation-of-the-modified-rankin-scale-and-national-institutes-of-health-stroke-scale-neurological-endpoints-in-intracerebral-hemorrhage/) - [Population PK and PASI Exposure-Response Modelling for Certolizumab Pegol in Patients with Chronic Plaque Psoriasis](https://pharmetheus.com/publications/population-pk-and-pasi-exposure-response-modelling-for-certolizumab-pegol-in-patients-with-chronic-plaque-psoriasis/) - [Competing Risks Analysis of the Finnish Diabetes Prevention Study](https://pharmetheus.com/publications/competing-risks-analysis-of-the-finnish-diabetes-prevention-study/) - [Bridging Physiologically Based Pharmacokinetic (PBPK) and Population Pharmacokinetic (PopPK) Analyses in Paediatric Drug Development: A Case Study Based on Intravenous Esomeprazole](https://pharmetheus.com/publications/bridging-physiologically-based-pharmacokinetic-pbpk-and-population-pharmacokinetic-poppk-analyses-in-paediatric-drug-development-a-case-study-based-on-intravenous-esomeprazole/) - [Model-Based Prediction of Plasma Concentration and Enterohepatic Circulation of Total Bile Acids in Humans](https://pharmetheus.com/publications/model-based-prediction-of-plasma-concentration-and-enterohepatic-circulation-of-total-bile-acids-in-humans/) - [Exposure-Response Analyses Supporting Ticagrelor Dosing Recommendation in Patients With Prior Myocardial Infarction](https://pharmetheus.com/publications/exposure-response-analyses-supporting-ticagrelor-dosing-recommendation-in-patients-with-prior-myocardial-infarction/) - [Population Pharmacokinetics of Ticagrelor and AR-C124910XX in Patients with Prior Myocardial Infarction](https://pharmetheus.com/publications/population-pharmacokinetics-of-ticagrelor-and-ar-c124910xx-in-patients-with-prior-myocardial-infarction/) - [Pharmacokinetic and Exposure-Response Analyses Supporting Ticagrelor Dosing Recommendation in Patients with Prior Myocardial Infarction (PEGASUS-TIMI 54)](https://pharmetheus.com/publications/pharmacokinetic-and-exposure-response-analyses-supporting-ticagrelor-dosing-recommendation-in-patients-with-prior-myocardial-infarction-pegasus-timi-54/) - [Development of a Population Pharmacokinetic Model of Prucalopride in Children with Functional Constipation](https://pharmetheus.com/publications/development-of-a-population-pharmacokinetic-model-of-prucalopride-in-children-with-functional-constipation/) - [Translating Pharmacometrics to a Pharmacoeconomic Model of COPD](https://pharmetheus.com/publications/translating-pharmacometrics-to-a-pharmacoeconomic-model-of-copd/) - [Population PKPD Analysis of CD4 and ACR Response after SC Administration of Tregalizumab to Patients with Rheumatoid Arthritis](https://pharmetheus.com/publications/population-pkpd-analysis-of-cd4-and-acr-response-after-sc-administration-of-tregalizumab-to-patients-with-rheumatoid-arthritis/) - [Population Exposure-Response Modeling of Oral Nepadutant Administration in Infants with Colic](https://pharmetheus.com/publications/population-exposure-response-modeling-of-oral-nepadutant-administration-in-infants-with-colic/) - [Predicting Reductions in Chronic Obstructive Pulmonary Disease (COPD) Exacerbations from FEV1 – A Model-Based Meta-Analysis of Literature Data from Controlled Randomized Clinical Trials](https://pharmetheus.com/publications/predicting-reductions-in-chronic-obstructive-pulmonary-disease-copd-exacerbations-from-fev1-a-model-based-meta-analysis-of-literature-data-from-controlled-randomized-clinical-trials/) - [Modelling and Simulation of Neurological Endpoints (Modified Rankin Scale [mRS] and National Institute of Health Stroke Scale [NIHSS]) to Aid Clinical Trial Design in Intracerebral Hemorrhage (ICH)](https://pharmetheus.com/publications/modelling-and-simulation-of-neurological-endpoints-modified-rankin-scale-mrs-and-national-institute-of-health-stroke-scale-nihss-to-aid-clinical-trial-design-in-intracerebral-hemorrhage-ich/) - [A Model-Based Longitudinal Meta-Analysis of FEV1 in Randomized COPD Trials](https://pharmetheus.com/publications/a-model-based-longitudinal-meta-analysis-of-fev1-in-randomized-copd-trials/) - [Population Pharmacokinetics of Tanezumab in Phase 3 Clinical Trials for Osteoarthritis Pain](https://pharmetheus.com/publications/population-pharmacokinetics-of-tanezumab-in-phase-3-clinical-trials-for-osteoarthritis-pain/) - [Translational Modelling of Regular Human Insulin Pharmacokinetics and Glucose Dynamics in Minipig and Dog](https://pharmetheus.com/publications/translational-modelling-of-regular-human-insulin-pharmacokinetics-and-glucose-dynamics-in-minipig-and-dog/) - [A Bayesian Decision Support Tool for Efficient Dose Individualization of Warfarin in Adults and Children](https://pharmetheus.com/publications/a-bayesian-decision-support-tool-for-efficient-dose-individualization-of-warfarin-in-adults-and-children/) - [Application of a Semi-Mechanistic, Integrated Glucose-Insulin Model to Graded Glucose Infusion Placebo Data to translate Glucose Insulin dynamics between Healthy Humans and Non-Human Primates](https://pharmetheus.com/publications/application-of-a-semi-mechanistic-integrated-glucose-insulin-model-to-graded-glucose-infusion-placebo-data-to-translate-glucose-insulin-dynamics-between-healthy-humans-and-non-human-primates/) - [A Population PK/PD Analysis of Nebivolol and Valsartan Combination Therapy](https://pharmetheus.com/publications/a-population-pk-pd-analysis-of-nebivolol-and-valsartan-combination-therapy/) - [A Population PK Analysis of Nebivolol and Valsartan in Combination Therapy](https://pharmetheus.com/publications/a-population-pk-analysis-of-nebivolol-and-valsartan-in-combination-therapy/) - [Population PKPD Analysis of Weekly Pain Scores after Intravenously Administered Tanezumab, Based on Pooled Phase 3 Data in Patients with Osteoarthritis of the Knee or Hip](https://pharmetheus.com/publications/population-pkpd-analysis-of-weekly-pain-scores-after-intravenously-administered-tanezumab-based-on-pooled-phase-3-data-in-patients-with-osteoarthritis-of-the-knee-or-hip/) - [Characterizing Variability in Warfarin Dose Requirements in Children Using Modelling and Simulation](https://pharmetheus.com/publications/characterizing-variability-in-warfarin-dose-requirements-in-children-using-modelling-and-simulation/) - [Model-based bioequivalence methods open new doors for generics](https://pharmetheus.com/publications/model-based-bioequivalence-methods-open-new-doors-for-generics/) - [Conditional versus unconditional covariate effects in pharmacometric models: implications for interpretation, communication, and reporting](https://pharmetheus.com/publications/conditional-versus-unconditional-covariate-effects-in-pharmacometric-models-implications-for-interpretation-communication-and-reporting/) - [Risks encountered when not adjusting for diurnal variation and food effect in QTcF analysis based on Phase I data](https://pharmetheus.com/publications/risks-encountered-when-not-adjusting-for-diurnal-variation-and-food-effect-in-qtcf-analysis-based-on-phase-i-data/) - [Prediction of Monoclonal Antibodies Pharmacokinetics in Human: Identification of a Reference Neonatal Fc Receptor (FcRn) Binding Affinity Using Physiologically Based Pharmacokinetic (PBPK) Modeling](https://pharmetheus.com/publications/prediction-of-monoclonal-antibodies-pharmacokinetics-in-human-identification-of-a-reference-neonatal-fc-receptor-fcrn-binding-affinity-using-physiologically-based-pharmacokinetic-pbpk-modeling/) - [Physiologically based predictions of monoclonal antibody pharmacokinetics: insights from a large-scale data analysis](https://pharmetheus.com/publications/physiologically-based-predictions-of-monoclonal-antibody-pharmacokinetics-insights-from-a-large-scale-data-analysis/) - [Development of a PBPK model to predict monoclonal antibody pharmacokinetics and bioavailability following subcutaneous administration](https://pharmetheus.com/publications/development-of-a-pbpk-model-to-predict-monoclonal-antibody-pharmacokinetics-and-bioavailability-following-subcutaneous-administration/) - [Population Pharmacokinetics and Exposure‐Response Model‐Based Bayesian Extrapolation of FVC‐Based Efficacy Endpoints From Adults to Pediatric Patients Receiving Nintedanib](https://pharmetheus.com/publications/population-pharmacokinetics-and-exposure-response-model-based-bayesian-extrapolation-of-fvc-based-efficacy-endpoints-from-adults-to-pediatric-patients-receiving-ni/) - [Exposure-Efficacy Meta-model of Nintedanib in Adult Patients with Chronic Fibrosing Interstitial Lung Diseases](https://pharmetheus.com/publications/exposure-efficacy-meta-model-of-nintedanib-in-adult-patients-with-chronic-fibrosing-interstitial-lung-diseases/) - [Modernizing Preclinical Drug Development: The Role of New Approach Methodologies](https://pharmetheus.com/publications/modernizing-preclinical-drug-development-the-role-of-new-approach-methodologies/) - QSP, MIDD, Regulatory interactions, Preclinical, Phase I - [Regulatory Aspects of Sex-Related Differences in Drug Development: Past, Present, and Future](https://pharmetheus.com/publications/regulatory-aspects-of-sex-related-differences-in-drug-development-past-present-and-future/) - [Exposure-response analysis for time-to-event data in the presence of adaptive dosing: efficient approaches and pitfalls](https://pharmetheus.com/publications/exposure-response-analysis-for-time-to-event-data-in-the-presence-of-adaptive-dosing-efficient-approaches-and-pitfalls/) - [Exposure-response analysis for time-to-event data in the presence of adaptive dosing: efficient approaches and pitfalls (Poster)](https://pharmetheus.com/publications/exposure-response-analysis-for-time-to-event-data-in-the-presence-of-adaptive-dosing-efficient-approaches-and-pitfalls-poster-2/) - [Paediatric pharmacokinetic-pharmacodynamic extrapolation to identify suitable bulevirtide doses for children and adolescents with chronic hepatitis delta](https://pharmetheus.com/publications/paediatric-pharmacokinetic-pharmacodynamic-extrapolation-to-identify-suitable-bulevirtide-doses-for-children-and-adolescents-with-chronic-hepatitis-delta/) - [Integrated modeling of biomarkers, survival and safety in clinical oncology drug development](https://pharmetheus.com/publications/integrated-modeling-of-biomarkers-survival-and-safety-in-clinical-oncology-drug-development/) - [Exposure-Overall Survival Analysis for Quizartinib in Newly Diagnosed Patients with FMS- Like Tyrosine Kinase 3-Internal-Tandem-Duplication-Positive Acute Myeloid Leukemia](https://pharmetheus.com/publications/exposure-overall-survival-analysis-for-quizartinib-in-newly-diagnosed-patients-with-fms-like-tyrosine-kinase-3-internal-tandem-duplication-positive-acute-myeloid-leukemia/) - [Simplifying the Communication of Covariate Effects from Pharmacometric Models – The Role of Unconditional Covariate Effects](https://pharmetheus.com/publications/simplifying-the-communication-of-covariate-effects-from-pharmacometric-models-the-role-of-unconditional-covariate-effects/) - [Harnessing Open-Source Solutions: Insights From the First Open Systems Pharmacology (OSP) Community Conference](https://pharmetheus.com/publications/harnessing-open-source-solutions-insights-from-the-first-open-systems-pharmacology-osp-community-conference/) - Key topics: Translation of in vitro measures into clinical pharmacokinetics using PBPK and PBBM PBPK modeling for special populations, particularly in obstetric populations - [The evolving role of in vitro - in vivo correlation in Model-Informed Drug Development: A multi-stakeholder perspective](https://pharmetheus.com/publications/the-evolving-role-of-in-vitro-in-vivo-correlation-in-model-informed-drug-development-a-multi-stakeholder-perspective/) - [Population Pharmacokinetic Analysis of Datopotamab Deruxtecan (Dato-DXd), a TROP2-Directed Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors](https://pharmetheus.com/publications/population-pharmacokinetic-analysis-of-datopotamab-deruxtecan-dato-dxd-a-trop2-directed-antibody-drug-conjugate-in-patients-with-advanced-solid-tumors/) - [A joint ketamine and esketamine exposure-response model of MADRS score in major depressive disorder to enable informed trial design for candidate drugs with similar mode of action](https://pharmetheus.com/publications/a-joint-ketamine-and-esketamine-exposure-response-model-of-madrs-score-in-major-depressive-disorder-to-enable-informed-trial-design-for-candidate-drugs-with-similar-mode-of-action/) - [Population Pharmacokinetics (PopPK) of Quizartinib and Its Active Metabolite AC886 in Patients (Pts) With Newly Diagnosed (ND) Acute Myeloid Leukemia (AML)](https://pharmetheus.com/publications/population-pharmacokinetics-poppk-of-quizartinib-and-its-active-metabolite-ac886-in-patients-pts-with-newly-diagnosed-nd-acute-myeloid-leukemia-aml/) - [An Open-Source Framework for Virtual Bioequivalence Modeling and Clinical Trial Design](https://pharmetheus.com/publications/an-open-source-framework-for-virtual-bioequivalence-modeling-and-clinical-trial-design/) - [Pharmacometrics education for all by overcoming language barriers to enhance global collaboration](https://pharmetheus.com/publications/pharmacometrics-education-for-all-by-overcoming-language-barriers-to-enhance-global-collaboration/) - Offering pharmacometrics training in local languages — proven remarkably effective, allowing students to learn in French while building confidence in English. - [A Bayesian-NLME approach identifies patients at risk of delayed MTX elimination if informative TDM data is provided](https://pharmetheus.com/publications/a-bayesian-nlme-approach-identifies-patients-at-risk-of-delayed-mtx-elimination-if-informative-tdm-data-is-provided/) - [Development of efficient CAR-T cell clinical study designs: Towards understanding of novel anticancer therapies through optimal experimental design](https://pharmetheus.com/publications/development-of-efficient-car-t-cell-clinical-study-designs-towards-understanding-of-novel-anticancer-therapies-through-optimal-experimental-design/) - [Physiologically-based pharmacokinetic modeling to support submission of brigimadlin (BI 907828) in dedifferentiated liposarcoma](https://pharmetheus.com/publications/physiologically-based-pharmacokinetic-modeling-to-support-submission-of-brigimadlin-bi-907828-in-dedifferentiated-liposarcoma/) - [Exposure‐tumour growth inhibition modelling of brigimadlin using phase I solid tumour data to support phase II dose selection](https://pharmetheus.com/publications/exposure-tumour-growth-inhibition-modelling-of-brigimadlin-using-phase-i-solid-tumour-data-to-support-phase-ii-dose-selection/) - [A mathematical viral load model characterises the exposure- response relationship between bulevirtide and hepatitis delta virus and identifies the minimum duration of on-treatment viral load monitoring required for accurate prediction of long-term virologic response](https://pharmetheus.com/publications/a-mathematical-viral-load-model-characterises-the-exposure-response-relationship-between-bulevirtide-and-hepatitis-delta-virus-and-identifies-the-minimum-duration-of-on-treatment-viral-load-monitorin/) - [Model-informed drug development of a sustained release formulation of flucytosine in the treatment of cryptococcal meningitis: a case study using physiologically based pharmacokinetic modeling](https://pharmetheus.com/publications/model-informed-drug-development-of-flucytosine-sustained-release-formulation-in-the-treatment-of-cryptococcal-meningitis-a-case-study-using-pbpk-modeling/) - [A Physiologically Based Pharmacokinetic Model of Atorvastatin Acid Predicting CYP3A4 and OATP1B Drug–Drug Interactions](https://pharmetheus.com/publications/a-physiologically-based-pharmacokinetic-model-of-atorvastatin-acid-predicting-cyp3a4-and-oatp1b-drug-drug-interactions/) - [Development of a Physiologically-Based Pharmacokinetic Model for Coproporphyrin I (CP-I) Using the Open Systems Pharmacology Software Suite (PK-Sim and MoBi) for assessment of OATP1B-based DDIs](https://pharmetheus.com/publications/development-of-a-physiologically-based-pharmacokinetic-model-for-coproporphyrin-i-cp-i-using-the-open-systems-pharmacology-software-suite-pk-sim-and-mobi-for-assessment-of-oatp1b-based-ddis/) - [[2] A Physiologically-Based Pharmacokinetic (PBPK) Model Network for the Prediction of CYP1A2 and CYP2C19 Drug–Drug–Gene Interactions with Fluvoxamine, Omeprazole, S-mephenytoin, Moclobemide, Tizanidine, Mexiletine, Ethinylestradiol and Caffeine](https://pharmetheus.com/publications/a-physiologically-based-pharmacokinetic-pbpk-model-network-for-the-prediction-of-cyp1a2-and-cyp2c19-drug-drug-gene-interactions-with-fluvoxamine-omeprazole-s-mephenytoin-moclobemi-2/) - [[1] A Physiologically-Based Pharmacokinetic (PBPK) Model Network for the Prediction of CYP1A2 and CYP2C19 Drug-Drug-Gene Interactions with Fluvoxamine, Omeprazole, S-mephenytoin, Moclobemide, Tizanidine, Mexiletine, Ethinylestradiol, and Caffeine](https://pharmetheus.com/publications/a-physiologically-based-pharmacokinetic-pbpk-model-network-for-the-prediction-of-cyp1a2-and-cyp2c19-drug-drug-gene-interactions-with-fluvoxamine-omeprazole-s-mephenytoin-moclobemi-1/) - [The dawn of a new era: can machine learning and large language models reshape QSP modeling?](https://pharmetheus.com/publications/the-dawn-of-a-new-era-can-machine-learning-and-large-language-models-reshape-qsp-modeling/) - [The Reference-Corrected Visual Predictive Check: A More Intuitive Diagnostic for Non-Linear Mixed Effects Models](https://pharmetheus.com/publications/the-reference-corrected-visual-predictive-check-a-more-intuitive-diagnostic-for-non-linear-mixed-effects-models/) - [Application of model-informed drug development for dose optimization of brigimadlin in patients with dedifferentiated liposarcoma](https://pharmetheus.com/publications/application-of-model-informed-drug-development-for-dose-optimization-of-brigimadlin-in-patients-with-dedifferentiated-liposarcoma/) - [Optimizing infusion rates for N,N-dimethyltryptamine based on either a continuous variable model or a bounded integer model](https://pharmetheus.com/publications/page-2023-drug-disease-modelling-cns/) - [Expediting MIDD evidence generation to support quizartinib approval in newly diagnosed AML patients](https://pharmetheus.com/publications/expediting-midd-evidence-generation-to-support-quizartinib-approval-in-newly-diagnosed-aml-patients/) - [Pharmacokinetic-target engagement modelling of an anti-CCL17 monoclonal antibody in healthy volunteers and osteoarthritis patients](https://pharmetheus.com/publications/pharmacokinetic-target-engagement-modelling-of-an-anti-ccl17-monoclonal-antibody-in-healthy-volunteers-and-osteoarthritis-patients/) - [Population PKTE analysis of ocular and systemic data for intravitreal BI 764524 in patients with diabetic macular ischemia from the HORNBILL study](https://pharmetheus.com/publications/population-pkte-analysis-of-ocular-and-systemic-data-for-intravitreal-bi-764524-in-patients-with-diabetic-macular-ischemia-from-the-hornbill-study/) - [Assessment of Phase 1 pharmacokinetic-pharmacodynamic predictions, based on Phase 3 clinical trials results. Depemokimab pharmacokinetics and response in blood eosinophil count reduction for asthma and chronic rhinosinusitis with nasal polyps patients](https://pharmetheus.com/publications/assessment-of-phase-1-pharmacokinetic-pharmacodynamic-predictions-based-on-phase-3-clinical-trials-results-depemokimab-pharmacokinetics-and-response-in-blood-eosinophil-count-reduction-for-asthma-an/) - [Using Full Random Effects Models (FREM) in different software](https://pharmetheus.com/publications/using-full-random-effects-models-frem-in-different-software/) - [Predictive Probability of Success (PPOS) in longitudinal endpoint to predict trial outcome: What can we learn from a retrospective interim analysis?](https://pharmetheus.com/publications/predictive-probability-of-success-ppos-in-longitudinal-endpoint-to-predict-trial-outcome-what-can-we-learn-from-a-retrospective-interim-analysis/) - [Current State and New Horizons in Applications of Physiologically Based Biopharmaceutics Modeling (PBBM): A Workshop Report](https://pharmetheus.com/publications/current-state-and-new-horizons-in-applications-of-physiologically-based-biopharmaceutics-modeling-pbbm-a-workshop-report/) - [Model-informed drug development of autologous CAR-T cell therapy: Strategies to optimize CAR-T cell exposure leveraging cell kinetic/dynamic modeling](https://pharmetheus.com/publications/model-informed-drug-development-of-autologous-car-t-cell-therapy-strategies-to-optimize-car-t-cell-exposure-leveraging-cell-kinetic-dynamic-modeling/) - [A platform for mechanistic modelling of subcutaneous administration with the effect of immunogenicity within the Open Systems Pharmacology framework](https://pharmetheus.com/publications/a-platform-for-mechanistic-modelling-of-subcutaneous-administration-with-the-effect-of-immunogenicity-within-the-open-systems-pharmacology-framework/) - [The impact of misspecified covariate models on inclusion and omission bias when using fixed effects and full random effects models](https://pharmetheus.com/publications/the-impact-of-misspecified-covariate-models-on-inclusion-and-omission-bias-when-using-fixed-effects-and-full-random-effects-models/) - [Population pharmacokinetic analysis of Datopotamab deruxtecan (Dato-DXd), a TROP2-targeting antibody-drug conjugate](https://pharmetheus.com/publications/population-pharmacokinetic-analysis-of-datopotamab-deruxtecan-dato-dxd-a-trop2-targeting-antibody-drug-conjugate/) - [Mechanistic modelling of bioavailability and local immunogenicity after subcutaneous administration within the Open Systems Pharmacology framework](https://pharmetheus.com/publications/mechanistic-modelling-of-bioavailability-and-local-immunogenicity-after-subcutaneous-administration-within-the-open-systems-pharmacology-framework/) - [Use of quantitative systems pharmacology pipelines to bridge in vitro and in vivo results in drug discovery](https://pharmetheus.com/publications/use-of-quantitative-systems-pharmacology-pipelines-to-bridge-in-vitro-and-in-vivo-results-in-drug-discovery/) - [Absorption, Bioavailability, and Immunogenicity after Subcutaneous Administration: Evaluation of a Subcutaneous Platform within the Open Systems Pharmacology framework](https://pharmetheus.com/publications/absorption-bioavailability-and-immunogenicity-after-subcutaneous-administration-evaluation-of-a-subcutaneous-platform-within-the-open-systems-pharmacology-framework/) - [Rituximab PK and PD evaluation based on a study in diffuse large B-cell lymphoma: influence of tumor size on PK and assessment of PK similarity](https://pharmetheus.com/publications/rituximab-pk-and-pd-evaluation-based-on-a-study-in-diffuse-large-b-cell-lymphoma-influence-of-tumor-size-on-pk-and-assessment-of-pk-similarity/) - [A tutorial on pharmacometric Markov models](https://pharmetheus.com/publications/a-tutorial-on-pharmacometric-markov-models/) - [Optimizing Formulations for Treatment of Cryptococcal Meningoencephalitis in Sub-Saharan HIV Patients: Insights from PBPK Modeling](https://pharmetheus.com/publications/optimizing-formulations-for-treatment-of-cryptococcal-meningoencephalitis-in-sub-saharan-hiv-patients-insights-from-pbpk-modeling/) - [Concentration-QTcF analysis of quizartinib in patients with newly diagnosed FLT3-internal-tandem-duplication-positive acute myeloid leukemia](https://pharmetheus.com/publications/concentration-qtcf-analysis-of-quizartinib-in-patients-with-newly-diagnosed-flt3-internal-tandem-duplication-positive-acute-myeloid-leukemia/) - [Population pharmacokinetic analysis of quizartinib in patients with newly diagnosed FLT3-internal-tandem-duplication-positive acute myeloid leukemia](https://pharmetheus.com/publications/population-pharmacokinetic-analysis-of-quizartinib-in-patients-with-newly-diagnosed-flt3-internal-tandem-duplication-positive-acute-myeloid-leukemia/) - [The impact of misspecified covariate models on inclusion and omission bias when using FREM and FFEM](https://pharmetheus.com/publications/the-impact-of-misspecified-covariate-models-on-inclusion-and-omission-bias-when-using-frem-and-ffem/) - [A novel model for Platelets Dynamics: a pragmatic systems approach to characterize thrombocytopenia across multiple compounds and drug classes](https://pharmetheus.com/publications/a-novel-model-for-platelets-dynamics-a-pragmatic-systems-approach-to-characterize-thrombocytopenia-across-multiple-compounds-and-drug-classes/) - [Exposure-efficacy analysis of datopotamab deruxtecan (Dato-DXd), a TROP2-directed antibody-drug conjugate, in patients with advanced non-small cell lung cancer](https://pharmetheus.com/publications/exposure-efficacy-analysis-of-datopotamab-deruxtecan-dato-dxd-a-trop2-directed-antibody-drug-conjugate-in-patients-with-advanced-non-small-cell-lung-cancer/) - [Phase 1 interim population PK/PD modeling and recommended phase 2 dose exploration for IMM-1-104: A novel concept oral deep cyclic inhibitor of MEK](https://pharmetheus.com/publications/phase-1-interim-population-pk-pd-modeling-and-recommended-phase-2-dose-exploration-for-imm-1-104-a-novel-concept-oral-deep-cyclic-inhibitor-of-mek/) - 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[Model Based Support to Biosimilarity Assessment Planning – A Case Study of Pegfilgrastim](https://pharmetheus.com/publications/model-based-support-to-biosimilarity-assessment-planning-a-case-study-of-pegfilgrastim/) - [Sensitivity of Pegfilgrastim Pharmacokinetic and Pharmacodynamic Parameters to Product Differences in Similarity Studies](https://pharmetheus.com/publications/sensitivity-of-pegfilgrastim-pharmacokinetic-and-pharmacodynamic-parameters-to-product-differences-in-similarity-studies/) - [Dissolution and Translational Modeling Strategies Toward Establishing an In Vitro-In Vivo Link-a Workshop Summary Report](https://pharmetheus.com/publications/dissolution-and-translational-modeling-strategies-toward-establishing-an-in-vitro-in-vivo-link-a-workshop-summary-report/) - [Assessment of Expected Drug Exposure Relative Maximum Safety Limits in Early Phase Studies](https://pharmetheus.com/publications/assessment-of-expected-drug-exposure-relative-maximum-safety-limits-in-early-phase-studies/) - [A PK/PD Analysis of Circulating Biomarkers and Their Relationship to Tumor Response in Atezolizumab-Treated non-small Cell Lung Cancer Patients](https://pharmetheus.com/publications/a-pk-pd-analysis-of-circulating-biomarkers-and-their-relationship-to-tumor-response-in-atezolizumab-treated-non-small-cell-lung-cancer-patients/) - [Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report](https://pharmetheus.com/publications/applications-of-clinically-relevant-dissolution-testing-workshop-summary-report/) - [The Standard Output: A Tool-Agnostic Modeling Storage Format](https://pharmetheus.com/publications/the-standard-output-a-tool-agnostic-modeling-storage-format/) - [PharmTeX: a LaTeX-Based Open-Source Platform for Automated Reporting Workflow](https://pharmetheus.com/publications/pharmtex-a-latex-based-open-source-platform-for-automated-reporting-workflow/) - [Increasing the Efficiency of the Covariate Search Algorithm in the SCM](https://pharmetheus.com/publications/increasing-the-efficiency-of-the-covariate-search-algorithm-in-the-scm/) - [Artemether-Lumefantrine Dosing for Malaria Treatment in Young Children and Pregnant Women: A Pharmacokinetic-Pharmacodynamic Meta-Analysis](https://pharmetheus.com/publications/artemether-lumefantrine-dosing-for-malaria-treatment-in-young-children-and-pregnant-women-a-pharmacokinetic-pharmacodynamic-meta-analysis/) - [Practical Considerations for Using the Full Random Effects Modeling (FREM) Approach to Covariate Modeling](https://pharmetheus.com/publications/practical-considerations-for-using-the-full-random-effects-modeling-frem-approach-to-covariate-modeling/) - [A Population Pharmacokinetic-Pharmacodynamic Model of Pegfilgrastim](https://pharmetheus.com/publications/a-population-pharmacokinetic-pharmacodynamic-model-of-pegfilgrastim/) - [Dosing and Switching Strategies for Paliperidone Palmitate 3-Month Formulation in Patients with Schizophrenia Based on Population Pharmacokinetic Modeling and Simulation, and Clinical Trial Data](https://pharmetheus.com/publications/dosing-and-switching-strategies-for-paliperidone-palmitate-3-month-formulation-in-patients-with-schizophrenia-based-on-population-pharmacokinetic-modeling-and-simulation-and-clinical-trial-data/) - [Population Pharmacokinetics of a Novel Once-Every 3 Months Intramuscular Formulation of Paliperidone Palmitate in Patients with Schizophrenia](https://pharmetheus.com/publications/population-pharmacokinetics-of-a-novel-once-every-3-months-intramuscular-formulation-of-paliperidone-palmitate-in-patients-with-schizophrenia/) - [Model Evaluation of Continuous Data Pharmacometric Models: Metrics and Graphics](https://pharmetheus.com/publications/model-evaluation-of-continuous-data-pharmacometric-models-metrics-and-graphics/) - [A Regulatory View on Dose Finding Studies and on the Value of Dose-Exposure-Response Analysis](https://pharmetheus.com/publications/a-regulatory-view-on-dose-finding-studies-and-on-the-value-of-dose-exposure-response-analysis/) - [An Automated Sampling Importance Resampling Procedure for Estimating Parameter Uncertainty [2]](https://pharmetheus.com/publications/an-automated-sampling-importance-resampling-procedure-for-estimating-parameter-uncertainty-2/) - [Open Innovation: Towards Sharing of Data, Models and Workflows](https://pharmetheus.com/publications/open-innovation-towards-sharing-of-data-models-and-workflows/) - [An Automated Sampling Importance Resampling Procedure for Estimating Parameter Uncertainty](https://pharmetheus.com/publications/an-automated-sampling-importance-resampling-procedure-for-estimating-parameter-uncertainty/) - [Reproducible Reporting](https://pharmetheus.com/publications/reproducible-reporting/) - [Application of a Multi-Criteria Decision Analysis Model in the Dose Selection of Combination Therapy for Overactive Bladder](https://pharmetheus.com/publications/application-of-a-multi-criteria-decision-analysis-model-in-the-dose-selection-of-combination-therapy-for-overactive-bladder/) - [Determinants for Physical Growth Patterns in Low- and Middle-Income Countries](https://pharmetheus.com/publications/determinants-for-physical-growth-patterns-in-low-and-middle-income-countries/) - [Population Pharmacokinetic Simulations of Two Paliperidone Palmitate Formulations](https://pharmetheus.com/publications/population-pharmacokinetic-simulations-of-two-paliperidone-palmitate-formulations/) - [Using Item Response Theory to Yield Information from the MDS-UPDRS Items in Parkinson’s Disease Clinical Trials](https://pharmetheus.com/publications/using-item-response-theory-to-yield-information-from-the-mds-updrs-items-in-parkinsons-disease-clinical-trials/) - [Population Pharmacokinetic (PPK) Modeling of Vilazodone in Adolescent Patients with Major Depressive Disorder (MDD)](https://pharmetheus.com/publications/population-pharmacokinetic-ppk-modeling-of-vilazodone-in-adolescent-patients-with-major-depressive-disorder-mdd/) - [PKPD Modeling of Vilazodone (VLZ) in Adult Patients with Generalized Anxiety Disorder (GAD)](https://pharmetheus.com/publications/pkpd-modeling-of-vilazodone-vlz-in-adult-patients-with-generalized-anxiety-disorder-gad/) - [Population Pharmacokinetic Modeling of Paliperidone Palmitate 3-Month Formulation](https://pharmetheus.com/publications/population-pharmacokinetic-modeling-of-paliperidone-palmitate-3-month-formulation/) - [Modeling and Simulation of Count Data](https://pharmetheus.com/publications/modeling-and-simulation-of-count-data/) - [A Population PKPD Model for Changes in Sexual Function Questionnaire (CSFQ) in Patients with Major Depressive Disorder (MDD) Treated with Vilazodone or Placebo](https://pharmetheus.com/publications/a-population-pkpd-model-for-changes-in-sexual-function-questionnaire-csfq-in-patients-with-major-depressive-disorder-mdd-treated-with-vilazodone-or-placebo/) - [Reproducible Pharmacometrics](https://pharmetheus.com/publications/reproducible-pharmacometrics/) - [Contrast Enhancement in Bladder Tumors Examined with CT Urography Using Traditional Scan Phases](https://pharmetheus.com/publications/contrast-enhancement-in-bladder-tumors-examined-with-ct-urography-using-traditional-scan-phases/) ## Cases - [Crovalimab dose justification based on Phase 3 data in paroxysomal nocturnal hemoglobinurea patients](https://pharmetheus.com/cases/crovalimab-dose-justification/) - The main question was: Do the pharmacokinetic (PK) and drug exposure-response characterization of the observed Phase 3 data support the proposed weight-based two-tiered crovalimab dosing approach for the treatment of adult and adolescent patients with PNH not currently treated with complement inhibitors? - [Optimizing CAR-T cell exposure](https://pharmetheus.com/cases/optimizing-car-t-cell-exposure/) - CAR-T cell therapy is a novel therapeutic modality with unique kinetic and dynamic properties. Clear dose-exposure relationships do not seem to exist for any of the currently approved CAR-T cell products. Dose increases have not led to a commensurate increase in the measurable in vivo frequency of transferred CAR-T cells. Model-informed drug development approaches can, through enabling studies and program design choices, be an important contributor to alternative approaches beyond dose titration to optimize CAR-T cell therapy. - [Developing new formulations guided by a MIDD program - integrating PBPK-PBBM](https://pharmetheus.com/cases/midd-pbpk-formulation-development/) - How MIDD strategy integrating PBPK-PBBM modeling accelerates formulation development. Explore our case study on developing a new flucytosine formulation. - [PBPK-informed design of formulation prototype in the context of a sustained release formulation development](https://pharmetheus.com/cases/pbpk-informed-design-of-formulation-prototype-in-the-context-of-a-sustained-release-formulation-development/) - Pharmetheus was responsible for the MIDD strategy and the PBPK modeling and simulation. - [Disease effect prediction on PK in the context of a switch from an immediate release to a sustained release formulation.](https://pharmetheus.com/cases/disease-effect-prediction-on-pk-in-the-context-of-a-switch-from-an-immediate-release-to-a-sustained-release-formulation/) - In this PBPK-informed case study, we aim to support the clinical phase 2 protocol by investigating the disease impact on flucytosine (5FC) PK profile after administration of a Sustained Release (SR) formulation in the context of a switch from Immediate Release (IR) to (SR, for cryptococcal meningitis treatment in HIV patients. - [PBPK-informed selection of formulation prototype and dosage in the context of a sustained release formulation development](https://pharmetheus.com/cases/pbpk-informed-selection-of-formulation-prototype-and-dosage-in-the-context-of-a-sustained-release-formulation-development/) - In this PBPK-informed case study, we support the selection of a sustained release (SR) formulation prototype and optimal dosage for flucytosine (5FC) in HIV patients with cryptococcal meningitis by refining the legacy model , solely built with literature data, in integrating the first clinical PK data with the SR formulation prototypes of 5-FC. - [Food effect prediction and dose selection, using PBPK/PBBM, in the context of a switch from an immediate release to a sustained release formulation](https://pharmetheus.com/cases/food-effect-prediction-and-dose-selection-using-pbpk-pbbm-in-the-context-of-a-switch-from-an-immediate-release-to-a-sustained-release-formulation/) - In this Phase I case study, we harness Physiologically-Based Pharmacokinetics (PBPK) and Physiologically-Based Biopharmaceutics modeling (PBBM) to predict the food effect on flucytosine (5FC) pharmacokinetics in the context of a switch from immediate release (IR) to sustained release (SR) in HIV patients with cryptococcal meningitis. - [Model-informed microarray patches design for anti-retroviral drugs to treat children with HIV](https://pharmetheus.com/cases/microarray-patches-children-hiv/) - The main questions to address in this collaboration were regarding the patch size and the dosing regimen to select for 4 different anti-retroviral drugs. The context was a feasibility project for developing model-informed microarray patches (MAP) for anti-retroviral drugs to treat children with HIV and eventually support drug selection. ## Science & Services - [Quantitative Systems Pharmacology (QSP) consulting services](https://pharmetheus.com/science-and-services/pharmetheus-platforms/qsp/) - Don't commit to expensive, heavy-weight and closed licensed tools. Our QSP platform rapidly identify your specific situation and help extract maximum value. - [Concentration-QTc (C-QTc) modeling](https://pharmetheus.com/science-and-services/specific-services/c-qtc-modeling-services/) - Accelerate your cardiac safety strategy: We help clients replace traditional thorough QT (TQT) studies with robust concentration-QTc (C-QTc) modeling. - [Workshop catalog](https://pharmetheus.com/science-and-services/solutions/training-workshops/workshop-catalog/) - Looking to advance your team’s expertise and maximize your project outcomes? Our expert-led workshops provide the practical, high-impact training your organization needs to tackle technical challenges and stay ahead in quantitative sciences. - [Training workshops](https://pharmetheus.com/science-and-services/solutions/training-workshops/) - Sharpen your team's skills and knowledge with expert training. - [Data-driven strategies for pediatric success](https://pharmetheus.com/science-and-services/specific-services/pediatric-success-data-driven-strategies/) - PopPK & PKPD, PBPK & QSP, and Clinical Trial Simulations to translate existing adult data and prior knowledge into precise pediatric strategies. - [Accelerated submission: from database lock to submission-ready in record time](https://pharmetheus.com/science-and-services/specific-services/accelerated-submission-services/) - We partner with your clinical pharmacology and pharmacometrics teams to de-risk and accelerate NDA, BLA, and MAA submissions across the full submission pathway - [Model-Informed Bioequivalence & Biosimilarity Success](https://pharmetheus.com/science-and-services/specific-services/model-informed-bioequivalence-biosimilarity/) - De-risk complex drug development with model-informed bioequivalence and biosimilarity. Accelerate approval for generics, LAIs, and HVDs with MBBE and vBE. - [Contexts of use](https://pharmetheus.com/science-and-services/context-of-use/) - From trial design to scientific reporting and regulatory interactions, a drug development program will present itself through several contexts of use. - [Special/specific populations](https://pharmetheus.com/science-and-services/context-of-use/special-populations/) - Some populations, like pediatrics, patients with renal impairment, obese patients or others, require special attention and often dedicated trials. - [Pharmetheus Platforms](https://pharmetheus.com/science-and-services/pharmetheus-platforms/) - Harness the power of data integration to support decision-making and achieve predictions beyond observations. Explore the different Pharmetheus Platforms established for this purpose. - [Workshop: Forest plots in practical use - implementation and interpretation](https://pharmetheus.com/science-and-services/solutions/training-workshops/workshop-forest-plots-in-practical-use-implementation-and-interpretation/) - Forest plots are essential for visualizing model outputs in pharmacometric analysis. This workshop provides hands-on training in creating and interpreting Forest plots using R, NONMEM, and PsN. - [Case studies](https://pharmetheus.com/science-and-services/case-studies/) - Our case studies showcase our work within all phases of drug development. Each case clearly states the challenges and customer needs, and the services and solutions we provided. - [PBPK & PBBM consulting services](https://pharmetheus.com/science-and-services/pharmetheus-platforms/pbpk-pbbm/) - Physiologically-based pharmacokinetics (PBPK) and physiologically-based biopharmaceutics modeling (PBBM) leverage accumulated knowledge to inform mechanistic analyses and achieve predictions beyond direct observations. These models integrate physiological and drug-specific parameters to optimize drug development, refine dosing strategies, and enhance risk assessment. - [Model-Informed Drug Development (MIDD) consulting services](https://pharmetheus.com/science-and-services/pharmetheus-platforms/model-informed-drug-development/) - Our passion: Model-Informed Drug Development (MIDD) is at the heart of what we do at Pharmetheus. - [Special considerations](https://pharmetheus.com/science-and-services/context-of-use/special-considerations/) - C-QTc, DDIs, IVIVC, BE and BS, immunogenicity and other special considerations require special knowledge and methods, but have all in common to be able to be elucidated by leveraging modeling capabilities. - [Regulatory interactions](https://pharmetheus.com/science-and-services/context-of-use/regulatory-interactions/) - Navigate pharma regulatory affairs with confidence. Comprehensive support for timely interactions, reducing uncertainty for your NDA/BLA with global regulators. - [Pharmacometrics consulting services](https://pharmetheus.com/science-and-services/pharmetheus-platforms/pharmacometrics/) - Accelerate all phases of drug development. Pharmetheus provides expert modeling, simulation, and strategic guidance. - [Trial design and analyses](https://pharmetheus.com/science-and-services/context-of-use/trial-design-and-analysis/) - Every trial has its challenges, and we stand ready to complement teams’ capabilities to overcome them. We understand clinical trial demands and can support identifying vital questions and conduct the right analysis, while effectively communicating the results necessary to facilitate the decision-making process and progress the drug development program. - [Workshop: PBPK absorption modeling with the OSP Suite (PK-Sim®, MoBi®)](https://pharmetheus.com/science-and-services/solutions/training-workshops/workshop-physiologically-based-absorption-modeling-with-the-osp-suite-pk-sim-mobi/) - Physiologically-based pharmacokinetic (PBPK) absorption modeling plays a crucial role in understanding how drugs are absorbed through various routes of administration. This workshop provides hands-on training in using PK-Sim® and MoBi® to model absorption for oral, subcutaneous, lung, dermal, and ocular administration. - [Specific services](https://pharmetheus.com/science-and-services/specific-services/) - [Workshop: (R)TTE modeling - theory and NONMEM implementation](https://pharmetheus.com/science-and-services/solutions/training-workshops/workshop-rtte-modeling-theory-and-nonmem-implementation/) - This workshop provides hands-on training in TTE and RTTE modeling using NONMEM, focusing on survival analysis, event timing in clinical trials, exposure-response relationships, and simulation frameworks for informed drug development. - [Workshop: PBPK/PD-QSP](https://pharmetheus.com/science-and-services/solutions/training-workshops/workshop-pbpkpd-qsp/) - This workshop offers hands-on training in Physiologically-based pharmacokinetic (PBPK) modeling with PK-Sim® and MoBi®, focusing on integrating PD and QSP for complex DDIs and special populations like pediatrics and the elderly. - [Workshop: PBPK modeling for FIH & DDI with OSP Suite](https://pharmetheus.com/science-and-services/solutions/training-workshops/workshop-pbpk-modeling-for-first-in-human-ddi-with-osp-suite/) - Physiologically-Based Pharmacokinetic (PBPK) modeling is a cornerstone of translational drug development, supporting First-in-Human (FIH) dose selection and Drug-Drug Interaction (DDI) risk assessment. This workshop offers hands-on training in PBPK modeling using the OSP Suite tools PK-Sim and MoBi (version 12), with practical applications to nonclinical and clinical scenarios. - [Workshop: Leveraging in vitro data within PBPK](https://pharmetheus.com/science-and-services/solutions/training-workshops/workshop-leveraging-in-vitro-data-within-physiologically-based-pharmacokinetics/) - This workshop offers hands-on training in integrating in vitro data into Physiologically-Based Pharmacokinetic (PBPK) modeling for IVIVE and virtual bioequivalence trials. - [Workshop: Introduction to PK-Sim](https://pharmetheus.com/science-and-services/solutions/training-workshops/workshop-introduction-to-pk-sim/) - Physiologically-based pharmacokinetic (PBPK) modeling is a powerful approach in drug development. This workshop provides hands-on training in PBPK modeling using the Open Systems Pharmacology Suite (PK-Sim® & MoBi®). - [Workshop: Introduction to non-linear mixed effects modeling workshop](https://pharmetheus.com/science-and-services/solutions/training-workshops/workshop-introduction-to-non-linear-mixed-effects-modeling-workshop/) - This workshop provides an introduction to non-linear mixed effects modelling with lectures and hands-on exercises. - [Workshop: FREM in practical use - implementation and interpretation](https://pharmetheus.com/science-and-services/solutions/training-workshops/workshop-frem-in-practical-use-implementation-and-interpretation/) - This workshop provides theoretical insights and hands-on training (using R, NONMEM, and PsN) in applying the Full Random Effects Model (FREM) to integrate covariate data into your modeling process effectively for robust decision-making in pharmacometrics. - [Workshop: An introduction to probabilistic decisions support in drug development](https://pharmetheus.com/science-and-services/workshop-an-introduction-to-probabilistic-decisions-support-in-drug-development/) - Adequately framing probability concepts in drug development decision-making is key. This workshop provides theoretical insights on how Model-Informed Drug Development (MIDD) can be applied to facilitate probability-based decision-making in drug development. - [Workshop: Forest plots in practical use - implementation and interpretation](https://pharmetheus.com/science-and-services/solutions/training-workshops/workshop-forest-plots-in-practical-use-implementation-and-interpretation-2/) - Forest plots are essential for visualizing model outputs in pharmacometric analysis. This workshop provides hands-on training in creating and interpreting Forest plots using R, NONMEM, and PsN. - [Embedded Scientist](https://pharmetheus.com/science-and-services/solutions/embedded-scientist/) - Pharmetheus offers a unique Embedded Scientist service, offering vital expertise in quantitative approaches to support your projects. - [Milestone Analysis](https://pharmetheus.com/science-and-services/solutions/milestone-analysis/) - At Pharmetheus, we understand the importance of providing efficient and effective support to our clients. Our milestone analysis solutions are designed to meet the unique needs of each project. - [Solutions](https://pharmetheus.com/science-and-services/solutions/) - We are committed to providing tailored high-quality support to our clients. With expertise in model-informed drug development, pharmacometrics, and PBPK-QSP, we support with everything from strategy to design and analyses. - [Scientific Publication](https://pharmetheus.com/science-and-services/solutions/scientific-publication/) - Transforming technical reports into impactful publications. - [Expert Advice](https://pharmetheus.com/science-and-services/solutions/expert-advice/) - Learn from our experts at Pharmetheus for review work, strategy advice, and coaching. - [Program strategies and efficiencies](https://pharmetheus.com/science-and-services/context-of-use/program-strategies-and-efficiencies/) - Collaborations to support and inform strategies and decision-making. ## Careers - [Population modeling experts & PBPK and/or QSP modeling experts](https://pharmetheus.com/careers/open-positions/population-modeling-experts-and-pbpk-qsp-modeling-experts/) ## Categories - [Uncategorised](https://pharmetheus.com/news/category/uncategorised/) - [Event](https://pharmetheus.com/news/category/event/) - [People](https://pharmetheus.com/news/category/people/) - [Perspective](https://pharmetheus.com/news/category/perspective/) - [Company](https://pharmetheus.com/news/category/company/) - [CSR](https://pharmetheus.com/news/category/csr/) - [Career](https://pharmetheus.com/news/category/career/) ## Tags - [pharmacometrics](https://pharmetheus.com/news/tag/pharmacometrics/) - [students](https://pharmetheus.com/news/tag/students/) - [symposium](https://pharmetheus.com/news/tag/symposium/) - [modeling approaches](https://pharmetheus.com/news/tag/modeling-approaches/) - [MIDD](https://pharmetheus.com/news/tag/midd/) - [leadership team](https://pharmetheus.com/news/tag/leadership-team/) - [management team](https://pharmetheus.com/news/tag/management-team/) - [organization](https://pharmetheus.com/news/tag/organization/) - [organization development](https://pharmetheus.com/news/tag/organization-development/) - [expanding business](https://pharmetheus.com/news/tag/expanding-business/) - [growing team](https://pharmetheus.com/news/tag/growing-team/) - [model informed drug development](https://pharmetheus.com/news/tag/model-informed-drug-development/) - [corporate news](https://pharmetheus.com/news/tag/corporate-news/) - [company news](https://pharmetheus.com/news/tag/company-news/) - [research organization](https://pharmetheus.com/news/tag/research-organization/) - [scientists](https://pharmetheus.com/news/tag/scientists/) - [executive management](https://pharmetheus.com/news/tag/executive-management/) - [biotech](https://pharmetheus.com/news/tag/biotech/) - [biosimulation](https://pharmetheus.com/news/tag/biosimulation/) - [Treatment optimization](https://pharmetheus.com/news/tag/treatment-optimization/) - [clinical pharmacology](https://pharmetheus.com/news/tag/clinical-pharmacology/) - [quantative pharmacology system](https://pharmetheus.com/news/tag/quantative-pharmacology-system/) - [pharmacometrics consultants](https://pharmetheus.com/news/tag/pharmacometrics-consultants/) - [research and development](https://pharmetheus.com/news/tag/research-and-development/) - [scientific](https://pharmetheus.com/news/tag/scientific/) ## Publications Categories - [Pharmacometrics](https://pharmetheus.com/news/publications_category/pharmacometrics/) - [Trial design and analysis](https://pharmetheus.com/news/publications_category/trial-design-and-analysis/) - [Oncology](https://pharmetheus.com/news/publications_category/oncology/) - [Journal](https://pharmetheus.com/news/publications_category/journal/) - [Program strategies and efficiencies](https://pharmetheus.com/news/publications_category/program-strategies-and-efficiencies/) - [Special/specific populations](https://pharmetheus.com/news/publications_category/special-populations/) - [CV](https://pharmetheus.com/news/publications_category/cv/) - [Special considerations](https://pharmetheus.com/news/publications_category/special-considerations/) - [Regulatory interactions](https://pharmetheus.com/news/publications_category/regulatory-interactions/) - [Conference](https://pharmetheus.com/news/publications_category/conference/) - [CNS](https://pharmetheus.com/news/publications_category/cns/) - [MIDD](https://pharmetheus.com/news/publications_category/midd/) - [Other](https://pharmetheus.com/news/publications_category/other/) - [Hematology](https://pharmetheus.com/news/publications_category/hematology/) - [PBPK/PBBM](https://pharmetheus.com/news/publications_category/pbpk-pbbm/) - [Infectious diseases](https://pharmetheus.com/news/publications_category/infectious-diseases/) - [Immunology](https://pharmetheus.com/news/publications_category/immunology/) - [Respiratory](https://pharmetheus.com/news/publications_category/respiratory/) - [Automation](https://pharmetheus.com/news/publications_category/automation/) - [Methodology](https://pharmetheus.com/news/publications_category/methodology/) - [QSP](https://pharmetheus.com/news/publications_category/qsp/) - [Phase I](https://pharmetheus.com/news/publications_category/phase-i/) - [Phase II](https://pharmetheus.com/news/publications_category/phase-ii/) - [Phase III](https://pharmetheus.com/news/publications_category/phase-iii/) - [DDI](https://pharmetheus.com/news/publications_category/ddi/) - [Ophthalmology](https://pharmetheus.com/news/publications_category/ophthalmology/) - [Preclinical](https://pharmetheus.com/news/publications_category/preclinical/) - [Gastroenterology](https://pharmetheus.com/news/publications_category/gastroenterology/) - [Cardiovascular](https://pharmetheus.com/news/publications_category/cardiovascular/) - [Rheumatology](https://pharmetheus.com/news/publications_category/rheumatology/) - [Endocrinology](https://pharmetheus.com/news/publications_category/endocrinology/) - [Metabolism](https://pharmetheus.com/news/publications_category/metabolism/) - [Renal diseases](https://pharmetheus.com/news/publications_category/renal-diseases/) - [Obesity](https://pharmetheus.com/news/publications_category/obesity/) - [Genetic](https://pharmetheus.com/news/publications_category/genetic/) - [Pediatrics](https://pharmetheus.com/news/publications_category/pediatrics/)