Pharmetheus https://validator.w3.org/feed/docs/rss2.html Anna Mc Laughlin News Home Model-based Analysis with Mechanistic Insights to CAR-T Cell Therapy Kinetics: Case Study with Axicabtagene Ciloleucel and Brexucabtagene Autoleucel Events 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 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 Rock and roll – deliverables driven by standardized data specifications 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 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 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 Model-informed fixed dosing of rozanolixizumab in gMG: PK/PD advantages and comparison with other FcRn blockers Workshop: Learn and apply TTE and RTTE modeling with a focus on NONMEM 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 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 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 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 Integrating in silico epitope prediction and mechanistic QSP modeling for benchmarking immunogenicity risk The visual predictive check and real-world data 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 Population pharmacokinetics and pharmacodynamics of depemokimab in people with asthma and chronic rhinosinusitis with nasal polyps Richard Anziano Scientific advisors Workshop at ACoP 2026 – (R)TTE analysis: MIDD applications, concept, methodology and NONMEM hands-on Best Practices in Physiologically Based Pharmacokinetic (PBPK) Modeling An open-source PBBM integrating the particle drifting effect to predict human oral absorption of nanoparticle formulations Let’s connect: Pharmetheus’ 2026 conference calendar PBPK workflow for predicting clinical DDI risk of OATP1B1/3 inhibitors utilizing the CP-I biomarker: A case study with cyclosporine A Consultants Lina Keutzer Bram Agema Ulrika Wählby Hamrén Accelerating subcutaneous drug development: A mechanistic absorption model for the Open Systems Pharmacology framework Mission, vision & values Karam Alali shares his experience of Uppsala Pharmacometric Summer School Open-source PBPK modeling of artemether for pediatric extrapolations: integrating enzyme ontogeny, CYP2B6 auto-induction and malnutrition Pharmetheus at AAPS PharmSci 2026 A Longitudinal Disease Progression Model Characterizing Endoscopic Response and Remission in Crohn’s Disease Quantitative Systems Pharmacology (QSP) consulting services Jonas Möller Population pharmacokinetics and pharmacokinetics-pharmacodynamics analyses of elafibranor to support dose selection in primary biliary cholangitis