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Publications

Below we provide links to posters, white papers and scientific publications by Pharmetheus affiliates in chronological order. Please note that access to some publications may require a subscription.

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Publications

03.06.25

Expediting MIDD evidence generation to support quizartinib approval in newly diagnosed AML patients

Phase III

Oncology

MIDD

Regulatory interactions

Program strategies and efficiencies

PAGE 33 (2025) Abstr 11445

Glatard A, Mezzalana E, Zheng M, Bergstrand M, Smania G

03.06.25

Model-based approach for a new Prolonged-Release (PR) formulation of ivabradine: PK and PKPD assessment to support bioequivalence

MIDD

Cardiovascular

Trial design and analysis

Regulatory interactions

Pharmacometrics

PAGE 33 (2025) Abstr 11678

Skerlep M, Mezzalana E, Chenel M, Gendrot N, Fouliard S

03.06.25

Physiologically-based pharmacokinetic modeling to support submission of brigimadlin (BI 907828) in dedifferentiated liposarcoma

Oncology

MIDD

Trial design and analysis

Regulatory interactions

Automation

PAGE 33 (2025) Abstr 11489

Kanacher T, Busse D, Sailer R, Sjögren E, Mezzalana E, Pellowe M, Chenel M, Gómez-Mantilla JD, Ince I.

03.06.25

Pharmacokinetic-target engagement modelling of an anti-CCL17 monoclonal antibody in healthy volunteers and osteoarthritis patients

Phase I

MIDD

Immunology

Trial design and analysis

Pharmacometrics

PAGE 33 (2025) Abstr 11611

Panoilia E, Chenel M, Siederer S

03.06.25

Population PKTE analysis of ocular and systemic data for intravitreal BI 764524 in patients with diabetic macular ischemia from the HORNBILL study

Phase I

Phase II

MIDD

Pharmacometrics

Ophthalmology

Program strategies and efficiencies

PAGE 33 (2025) Abstr 11604

Ooi QX, Yin AY, Krawczyk B, Gliem M, Brown D, Jhaveri C, Gonzalez VH, Wykoff C, Nassar K, Wölke S, Simons G, Wagner M, Sivaprasad S, Nguyen QD, Niebecker R

03.06.25

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

Phase I

Phase III

Pharmacometrics

Respiratory

PAGE 33 (2025) Abstr 11696

Tanneau L, Lavalley-Morelle A, Thorsted A, Gupta A, Schalkwijk S, Ribbing J

03.06.25

Using Full Random Effects Models (FREM) in different software

MIDD

Pharmacometrics

Methodology

PAGE 33 (2025) Abstr 11523

Yu GB, Langenhorst J, Nyberg J, Jonsson EN

03.06.25

Predictive Probability of Success (PPOS) in longitudinal endpoint to predict trial outcome: What can we learn from a retrospective interim analysis?

MIDD

Pharmacometrics

Methodology

PAGE 33 (2025) Abstr 11324

Anziano R, Henrich A, Kern S, Shafiq A, Jonsson EN

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