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Risks encountered when not adjusting for diurnal variation and food effect in QTcF analysis based on Phase I data

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Exposure-response analysis for time-to-event data in the presence of adaptive dosing: efficient approaches and pitfalls

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Population Pharmacokinetics and Exposure‐Response Model‐Based Bayesian Extrapolation of FVC‐Based Efficacy Endpoints From Adults to Pediatric Patients Receiving Nintedanib

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Publications 5 of 268

09.08.26

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

DDIJournalPBPK/PBBMProgram strategies and efficienciesRegulatory interactionsTrial design and analysis

Front. Pharmacol. 2026;17:1828033

Kanacher T, Pellowe M, Kovar C, Eriksson J, Wu J, Busse D, Gómez-Mantilla JD, Stopfer P, Ince I, Huang F.

30.07.26

Population pharmacokinetics and pharmacodynamics of depemokimab in people with asthma and chronic rhinosinusitis with nasal polyps

JournalMIDDPharmacometricsPhase IPhase IIIRegulatory interactionsRespiratoryTrial design and analysis

J Clin Pharmacol. 2026 Aug;66(8):e70187.

Thorsted A, Tanneau L, Lavalley-Morelle A, Follows R, Jacques L, Bird N, Gevaert P, Pavord I, Ribbing J, Gupta A, Howarth P, Schalkwijk S.

21.07.26

Model-based Analysis with Mechanistic Insights to CAR-T Cell Therapy Kinetics: Case Study with Axicabtagene Ciloleucel and Brexucabtagene Autoleucel

JournalMethodologyMIDDOncologyPharmacometricsProgram strategies and efficiencies

Clin Pharmacol Ther . 2026 Jul 21:10.1002/cpt.70395

Mc Laughlin AM, Bergstrand M, Ruiz-Garcia A, Filosto S, Shen R.

15.07.26

Best Practices in Physiologically Based Pharmacokinetic (PBPK) Modeling

JournalPBPK/PBBMRegulatory interactions

CPT: Pharmacometrics & Systems Pharmacology, 2026 July; 15(7)

Chenel M, Dallmann A, Ince I, Meyer M, Schlender JF, Teutonico D, Sjögren E.

25.06.26

Accelerating subcutaneous drug development: A mechanistic absorption model for the Open Systems Pharmacology framework

JournalMethodologyPBPK/PBBM

CPT Pharmacometrics Syst Pharmacol. 2026 Jul;15(7):e70292.

Pellowe M, Dubbelboer I, Sjögren E.

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