Health AI Central
Peer-Reviewed Publication
CPT Pharmacometrics Syst Pharmacol2026;15(1):e70141.January 1, 2026Journal Article

Physiologically-Based Pharmacokinetic Modeling to Support Pediatric Clinical Development: An IQ Working Group Perspective on the Current Status and Challenges.

James W T Yates1, Michael Zientek2, Kunal S Taskar1, Wen Lin3, Tycho Heimbach4, Stefan Willmann5, Jessica Rehmel6, Neil Parrott7, Michael Hanley2, Justine Badee8, Yuan Chen9, Susan Cole10, Loeckie De Zwart11, Sebastian Haertter12, Rongrong Jiang13, Masakatsu Kotsuma14, Guiqing Liang15, Yu-Wei Lin16, Jing Liu17, Ying Ou18, Juliane Rascher12, Naveed A Shaik19, Jan Wahlstrom20, Xiaofeng Wang21, Guangqing Xiao22, Ka Lai Yee23, S Y Amy Cheung24
1DMPK, Preclinical Sciences, GSK, Stevenage, UK.
2Takeda Development Center Americas, Cambridge, Massachusetts, USA.
3Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. FDA, Silver Spring, Maryland, USA.
4Pharmaceutical Sciences and Clinical Supply, Merck & co., Inc., Rahway, New Jersey, USA.
5Bayer AG, Research & Development Pharmaceuticals, Pharmacometrics/Modeling & Simulation, Wuppertal, Germany.
6Global Pharmacokinetics, Pharmacodynamics, and Pharmacometrics, Eli Lilly and Company, Indianapolis, Indiana, USA.
7Pharmaceutical Sciences, Roche Pharma Research and Early Development, Roche Innovation Center Basel, Basel, Switzerland.
8PK Sciences, Biomedical Research. Novartis, Basel, Switzerland.
9Drug Metabolism and Pharmacokinetics, Genentech, Inc, South San Francisco, California, USA.
10Medicines & Healthcare Products Regulatory Agency, London, UK.
11Janssen Pharmaceutica NV, a Johnson & Johnson Company, Beerse, Belgium.
12Clinical Pharmacology, Boehringer Ingelheim Pharma, Ingelheim, Germany.
13Drug Metabolism and Pharmacokinetics, Eisai Inc., Cambridge, Massachusetts, USA.
14Quantitative Clinical Pharmacology, Daiichi Sankyo co., Ltd., Tokyo, Japan.
15Drug Metabolism and Pharmacokinetics, Vertex Pharmaceuticals, Inc., Boston, Massachusetts, USA.
16Infection Program and Department of Microbiology, Monash Biomedicine Discovery Institute, Monash University, Clayton, Victoria, Australia.
17Clinical Pharmacology, Pfizer Inc., Groton, Connecticut, USA.
18Clinical Pharmacology, Beigene, USA.
19Quantitative Pharmacology and Pharmacometrics (QP2), Merck & Co, San Francisco, California, USA.
20Pharmacokinetics and Drug Metabolism, Amgen, Inc., Thousand Oaks, California, USA.
21Relay Therapeutics Cambridge, Cambridge, Massachusetts, USA.
22DMPK, Revolution Medicines, Redwood City, California, USA.
23Quantitative Pharmacology and Pharmacometrics, Merck & co, Inc., Rahway, New Jersey, USA.
24Quantitative Science, Drug Development Solutions, Certara, Radnor, USA.
PubMed PMC DOI PDF

Abstract

Pediatric extrapolation strategies issued by health authorities have streamlined pediatric drug development and reduced the unnecessary burden of conducting pediatric clinical studies. In line with these strategies, physiologically based pharmacokinetic (PBPK) models have been utilized extensively for initial dosing regimen and sampling timepoint selection for pediatric studies, as well as dose va…

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