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

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Title: Physiologically-Based Pharmacokinetic Modeling to Support Pediatric Clinical Development: An IQ Working Group Perspective on the Current Status and Challenges.
Authors: Yates JWT; DMPK, Preclinical Sciences, GSK, Stevenage, UK., Zientek M; Takeda Development Center Americas, Cambridge, Massachusetts, USA., Taskar KS; DMPK, Preclinical Sciences, GSK, Stevenage, UK., Lin W; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. FDA, Silver Spring, Maryland, USA., Heimbach T; Pharmaceutical Sciences and Clinical Supply, Merck & co., Inc., Rahway, New Jersey, USA., Willmann S; Bayer AG, Research & Development Pharmaceuticals, Pharmacometrics/Modeling & Simulation, Wuppertal, Germany., Rehmel J; Global Pharmacokinetics, Pharmacodynamics, and Pharmacometrics, Eli Lilly and Company, Indianapolis, Indiana, USA., Parrott N; Pharmaceutical Sciences, Roche Pharma Research and Early Development, Roche Innovation Center Basel, Basel, Switzerland., Hanley M; Takeda Development Center Americas, Cambridge, Massachusetts, USA., Badee J; PK Sciences, Biomedical Research. Novartis, Basel, Switzerland., Chen Y; Drug Metabolism and Pharmacokinetics, Genentech, Inc, South San Francisco, California, USA., Cole S; Medicines & Healthcare Products Regulatory Agency, London, UK., De Zwart L; Janssen Pharmaceutica NV, a Johnson & Johnson Company, Beerse, Belgium., Haertter S; Clinical Pharmacology, Boehringer Ingelheim Pharma, Ingelheim, Germany., Jiang R; Drug Metabolism and Pharmacokinetics, Eisai Inc., Cambridge, Massachusetts, USA., Kotsuma M; Quantitative Clinical Pharmacology, Daiichi Sankyo co., Ltd., Tokyo, Japan., Liang G; Drug Metabolism and Pharmacokinetics, Vertex Pharmaceuticals, Inc., Boston, Massachusetts, USA., Lin YW; Infection Program and Department of Microbiology, Monash Biomedicine Discovery Institute, Monash University, Clayton, Victoria, Australia., Liu J; Clinical Pharmacology, Pfizer Inc., Groton, Connecticut, USA., Ou Y; Clinical Pharmacology, Beigene, USA., Rascher J; Clinical Pharmacology, Boehringer Ingelheim Pharma, Ingelheim, Germany., Shaik NA; Quantitative Pharmacology and Pharmacometrics (QP2), Merck & Co, San Francisco, California, USA., Wahlstrom J; Pharmacokinetics and Drug Metabolism, Amgen, Inc., Thousand Oaks, California, USA., Wang X; Relay Therapeutics Cambridge, Cambridge, Massachusetts, USA., Xiao G; DMPK, Revolution Medicines, Redwood City, California, USA., Yee KL; Quantitative Pharmacology and Pharmacometrics, Merck & co, Inc., Rahway, New Jersey, USA., Cheung SYA; Quantitative Science, Drug Development Solutions, Certara, Radnor, USA.
Source: CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2026 Jan; Vol. 15 (1), pp. e70141. Date of Electronic Publication: 2025 Nov 18.
Publication Type: Journal Article; Review
Journal Info: Publisher: Wiley Country of Publication: United States NLM ID: 101580011 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2163-8306 (Electronic) Linking ISSN: 21638306 NLM ISO Abbreviation: CPT Pharmacometrics Syst Pharmacol Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Physiologically-Based Pharmacokinetic Modeling to Support Pediatric Clinical Development: An IQ Working Group Perspective on the Current Status and Challenges.
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