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Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision‐making—A workshop summary
Document Type
Academic Journal
Author
Jean, Daphney; Naik, Kunal; Milligan, Lauren; Hall, Stephen; Huang, Shiew Mei; Isoherranen, Nina; Kuemmel, Colleen; Seo, Paul; Tegenge, Million A.; Wang, Yaning; Yang, Yuching; Zhang, Xinyuan; Zhao, Liang; Zhao, Ping; Benjamin, Jessica; Bergman, Kimberly; Grillo, Joseph; Madabushi, Rajanikanth; Wu, Fang; Zhu, Hao; Zineh, Issam
Source
CPT: Pharmacometrics & Systems Pharmacology. November 2021, Vol. 10 Issue 11, p1271, 5 p.
Subject
United States. Food and Drug Administration -- Conferences, meetings and seminars
Conferences, meetings and seminars
Case studies
Pharmacology -- Conferences, meetings and seminars -- Case studies
Decision making -- Case studies -- Conferences, meetings and seminars
Nilotinib -- Case studies -- Conferences, meetings and seminars
Abemaciclib -- Conferences, meetings and seminars -- Case studies
Best practices -- Case studies -- Conferences, meetings and seminars
Decision-making -- Case studies -- Conferences, meetings and seminars
Language
English
Abstract
INTRODUCTION Model‐informed drug development (MIDD) tools including physiologically based pharmacokinetic (PBPK) modeling can improve the mechanistic understanding of a drug’s pharmacology and potentially translate into development efficiencies. This article summarizes [...]

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