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. 2019 Jan;108(1):21-25.
doi: 10.1016/j.xphs.2018.10.033. Epub 2018 Oct 29.

Physiologically Based Pharmacokinetic Modeling in Regulatory Science: An Update From the U.S. Food and Drug Administration's Office of Clinical Pharmacology

Manuela Grimstein  1 , Yuching Yang  2 , Xinyuan Zhang  3 , Joseph Grillo  1 , Shiew-Mei Huang  1 , Issam Zineh  1 , Yaning Wang  1
Affiliations

Physiologically Based Pharmacokinetic Modeling in Regulatory Science: An Update From the U.S. Food and Drug Administration's Office of Clinical Pharmacology

Manuela Grimstein et al. J Pharm Sci. 2019 Jan.

Abstract

This commentary provides an update on the status of physiologically based pharmacokinetic modeling and simulation at the U.S. Food and Drug Administration's Office of Clinical Pharmacology. Limitations and knowledge gaps in integration of physiologically based pharmacokinetic approach to inform regulatory decision making, as well as the importance of scientific engagement with drug developers who intend to use this approach, are highlighted.

Keywords: clinical pharmacokinetics; drug-drug interaction(s); in silico modeling; physiologically based pharmacokinetic (PBPK) modeling; regulatory science.

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