Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK

descriptionPublicationkeyboard_double_arrow_right Article , Other literature type 01 Apr 2015 English Publisher:WileyJournal:CPT: Pharmacometrics & Systems Pharmacology, volume 4, pages 226-230 (issn: 2163-8306, eissn: 2163-8306,

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Authors: Wagner, C; Zhao, P; Pan, Y; Hsu, V; Grillo, J; Huang, SM; Sinha, V;

doi: 10.1002/psp4.33

pmid: 26225246

pmc: PMC4429576

Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK

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Abstract

The US Food and Drug Administration (FDA) public workshop, entitled “Application of Physiologically‐based Pharmacokinetic (PBPK) Modeling to Support Dose Selection focused on the role of PBPK in drug development and regulation. Representatives from industry, academia, and regulatory agencies discussed the issues within plenary and panel discussions. This report summarizes the discussions and provides current perspectives on the application of PBPK in different areas, including its utility, predictive performance, and reporting for regulatory submissions.

Related Organizations

United States Food and Drug Administration
United States
Center for Drug Evaluation and Research
United States

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