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

Overview
Journal CPT Pharmacometrics Syst Pharmacol
Publisher Wiley
Specialty Pharmacology
Date 2015 Jul 31
PMID 26225246
Citations 94
Authors
C Wagner
P Zhao
Y Pan
V Hsu
J Grillo
S M Huang
V Sinha
Affiliations
Soon will be listed here.
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.

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