Open AccessApplication of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK
Author(s) -
Wagner C,
Zhao P,
Pan Y,
Hsu V,
Grillo J,
Huang SM,
Sinha V
Publication year - 2015
Publication title -
cpt: pharmacometrics and systems pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 37
ISSN - 2163-8306
DOI - 10.1002/psp4.33
Subject(s) - physiologically based pharmacokinetic modelling , food and drug administration , pharmacokinetics , regulatory science , drug , pharmacology , management science , medicine , computer science , engineering , pathology
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.