Report from EMA Workshop on Qualification and Reporting of Physiologically‐based Pharmacokinetic (PBPK) Modelling and Simulation

Authors: Zhao P
Publication: CPT Pharmacometrics Syst Pharmacol
Keywords: biological models, computer simulation, humans, PBPK modeling, pharmaceutical preparations, pharmacokinetic
Software: GastroPlus®

Abstract

On Nov 21, 2016, the European Medicines Agency (EMA) hosted a workshop to discuss its draft guideline on qualification and reporting of physiologically based pharmacokinetic (PBPK) analysis.1 Published on July 21, 2016, the draft PBPK guideline is currently under the period of public comments.