Advancing current PBPK model applications to support internal development and regulatory decisions

Authors: Le Merdy M
Conference: EUFEMED
Software: GastroPlus®
Division: Simulations Plus

Take home messages:
• Number of applications received by the U.S. FDA including PBPK models is exponentially rising since 2008
• The U.S. FDA is an advocate of the PBPK approach to waive some clinical trials
• The U.S. FDA is investing time and money to improve the confidence level for PBPK model

European Federation for Exploratory Medicines Development in Lyon, France May 15-17, 2019

By Maxime Le Merdy