How to obtain biowaivers for clinical trials using PBPK models, two case studies

Authors: LeMerdy M
Conference: EUFEMED
Software: GastroPlus®
Division: Simulations Plus

Take home messages:
• FDA is open to proposals of using modeling approaches for bioequivalence (BE), or for new drugs,with the proper justification and model verification
• PBPK models can answer a variety of questions from regulatory agencies
• PBPK is a great tool to understand the interconnection between API properties, formulation attributes and human physiology

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

By Maxime Le Merdy