Andrea Edginton PhD, Michael Neely, MD (University of Southern California) and Joerg Lippert PhD (Bayer, Germany) receive a US FDA grant ($900,000 US 2018-2021) on PBPK and Population Modeling Seamlessly Linked to Clinical Trial Simulation in an Open-Source Software Platform.
The goal of this project is to develop a comprehensive, open-source software platform for bioequivalence (BE) study design. The platform will be the Open Systems Pharmacology Suite that includes PK-Sim and Mobi. Components of the platform will implement a framework for population modeling and parameter updating based on physiologically-based pharmacokinetic (PBPK) model structures and be integrated with a trial simulator. The selection of appropriate and substantiated BE study design will facilitate regulatory interpretation of sponsor claims and data from such a trial.