Enabling Efficient Drug Discovery and Development via Physiologically-based Pharmacokinetic (PBPK) Modeling | An ISSX 2021 Short Course

The focus of this course will include a review of what makes a PBPK model acceptable from a regulatory viewpoint, including best practices for qualifying and validating models.

Co-chairs: Ping Zhao, Bill and Melinda Gates Foundation, Seattle, Washington, USA and Manthena Varma, Pfizer Inc., Groton, Connecticut, USA

Introduction to PBPK Modeling
Amin Rostami-Hodjegan, University of Manchester and Certara, Manchester, United Kingdom

Current State in Predicting Enzyme-based Drug Disposition and Interaction Using PBPK
Ernesto Callegari, Pfizer Inc., Groton, Connecticut, USA

Quantitative Prediction of the Hepatic Clearance and Complex Drug Interactions using PBPK Modeling with in vitro Transporter/enzyme Data
Yuichi Sugiyama, RIKEN Innovation Center, Tokyo, Japan

PBPK Modeling in Special Populations
Maria Posada, Eli Lilly and Company, Indianapolis, Indiana, USA