CEC03-01 Introduction to PBPK modeling for exposure predictions

Abstract

This lecture will provide an introduction to the use of physiologically-based pharmacokinetic (PBPK) modeling as a tool to predict the pharmacokinetics of novel small molecule therapeutics in both humans and non-clinical safety species, such as animals. This modeling helps predict the anticipated therapeutic exposure/doses and the corresponding safety margins to enable decision-making before first-in-human trials. The lecture will cover an introductory component to the concept of PBPK, its usefulness in safety prediction, and provide examples of a step-by-step estimation of safety margins, which is common practice in the pharmaceutical industry.