Chapter 11 - Examples of physiologically based pharmacokinetic modeling applied to risk assessment

Abstract

Physiologically based pharmacokinetic (PBPK) models are useful in risk assessment as a scientifically supportable way for conducting extrapolations, thereby reducing uncertainty. PBPK models’ applications in risk assessment include route-to-route extrapolation, extrapolation across exposure patterns, interspecies extrapolation, and comparing sensitive subpopulations to the general population. This chapter provides an overview of the basics of risk assessment, discusses an approach for how to evaluate PBPK models for potential use in risk assessment, and provides brief summaries of examples of modern applications of PBPK models in risk assessment.