Clinical Pharmacology – Chemical
PBPK or mechanistic models have been widely used at various stages of drug product development and regulatory review for different purposes, such as ADME predictions, DDI potential assessment, providing mechanistic explanation to PK characteristics, and PK predictions in special populations. This presentation will provide an overview of the utility of PBPK modeling and simulation in product development, optimization, and regulatory submissions. Areas where there is high confidence in model performance, and scientific challenges in low confidence areas will be discussed. An update on the PBPK submissions to the Office of Clinical Pharmacology, FDA will be provided. Case examples of PBPK model applications will be discussed to illustrate how PBPK modeling and simulation have been used for decision making from a clinical pharmacology perspective.