Abstract
In this GastroPlus® webinar hosted by Principal Scientist Jim Mullin explores updated human exposure predictions and food effect risk identification using preclinical data and PBPK models. The objectives of this complimentary lecture are to:
(1) Discuss “best practices” in integrating in vitro and in vivo data to develop PBPK models and developing evidentiary criteria for PBPK models to be used to support regulatory decision-making
(2) Share case examples applying PBPK modeling and simulation that highlight the opportunities and limitations of this approach
(3) Discuss the knowledge gaps and research needs to advance PBPK modeling sciences in drug development and regulatory evaluation When models are established following the proposed workflow, we believe they can be used to simulate outcomes for new doses and formulation/API changes, in place of repeating a clinical food effect study.
By Jim Mullin & Ke Szeto