Director, Pharmacokinetics, Modeling and Simulation Astellas Pharma, Illinois
This presentation will cover a particular case study on the use of PBPK/PBBM modeling to conduct virtual bioequivalence simulations to assess the impact of different in vitro release characteristics between two drug products. A case illustrating the application of PBPK modeling for the purpose of setting clinically meaningful dissolution specifications will also be presented. This presentation will include a detailed description of mechanisms of dissolution, absorption, distribution, and elimination of a drug in the human body with a discussion of how specific properties of the active pharmaceutical ingredient affects in vivo absorption.
Upon completion, participants will be able to gain an overview of the factors that need to be considered when undertaking a PBPK modeling plan for a certain drug substance or a certain formulation.
Upon completion, participants will be able to know how to integrate in vitro/in vivo data into a PBPK model development/validation workflow and perform virtual BE simulations.
Upon completion, participants will be gain an appreciation of assumptions and uncertainties in any model-based approaches and how to assess their risk in using the model for regulatory purposes.