The purpose of this project is to develop and implement a virtual bioequivalence trial simulation platform that can be used to perform population-based statistical analysis in complex and computationally intensive physiologically based pharmacokinetic (PBPK) models developed to describe the absorption,
distribution and elimination of active pharmaceutical ingredients formulated in complex and non-complex dosage forms administered via oral or non-oral routes.
The developed virtual bioequivalence trial simulation platform will be used to generate predictions on the in vivo drug product performance, to perform bioequivalence assessments between brand name and generic drug products and to inform regulatory decisions relating to generic drug development.