The purpose of this funding opportunity is to develop a workflow for designing and performing a reliable virtual bioequivalence study by leveraging a physiologically-based pharmacokinetic (PBPK) model, validated for its intended purpose, to detect formulation differences between the reference standard
product and a prospective generic drug product.
The workflow will explore considerations and reasonable assumptions related to performing a virtual bioequivalence assessment using mechanistic modeling and simulation tools of increased complexity, such as PBPK models.