Designing and performing a virtual bioequivalence trial for physiologically-based pharmacokinetic and other mechanism-based models
Department of Health and Human Services Food and Drug Administration
Typ
Fellowships
Posted on:
Reference Number
RFA-FD-23-016
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.
Categories: Consumer Protection, Science and Technology and other Research and Development.
Categories: Consumer Protection, Science and Technology and other Research and Development.