Award
Food and Drug Administration 5U01FD008304-02
Development of PBPK Model-Based Mechanistic IVIVCs for Long-Acting Injectable Suspensions
Recipient
University of Connecticut Storrs, Department of Pharmacology
Award Amount
$250,000.00
Ceiling
$250,000.00
Awarded
August 27, 2025
Identifier
5U01FD008304-02
The award supports research to develop PBPK model-based mechanistic in vitro-in vivo correlations (IVIVCs) for long-acting injectable suspensions to improve generic drug development and bioequivalence assessment, collaborating with the FDA.
Description
This project aims to develop a physiologically based pharmacokinetic (PBPK) model to predict in vivo drug release from long-acting injectable suspensions by understanding critical formulation attributes and process parameters. The goal is to facilitate bioequivalence recommendations for generic long-acting injectable suspensions, reduce regulatory burden, minimize clinical studies, and deliver cost-effective products safely and efficiently.