Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional
This FDA funding opportunity seeks development of physiologically-based pharmacokinetic (PBPK) modeling and mechanistic in vitro-in vivo correlation (IVIVC) approaches for long-acting injectable suspensions and implants. The research aims to improve drug development efficiency and regulatory decision-making for complex formulations.