The Food and Drug Administration (FDA) is offering a federal grant opportunity titled "Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional". This grant aims to develop physiologically based pharmacokinetic (PBPK) model-based mechanistic in vitro in vivo correlations (IVIVCs) for long-acting injectables (LAIs) such as crystalline suspensions and polymer-based implants.
The objective of this research proposal is to create a bottom-up mechanistic PBPK model for these two categories of LAIs by considering their distinct characteristics and the influence of critical formulation attributes. The goal is to predict the in vivo release mechanism of each LAI drug product type by incorporating relevant physiology and suitable in vitro and in vivo experiments. The PBPK model can be validated using a suitable preclinical animal model.
This research will provide insights into how the physicochemical properties of drug molecules/polymer, implant-specific properties, critical formulation attributes, and physiology influence the in vivo release mechanisms and disposition characteristics of LAI drug products. The developed PBPK model will help define the "safe space" for critical formulation attributes, explain sources of pharmacokinetic variability, and extrapolate predictions to human subjects by leveraging animal model data and accounting for species-specific physiological differences.
The grant has an estimated total program funding of $600,000, with an award ceiling of $300,000. It is a cooperative agreement and falls under the category of funding activity related to health. The grant is forecasted for the fiscal year 2024, and it is open to eligible applicants, including independent school districts, public housing authorities, Native American tribal organizations, and non-domestic entities.
For more information, interested parties can contact Terrin Brown, a Grants Management Specialist at the FDA, via email at Terrin.Brown@fda.hhs.gov or by phone at 240-402-7610.