Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional
This grant aims to create PBPK models for long-acting injectable suspensions and implants, predicting drug release by linking formulation attributes to in-vivo performance.
Funder: Food and Drug Administration
Due Dates: Forecasted (no due date posted)
Funding Amounts: Up to $300,000 per award; total program funding $600,000; project period and number of awards not yet finalized.
Summary: Supports development of PBPK model-based mechanistic IVIVCs for long-acting injectable suspensions and implants, linking formulation attributes to in vivo drug release.
Key Information: This is a forecasted opportunity; application details and deadlines are not yet available.
Description
This forecasted FDA opportunity will fund research to develop physiologically based pharmacokinetic (PBPK) model-based mechanistic in vitro–in vivo correlations (IVIVCs) for two major types of long-acting injectables (LAIs): crystalline suspensions and polymer-based implants. The aim is to create bottom-up mechanistic PBPK models that account for the unique formulation attributes and physiological factors influencing in vivo drug release and disposition for these LAI products.
The project should:
- Develop PBPK models for both LAI suspensions and polymer-based implants.
- Use in vitro and in vivo experiments to inform model parameters and relevant physiology.
- Validate the models using suitable preclinical animal models.
- Enable prediction of in vivo release mechanisms, define the “safe space” for critical formulation attributes, explain sources of pharmacokinetic variability, and extrapolate findings to humans by leveraging animal data and accounting for species-specific differences.
PBPK modeling is expected to advance understanding of how drug and polymer properties, formulation characteristics, and physiological factors impact the performance of LAI drug products.
