Opportunity
Simpler Grants.gov #FOR-FD-24-002
FDA Solicits Research for PBPK Model-Based IVIVCs for Long Acting Injectables
Buyer
Food and Drug Administration
Posted
November 21, 2023
Identifier
FOR-FD-24-002
NAICS
541715
The Food and Drug Administration (FDA) is seeking research partners to develop advanced PBPK model-based mechanistic IVIVCs for long acting injectable drug products. - Government Buyer: - Food and Drug Administration (FDA) - Products/Services Requested: - Research and development services to create physiologically based pharmacokinetic (PBPK) model-based mechanistic in vitro in vivo correlations (IVIVCs) - Focus on two types of long acting injectables: - Crystalline suspensions - Polymer-based implants - Model development must: - Account for critical formulation attributes - Predict in vivo release mechanisms - Be informed by in vitro and in vivo experiments - Be validated using a preclinical animal model - Models should help define safe formulation spaces, explain pharmacokinetic variability, and enable human extrapolation - Unique/Notable Requirements: - No specific OEMs or vendors are named; this is a research grant opportunity - Up to two awards expected - No cost sharing or matching required - Funding instrument is a cooperative agreement - Estimated funding up to $600,000 (minimum $300,000) - Place of Performance: - Food and Drug Administration (FDA)
Description
This research proposal aims to develop physiologically based pharmacokinetic (PBPK) model-based mechanistic in vitro in vivo correlations (IVIVCs) for two major types of long acting injectables: crystalline suspensions and polymer-based implants. The project focuses on creating a bottom-up mechanistic PBPK model that accounts for critical formulation attributes to predict in vivo release mechanisms. The model will be informed by suitable in vitro and in vivo experiments and validated using a preclinical animal model. The developed model will help understand the influence of drug and formulation properties on in vivo release and disposition, define safe formulation spaces, explain pharmacokinetic variability, and extrapolate predictions to humans.