FOR-FD-24-005: FDA Grant on In Vitro GI Dissolution Model for Oral Drug Interaction Risks

The Food and Drug Administration (FDA) has announced a grant opportunity under the number FOR-FD-24-005, focusing on improving the predictability of food-drug and drug-drug interaction risks. This cooperative agreement aims to support the development and validation of an in vitro simulated gastrointestinal (GI) dissolution model for assessing the performance of amorphous solid dispersion (ASD) drug products under various clinically relevant conditions. The grant falls within the categories of agriculture, consumer protection, and food and nutrition, highlighting its importance in public health and safety.

Eligible applicants for this funding opportunity include a wide range of entities, from educational institutions and government bodies to non-profits and private sector organizations. The main objective of this research is to gain a better understanding of how food and acid-reducing agents affect the absorption of ASD drug products, considering their different formulations and manufacturing processes. The anticipated outcome is a bio predictive in vitro mechanistic methodology that can correlate in vitro findings with in vivo outcomes, aiding in the determination of the types of bioequivalence studies needed for ASD drug products. Additionally, this research will play a crucial role in informing regulatory decisions aimed at mitigating therapeutic equivalence risks for high-risk generic oral drug products. With an award ceiling of $500,000 and a floor of $250,000, this grant represents a significant step in enhancing the FDA’s capabilities in evaluating and ensuring the safety and efficacy of oral medications, particularly in the context of food and drug interactions.