Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drug Products (U01) Clinical Trial Optional
This grant aims to improve prediction of food/drug interactions for high-risk oral drugs by using a lab model that mimics the gut to assess drug performance.
Funder: Food and Drug Administration
Due Dates: Forecasted (Estimated; not yet open)
Funding Amounts: Up to $500,000 per award; minimum $250,000; up to 2 awards; duration not specified.
Summary: Supports research to improve prediction of food-drug and drug-drug interaction risks for high-risk oral drugs using in vitro GI dissolution models.
Key Information: This is a forecasted opportunity; application details and deadlines are not yet available.
Description
This funding opportunity from the Food and Drug Administration (FDA) aims to advance the predictability of food-drug and drug-drug interaction risks for high-risk oral drug products. The focus is on developing and validating in vitro simulated gastrointestinal (GI) dissolution models to assess the performance of amorphous solid dispersion (ASD) drug products under clinically relevant conditions. The ultimate goal is to create mechanistic methodologies that correlate in vitro results with in vivo outcomes, thereby informing regulatory decisions, defining bioequivalence study requirements, and mitigating risks associated with therapeutic equivalence for generic oral drugs.
