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

The purpose of this funding opportunity is to examine the utility of an in vitro simulated gastrointestinal (GI) dissolution model for the assessment of in vitro performance of amorphous solid dispersion (ASD) drug products under different clinically relevant conditions. The goal is to develop and validate the in vitro mechanistic methodology to provide an improved understanding of impact of food and acid reducing agents on the absorption for test and reference listed drug (RLD) drug products. • The project aims to correlate in vitro observations to in vivo outcomes and inform regulatory decision-making. • The FDA will not accept duplicate or highly overlapping applications under review at the same time. • Applicant organizations may submit more than one application, provided that each application is scientifically distinct. • The award ceiling for this opportunity is $500,000, and the award floor is $250,000.