GrantRound

Open Federal Grants · Food and Drug Administration

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

Food and Drug Administration · Opportunity FOR-FD-24-005 · Awards $250,000–$500,000

Opportunity NumberFOR-FD-24-005
Award Floor$250,000
Award Ceiling$500,000
Cost Sharing / MatchingNot required by the listing
Application DeadlineNo fixed deadline — see the official listing
Last Updated on Grants.govNov 30, 2023
Who Can ApplyAll applicant types

Eligibility

Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The FDA will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submissi

Eligibility text quoted from the official Grants.gov listing.

About This Opportunity

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, t …

Description from the official Grants.gov listing — read the complete notice, including any updates, on Grants.gov before applying.

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