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

In plain English

Food and Drug Administration (Department of Health and Human Services) has announced this as a forecast: an opportunity it expects to post. It is not open for applications yet.

Individual awards range from $250,000 to $500,000 and the agency expects to make 2 awards.

Eligibility is listed as unrestricted (open to any type of applicant), subject to any clarification in the listing.

The listing says cost sharing or matching is not required.

Built only from the fields in the Grants.gov listing. Always confirm on the official listing.

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• Special district governments
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• Public and state-controlled institutions of higher education
• Native American tribal governments (federally recognized)
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• Native American tribal organizations (other than federally recognized tribal governments)
• Nonprofits with 501(c)(3) status (other than institutions of higher education)
• Nonprofits without 501(c)(3) status (other than institutions of higher education)
• Private institutions of higher education
• For-profit organizations other than small businesses
• Small businesses
• Others (see the eligibility details in the listing)
• Unrestricted (open to any type of entity above, subject to clarification in the listing)

Additional eligibility information (excerpt from the listing):

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 Submission of Resubmission Application. This means that the NIH or FDA will not accept:•A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.•A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the …

Excerpt from the official forecast on Grants.gov (shortened; read the full text on the official listing):

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, taking into consideration their potentially different formulations and manufacturing. …

Read the full forecast on Grants.gov →