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
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 is offered by Food and Drug Administration. Max award: $500,000. This is a forecast; the deadline is not set yet.
| Opportunity number | FOR-FD-24-005 |
|---|---|
| Agency | Food and Drug Administration |
| Status | Forecasted |
| Posted | Nov 24, 2023 |
| Closes | Not set |
| Award ceiling | $500,000 |
| Award floor | $250,000 |
| Total program funding | Not specified |
| Expected awards | 2 |
| Who can apply | Public and State controlled institutions of higher education, Special district governments, County governments, For profit organizations other than small businesses, Public housing authorities/Indian housing authorities, City or township governments, Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility", Private institutions of higher education, Others (see text field entitled "Additional Information on Eligibility" for clarification), State governments, Small businesses, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Native American tribal governments (Federally recognized), Independent school districts, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| Category | Agriculture, Consumer Protection, Food and Nutrition |
Summary (excerpt)
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 tes…
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