Identification of Drug-related and Formulation-Related Factors that Result in Alcohol Dose Dumping of Modified Release Oral Drug Products (U01) Clinical Trial Not Allowed
Identification of Drug-related and Formulation-Related Factors that Result in Alcohol Dose Dumping of Modified Release Oral Drug Products (U01) Clinical Trial Not Allowed is offered by Food and Drug Administration. Max award: $250,000. This is a forecast; the deadline is not set yet.
| Opportunity number | FOR-FD-24-006 |
|---|---|
| Agency | Food and Drug Administration |
| Status | Forecasted |
| Posted | Nov 24, 2023 |
| Closes | Not set |
| Award ceiling | $250,000 |
| Award floor | $250,000 |
| Total program funding | Not specified |
| Expected awards | 1 |
| Who can apply | Native American tribal governments (Federally recognized), Private institutions of higher education, State governments, Public and State controlled institutions of higher education, For profit organizations other than small businesses, Others (see text field entitled "Additional Information on Eligibility" for clarification), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, 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", Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Special district governments, Independent school districts, Small businesses, County governments, Public housing authorities/Indian housing authorities |
| Category | Agriculture, Consumer Protection, Food and Nutrition |
Summary (excerpt)
Modified release (MR) oral drug products are considered to have a high risk for alcohol dose dumping (ADD) because they contain large quantities of drug(s), designed to release over a prolonged period of time. Accidental exposure of these products to alcohol can result in the relatively rapid release of large quantities of drug with severe side effects, including death. To mitigate this risk, the FDA recommends conducting an in vitro alcohol dose…
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