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
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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: 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 dumping assessment in 0%, 5%, 20%, and 40% alcoholic dissolution media for all prospective generic versions of MR oral drug products. To date, ADD assessments have not been harmonized globally. For instance, the U.S. FDA recommends testing up to 40% alcoholic media while the European Medicines Agency recommends testing up to 20% alcoholic media. This type of difference can present a challenge for formulators designing products for multiple markets, as historical data has shown release from MR oral products do not always follow a linear response (either increasing or decreasing) to increasing alcohol concentrations. In addition, interpretation of an ADD assessment may be limited by the inability of the test to predict in vivo behavior. The purpose of this research is to develop tools that 1) facilitate the development of MR generic drug products that have a low potential for ADD, 2) support regulatory decision making during the assessment of such products, and 3) provide evidence that enables FDA to develop more specific recommendations for efficiently demonstrating a low or comparative potential of alcohol dose dumping for MR oral drug products containing high risk drugs.
Federal Grant Title: | 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 |
Federal Agency Name: | Food and Drug Administration (HHS-FDA) |
Grant Categories: | Agriculture Consumer Protection Food and Nutrition |
Type of Opportunity: | Discretionary |
Funding Opportunity Number: | RFA-FD-24-010 |
Type of Funding: | Cooperative Agreement |
CFDA Numbers: | 93.103 |
CFDA Descriptions: | Information not provided |
Current Application Deadline: | March 31st, 2024 |
Original Application Deadline: | March 31st, 2024 |
Posted Date: | January 15th, 2024 |
Creation Date: | January 15th, 2024 |
Archive Date: | April 30th, 2024 |
Total Program Funding: | $250,000 |
Maximum Federal Grant Award: | $250,000 |
Minimum Federal Grant Award: | |
Expected Number of Awards: | 1 |
Cost Sharing or Matching: | No |
Last Updated: | January 15th, 2024 |
- Applicants Eligible for this Grant
- State governments - County governments - City or township governments - Special district governments - Independent school districts - Public and State controlled institutions of higher education - Native American tribal governments (Federally recognized) - Public housing authorities/Indian housing authorities - 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 - Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education - Private institutions of higher education - For-profit organizations other than small businesses - Small businesses - Unrestricted (i.e., open to any type of entity below), subject to any clarification in text field entitled "Additional Information on Eligibility"
- Grant Announcement Contact
- Terrin Brown
Grantor
Phone 2404027610
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