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
Food and Drug Administration
Description
This grant aims to develop tools to help create modified release (MR) oral drug products that are less likely to release drugs too quickly when exposed to alcohol, a problem known as alcohol dose dumping (ADD). Currently, different countries have different testing standards for ADD, which complicates product development for global markets. The research seeks to support regulatory decision-making, assist in designing MR drugs with low ADD potential, and provide evidence to help the FDA create…
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 re…
Source
Grant ID
FOR-FD-24-006
Funding Source
Food and Drug Administration
Eligibility
The following categories of applicants are invited to apply:
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- Private institutions of higher education
- Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"
- Independent school districts
- Small businesses
- County governments
- Public housing authorities/Indian housing authorities
- State governments
- Native American tribal governments (Federally recognized)
- For profit organizations other than small businesses
- City or township governments
- Native American tribal organizations (other than Federally recognized tribal governments)
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- Public and State controlled institutions of higher education
- Special district governments
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Awards & Funding
Award Ceiling
$250,000
Award Floor
$250,000
Funding Amount
Discretionary
Links
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