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
Last verified by NonDilute: 2026-04-29. Official notice and agency instructions control.
If you research pharmaceutical formulations and drug delivery, the FDA will fund your investigation into why some oral meds dangerously dump their dose in alcohol.
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What this is
The FDA is seeking research to investigate why certain modified-release oral drug products rapidly release their entire dose when exposed to alcohol (dose dumping), which can cause serious safety problems. This U01 grant mechanism funds collaborative research but explicitly excludes clinical trials. Applicants should have expertise in pharmaceutical formulation science, pharmacokinetics, and/or drug product development to identify the chemical, physical, and formulation factors driving this phenomenon.
Who can apply
Eligibility criteria are unspecified in the provided text, but this is an FDA U01 grant (collaborative research) typically open to academic institutions, research organizations, small businesses, and non-profits. Clinical trial involvement is explicitly not allowed. Contact the FDA or review the full funding announcement (CFDA 93.103) for specific eligibility requirements.
Topics: alcohol dose dumping · modified release oral drugs · formulation science · pharmacokinetics · drug safety · pharmaceutical development
Public-source funding discovery only. This summary is generated from public agency data and may be incomplete or stale. NonDilute is not affiliated with, endorsed by, or acting on behalf of any government agency. Official notices and agency instructions control. NonDilute does not determine eligibility, provide grant-writing advice, or guarantee funding.