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

The Food and Drug Administration (FDA) is seeking research to identify drug-related and formulation-related factors that result in alcohol dose dumping of modified release oral drug products. The purpose of this research is to develop tools that facilitate the development of generic drug products with a low potential for alcohol dose dumping, support regulatory decision making, and provide evidence for the FDA to develop more specific recommendations. Some key points to consider: • 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 modified release oral drug products. • The research should focus on developing tools to facilitate the development of generic drug products with a low potential for alcohol dose dumping. • The award is for one year, and the budget is $250,000. • Eligible applicants include public and state-controlled institutions of higher education, nonprofits, small businesses, and others.