U01 research to predict and prevent alcohol dose dumping in modified-release oral drugs
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-maki…
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…
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Awards & funding
Eligibility
Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The FDA will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application. This means that the NIH…
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