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
ID: 351808Type: Posted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$0 - $250K

Eligible Applicants

Unrestricted

Funding Category

Food and Nutrition

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes
Timeline
  1. 1
    Forecast Posted Not available
  2. 2
    Forecast Due Not available
  3. 3
    Posted Jan 15, 2024 12:00 AM
  4. 4
    Due Apr 8, 2024 12:00 AM
Description

The Food and Drug Administration (FDA) is offering a federal grant opportunity titled "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". This grant aims to address the risk of alcohol dose dumping (ADD) in modified release (MR) oral drug products. MR oral drug products are designed to release drugs over an extended period of time and can pose a high risk if exposed to alcohol, leading to severe side effects and even death.

To mitigate this risk, the FDA recommends conducting in vitro alcohol dose dumping assessments in different alcoholic dissolution media for prospective generic versions of MR oral drug products. However, there is currently a lack of global harmonization in ADD assessments, with different recommendations from regulatory agencies. This discrepancy presents challenges for formulators designing products for multiple markets, as the release from MR oral products may not always follow a linear response to increasing alcohol concentrations.

The purpose of this grant is to develop tools that facilitate the development of MR generic drug products with a low potential for ADD, support regulatory decision making during the assessment of such products, and provide evidence for the FDA to develop more specific recommendations. The research aims to improve the understanding of drug-related and formulation-related factors that contribute to ADD and enable the development of safer MR oral drug products.

For more information about this grant opportunity, please visit the following link: RFA-FD-24-010 Funding Opportunity Announcement

Point(s) of Contact
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