Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drug Products (U01) Clinical Trial Optional
ID: 351127Type: Forecasted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$250K - $500K

Eligible Applicants

Unrestricted

Funding Category

Consumer Protection

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/351127
Timeline
    Description

    The Food and Drug Administration (FDA) is offering a funding opportunity titled "Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drug Products (U01) Clinical Trial Optional." This initiative aims to explore the use of an in vitro simulated gastrointestinal dissolution model to assess the performance of amorphous solid dispersion (ASD) drug products under various clinically relevant conditions, ultimately enhancing the understanding of how food and acid-reducing agents affect drug absorption. The funding, which ranges from $250,000 to $500,000, is intended to support the development of methodologies that correlate in vitro observations with in vivo outcomes, thereby informing regulatory decisions for high-risk generic oral drug products. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or (240) 402-7610 for further information, with applications being accepted for the fiscal year 2024.

    Point(s) of Contact
    Terrin Brown Grantor
    (240) 402-7610
    terrin.brown@fda.hhs.gov
    Files
    No associated files provided.
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