Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional
ID: 351078Type: Forecasted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$0 - $300K

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/351078
Timeline
    Description

    The Food and Drug Administration (FDA) is forecasting a federal grant opportunity titled "Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional." This initiative aims to develop physiologically based pharmacokinetic (PBPK) models to establish mechanistic in vitro in vivo correlations (IVIVCs) for long-acting injectables, specifically crystalline suspensions and polymer-based implants, by analyzing their unique characteristics and formulation attributes. The project is significant for enhancing the understanding of drug release mechanisms and disposition characteristics, which can ultimately inform safer and more effective drug formulations. The estimated total program funding is $600,000, with an award ceiling of $300,000 and an expected two awards. Interested applicants can contact Terrin Brown, Grants Management Specialist, at Terrin.Brown@fda.hhs.gov or by phone at 240-402-7610 for further details.

    Point(s) of Contact
    Terrin Brown Grants Management Specialist
    (240) 402-7610
    Terrin.Brown@fda.hhs.gov
    Files
    No associated files provided.
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