Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional
ID: 351804Type: Posted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$0 - $300K

Eligible Applicants

Unrestricted

Funding Category

Food and Nutrition

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/351804

Additional Information

https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-24-006.html
Timeline
    Description

    The U.S. Food and Drug Administration (FDA) has announced a funding opportunity aimed at developing physiologically based pharmacokinetic (PBPK) model-based mechanistic in vitro-in vivo correlations (IVIVCs) for long-acting injectables (LAIs), specifically crystalline suspensions and polymer-based implants. The objective is to create a PBPK model that incorporates critical formulation attributes to better predict in vivo drug release mechanisms, thereby enhancing the understanding of pharmacokinetics and variability in transitioning from animal models to human predictions. This initiative is crucial for addressing gaps in the pharmacokinetic profiles of LAIs and supporting the development of generic products. Interested applicants, including higher education institutions and nonprofits, can apply for up to $600,000 in funding for two awards, with applications due by April 8, 2024. For further details, contact Terrin Brown at terrin.brown@fda.hhs.gov or visit the funding announcement at https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-24-006.html.

    Point(s) of Contact
    terrin.brown@fda.hhs.gov
    Files
    Title
    Posted
    RFA-FD-24-006.html
    The Department of Health and Human Services, through the U.S. Food and Drug Administration (FDA), has issued a Notice of Funding Opportunity (NOFO) focused on developing mechanistic in vitro-in vivo correlations (IVIVCs) for long-acting injectables (LAIs) like crystalline suspensions and polymer-based implants. The goal is to create a physiologically based pharmacokinetic (PBPK) model that accounts for critical formulation attributes and their effects on in vivo drug release mechanisms. This initiative seeks to enhance understanding of how formulation characteristics influence pharmacokinetics and variability when transitioning from animal models to human predictions. Key dates include the NOFO posting on November 13, 2023, with application deadlines set for March 31, 2024. Eligible applicants include higher education institutions, nonprofits, and various levels of government. Up to $600,000 is allocated for funding two awards over a three-year project period. Each year’s funding is capped, and successful applicants are expected to collaborate closely with FDA staff. The ultimate aim of the research is to generate validated PBPK models to support the creation of generic LAI products, addressing current gaps in the understanding of their complicated pharmacokinetic profiles.
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