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Open Federal Grants · Food and Drug Administration

Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional

Food and Drug Administration · Opportunity FOR-FD-24-002 · Awards up to $300,000

Opportunity NumberFOR-FD-24-002
Award FloorNot stated in the listing
Award Ceiling$300,000
Cost Sharing / MatchingNot required by the listing
Application DeadlineNo fixed deadline — see the official listing
Last Updated on Grants.govNov 21, 2023
Who Can ApplyState governments, County governments, City / township governments, Regional organizations, U.S. territories & freely associated states, Independent school districts, Federally recognized tribal governments, Public housing authorities, Native American tribal organizations, Nonprofits with 501(c)(3) status, Nonprofits without 501(c)(3) status, Private colleges / universities, For-profit organizations, Small businesses, Other applicants

Eligibility

Independent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional OrganizationsNon-

Eligibility text quoted from the official Grants.gov listing.

About This Opportunity

The objective of this research proposal is to develop physiologically based pharmacokinetic (PBPK) model-based mechanistic in vitro in vivo correlations (IVIVCs) for two major types of long acting injectables (LAIs) such as crystalline suspensions and polymer-based implants by considering their distinct characteristics. The goal of the project is to develop a bottom-up mechanistic PBPK model for these two LAI categories by accounting for the influence of critical formulation attributes of each L …

Description from the official Grants.gov listing — read the complete notice, including any updates, on Grants.gov before applying.

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