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Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional
Due: Apr 8, 2024
HHS-FDA
$300,000
Description
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 LAI drug product type to predict its...
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Estimated Total Program Funding
$300,000
Expected Number of Awards
2
Award Ceiling
$300,000
Eligible Applicants
- State governments
- County governments
- City or township governments
- Special district governments
- Independent school districts
- Public and State controlled institutions of higher education
- Native American tribal governments (Federally recognized)
- Public housing authorities/Indian housing authorities
- Native American tribal organizations (other than Federally recognized tribal governments)
- Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education
- Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education
- Private institutions of higher education
- For-profit organizations other than small businesses
- Small businesses
- Unrestricted
Funding Type
Cooperative Agreement
Categories of Funding Activity
- Agriculture
- Consumer Protection
- Food and Nutrition
Opportunity Type
Discretionary
Grantor Contact Information
terrin.brown@fda.hhs.gov
Other Grantor Informaiton
Terrin Brown Grantor
Additional information
RFA-FD-24-006 Funding Opportunity Announcement
Supporting Link
https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-24-006.html
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