Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional
Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional is offered by Food and Drug Administration. Max award: $300,000. This is a forecast; the deadline is not set yet.
| Opportunity number | FOR-FD-24-002 |
|---|---|
| Agency | Food and Drug Administration |
| Status | Forecasted |
| Posted | Nov 21, 2023 |
| Closes | Not set |
| Award ceiling | $300,000 |
| Award floor | Not specified |
| Total program funding | $600,000 |
| Expected awards | 2 |
| Who can apply | Native American tribal organizations (other than Federally recognized tribal governments), Independent school districts, Others (see text field entitled "Additional Information on Eligibility" for clarification), Native American tribal governments (Federally recognized), County governments, Small businesses, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Public and State controlled institutions of higher education, City or township governments, Special district governments, Public housing authorities/Indian housing authorities, Private institutions of higher education, State governments, For profit organizations other than small businesses |
| Category | Food and Nutrition, Health, Science and Technology and other Research and Development |
Summary (excerpt)
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 infl…
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