Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional
Food and Drug Administration
Description
This research project aims to develop a physiologically based pharmacokinetic (PBPK) model to predict how two types of long-acting injectable drugs—crystalline suspensions and polymer-based implants—release their active ingredients in the body. The goal is to create a detailed model that considers both the drug’s formulation and biological factors to better understand and predict its behavior in the body. The model will use experimental data to validate these predictions and could potentiall…
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 …
Source
Grant ID
FOR-FD-24-002
Funding Source
Food and Drug Administration
Eligibility
The following categories of applicants are invited to apply:
- Public and State controlled institutions of higher education
- Native American tribal governments (Federally recognized)
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Public housing authorities/Indian housing authorities
- Independent school districts
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- State governments
- Private institutions of higher education
- Small businesses
- Special district governments
- City or township governments
- Native American tribal organizations (other than Federally recognized tribal governments)
- For profit organizations other than small businesses
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- County governments
Awards & Funding
Total Funding
$600,000
Award Ceiling
$300,000
Funding Amount
Discretionary
Links
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