Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional
Agency: Food and Drug Administration
Assistance Listings: 93.103 -- Food and Drug Administration Research
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 in vivo release mechanism. The model formulation parameters and relevant physiology should be informed with suitable in vitro and in vivo experiments. A suitable preclinical animal model can be used to validate the PBPK model based IVIVCs for both LAI suspensions and polymer based implants.
...The use of PBPK modelling provides a unique opportunity to understand how the physicochemical properties of drug molecules/polymer, implant specific properties, critical formulation attributes, and physiology, among other things, influence the in vivo release mechanisms of LAI drug products and their disposition characteristics. Moreover, once developed, a mechanistic PBPK model can help to define the 'safe space' for critical formulation attributes relevant to the reference listed drug (RLD) product, explain sources of PK variability and extrapolate predictions to human subjects by leveraging animal model data and by accounting for species-specific physiological differences.
Eligibility
Eligible applicants
Nonprofit
- Nonprofits non-higher education with 501(c)(3)
- Nonprofits non-higher education without 501(c)(3)
- Other Native American tribal organizations
Education
- Independent school districts
- Public and state institutions of higher education
- Private institutions of higher education
Government
- County governments
- Federally recognized Native American tribal governments
- Public and Indian housing authorities
- State governments
- Special district governments
- City or township governments
Miscellaneous
- Other
Business
- For-profit organizations other than small businesses
- Small businesses
Additional information
Grantor contact information
Description
Terrin.Brown@fda.hhs.gov
Documents
No documents are currently available.
Link to additional information
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Forecasted
Estimated Post Date:
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Estimated Application Due Date:
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Estimated Due Date Description:
Not available
Estimated Award Date:
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Estimated Project Start Date:
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Fiscal Year:
2024
Award
$600,000
Program Funding
2
Expected awards
$--
Award Minimum
$300,000
Award Maximum
Funding opportunity number:
FOR-FD-24-002
Cost sharing or matching requirement:
Funding instrument type:
Cooperative agreement
Opportunity Category:
Discretionary
Opportunity Category Explanation:
Category of Funding Activity:
Health
Food and nutrition
Science technology and other research and development
Category Explanation:
History
Version:
1
Forecast posted date:
November 21, 2023
Archive date:
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