Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional
View forecast on Grants.gov →Forecasted — not yet open · no update since it was posted
- Posted
- November 21, 2023
- Closes
- See announcement
- Award ceiling
- $300,000
- Program funding
- $600,000
- Expected awards
- 2
- Cost sharing
- No
- Instrument
- Cooperative Agreement
- Assistance listing
- 93.103
Program funding history
Awards made under Assistance Listing 93.103 across FY2025–FY2027, from public federal spending records.
- FY2025 obligated
- $213M
- FY2026 obligated
- $215.3M
- FY2027 (to date) obligated
- $0
- Awards in window
- 849
Top recipients: The Critical Path Institute, National Environmental Health Association, Association of Food & Drug Officials, Yale Univ, Food & Agriculture, California Department of
Source: USAspending.gov · refreshed October 2026 · Program page: awards, recipients and the opportunities under this listing →
Synopsis
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.
Who can apply
- County governments
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- Native American tribal governments (Federally recognized)
- Native American tribal organizations (other than Federally recognized tribal governments)
- Special district governments
- Small businesses
- Public housing authorities/Indian housing authorities
- 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
- For profit organizations other than small businesses
- City or township governments
- Private institutions of higher education
- Independent school districts
- Public and State controlled institutions of higher education
- State governments
Independent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional OrganizationsNon-domestic (non-U.S.) Entities (Foreign Institutions
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