Closed · RFA-FD-24-006 · CFDA 93.103 · Discretionary
Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional
Federal grant opportunity posted by Food and Drug Administration, cataloged on Grants.gov.
- up to $300K
- Award range
- Closed
- Status
- April 8, 2024
- Close date
- 2
- Expected awards
The verdict
Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional is a closed discretionary listing from Food and Drug Administration that offered Up to $300,000 across 2 expected awards. Future funding cycles may be published under the same CFDA number. PlainGrants indexes 481 other opportunities from Food and Drug Administration.
- up to $300K
- award range
- Closed
- application status
- 2
- expected awards
- 93.103
- CFDA program
Archived opportunity record
Developing PBPK Model-Based Mechanistic IVIVC… is closed (last close April 8, 2024). The parent program page for CFDA 93.103 is the reliable place to catch re-announcements. Food and Drug Administration still indexes 481 other opportunities here.
According to Grants.gov (extract vintage 2026-08-10), this record reflects the officially published listing. See methodology.
Deadline tracker
Application window closed
Closed April 8, 2024
Est. Total Funding
$300,000
Expected Awards
2
Instrument
Cooperative Agreement
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.
Wide-open applicant board · 15 Grants.gov doors
Developing PBPK Model-Based Mechanistic IVIVC… prints 15 distinct Grants.gov eligibility doors (State governments; County governments; City or township governments; Special district governments; +11 more). Filter fit before reading award size as demand — most applicant classes appear on the row. The extract does not mark applicant cost-sharing as required. Instrument: Cooperative Agreement. Funding-activity codes span Agriculture · Consumer Protection · Food and Nutrition (AG;CP;FN). Only 11 other Food and Drug Administration listings share this exact eligibility-code string (2% of 482).
- Code 00
- State governments
- Code 01
- County governments
- Code 02
- City or township governments
- Code 04
- Special district governments
- Code 05
- Independent school districts
- Code 06
- Public / state-controlled institutions of higher education
- Code 07
- Federally recognized tribal governments
- Code 08
- Public / Indian housing authorities
- Code 11
- Native American tribal organizations (other than Federally recognized tribal governments)
- Code 12
- Nonprofits with 501(c)(3) status (other than IHEs)
- Code 13
- Nonprofits without 501(c)(3) status (other than IHEs)
- Code 20
- Private institutions of higher education
- Code 22
- For-profit organizations other than small businesses
- Code 23
- Small businesses
- Code 99
- Unrestricted / see official listing
Codes are Grants.gov eligibility category values from the extract vintage 2026-08-10. Confirm the full eligibility statement on the official listing or the Grants.gov eligibility reference.
Official Listing on Grants.gov
View full details, application forms, and submission instructions.
Parent Grant Program
Food and Drug Administration Research
U.S. Department of Health and Human Services
Agency Contact
Terrin Brown Grantor
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What to do next
Developing PBPK Model-Based Mechanistic IVIVC… is closed; use the parent program and agency catalog for the next funding cycle.
- Parent CFDA 93.103 may publish future NOFOs under the same assistance listing. Open program
- Food and Drug Administration Research indexes 42 Grants.gov listings in this extract. Program profile
- Food and Drug Administration lists 481 other indexed opportunities on PlainGrants. Agency catalog
Opportunity deadlines and eligibility change on Grants.gov; PlainGrants mirrors the extract and is not the submission system.
Disclaimer: This information is sourced from Grants.gov and SAM.gov and is for informational purposes only. Opportunity details, deadlines, and eligibility requirements change frequently. Always verify current information directly on Grants.gov before applying. PlainGrants is not affiliated with any federal agency.
Read our methodology - how this data is sourced, computed, and verified.
| Publisher | PlainGrants |
| Sources | the SAM.gov Assistance Listings and Grants.gov |