Closed · FOR-FD-20-015 · CFDA 93.103 · Discretionary
PBPK Models of Oral Absorption to Simulate the Results of Bioequivalence Studies
Federal grant opportunity posted by Food and Drug Administration, cataloged on Grants.gov.
- Varies
- Award range
- Closed
- Status
- -
- Close date
- -
- Expected awards
The verdict
PBPK Models of Oral Absorption to Simulate the Results of Bioequivalence Studies is a closed discretionary listing from Food and Drug Administration that offered Varies by applicant. Future funding cycles may be published under the same CFDA number. PlainGrants indexes 481 other opportunities from Food and Drug Administration.
- Varies
- award range
- Closed
- application status
- 93.103
- CFDA program
- 481
- other opportunities from Food and Drug Administration
Archived opportunity record
PBPK Models of Oral Absorption to Simulate th… is closed. 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
This listing is no longer accepting applications
Instrument
Cooperative Agreement
Description
PBPK models are an effective tool to integrate the product characteristics and the physiology of the individual subject along with its variability within a population providing a means to simulate drug absorption and its subsequent disposition in the system without conducting in vivo pharmacokinetic studies. They have shown promise in supporting generic drug development and regulation. This opportunity solicits research proposals to expand the application of oral PBPK models to emerging issues in generic drug regulation that the Office of Generic Drugs (OGD) is currently facing. These issues include, but not limited to, 1) implementation of ICH guideline M9 (M9/M13)2) development of of ICH guideline M13 3) evaluation of alternative BE study designs motivated by public health emergencies such as to COVID-19The proposed research proposals are expected to include plans for the development and application of oral PBPK models that can simulate the results of bioequivalence studies and support OGD in addressing the above-mentioned issues. These simulations would include, but are not limited to, prediction of the results of fed BE studies, evaluation of excipient differences in the context of BCS III waiver requests, evaluation of dissolution differences in the context of BCS III waiver requests, identification of the most accurate, sensitive and reproducible analyte for BE determination, and evaluating modifications to BE study designs related to changes in the clinical trial environment due to public health emergencies.
Wide-open applicant board · 15 Grants.gov doors
PBPK Models of Oral Absorption to Simulate th… 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 7 other Food and Drug Administration listings share this exact eligibility-code string (1% of 482).
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- State governments
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- County governments
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- City or township governments
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- Special district governments
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- 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 21
- Individuals
- Code 22
- For-profit organizations other than small businesses
- Code 23
- Small businesses
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
Shashi Malhotra Grants Management Specialist
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What to do next
PBPK Models of Oral Absorption to Simulate th… 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 |