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

Posted May 25 Closed

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).

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 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.

View on Grants.gov

Agency Contact

Shashi Malhotra Grants Management Specialist

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.

Data sourced from the SAM.gov Assistance Listings and Grants.gov. See our methodology for details. Retrieved and formatted by PlainGrants