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.
- Varies
- award range
- Closed
- application status
- 93.103
- CFDA program
Opportunity snapshot. This Grants.gov announcement - PBPK Models of Oral Absorption to Simulate the Results of Bioequivalence Studies - is cataloged under number FOR-FD-20-015 and tied to CFDA assistance listing 93.103, posted by Food and Drug Administration. Grants.gov currently shows the opportunity as closed, first posted on May 25, 2021. The funding category is Discretionary, delivered as a cooperative agreement.
Award economics. The award range on file is Varies by applicant. Cost sharing is not required, so applicants do not need to commit matching funds to be competitive on this opportunity. Federal award ranges are often upper bounds; actual allocations reflect program appropriations, the strength of the applicant pool, and the evaluation committee's scoring.
Deadline and action path. This opportunity is closed. Monitoring the parent program page is the most reliable way to catch re-announcements in the next funding cycle. Every Grants.gov submission requires an active SAM.gov registration and a Unique Entity ID. Review the Eligibility section below carefully, federal eligibility categories (nonprofit, state or local government, tribal, individual, educational institution, small business) have distinct registration and reporting requirements. Pre-application outreach to the listed agency contact is permitted and often welcomed, it helps clarify scope and scoring priorities. Before acting on the deadline or award figures above, verify them directly on the official Grants.gov listing, amendments can change dates and amounts after this page was last refreshed.
Award Range
Varies by applicant
Close Date
Not specified
Archiving forecast
Posted
May 25, 2021
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.
Eligibility
Grants.gov lists this opportunity under eligibility category codes 00, 01, 02, 04, 05, 06, 07, 08, 11, 12, 13, 20, 21, 22, 23. These codes correspond to applicant types (state/local government, tribal organization, nonprofit, educational institution, individual, small business, etc.) defined in Grants.gov's own eligibility reference. See the current Grants.gov eligibility categories or check the official listing below for this opportunity's exact eligibility statement.
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
Key Dates
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