Opportunity ID: 327615
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | FOR-FD-20-015 |
| Funding Opportunity Title: | PBPK Models of Oral Absorption to Simulate the Results of Bioequivalence Studies |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | May 25, 2021 |
| Last Updated Date: | May 25, 2021 |
| Original Closing Date for Applications: | – Archiving forecast |
| Current Closing Date for Applications: | – Archiving forecast |
| Archive Date: | May 26, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public housing authorities/Indian housing authorities City or township governments Private institutions of higher education Individuals Special district governments Public and State controlled institutions of higher education State governments For profit organizations other than small businesses Independent school districts Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Native American tribal organizations (other than Federally recognized tribal governments) |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| 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-19 The 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. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Shashi Malhotra
Grants Management Specialist Email:Shashi.malhotra@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Packages
Share This Post, Choose Your Platform!
About the Author: osnqt
