PBPK Models of Oral Absorption to Simulate the Results of Bioequivalence Studies
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PBPK Models of Oral Absorption to Simulate the Results of Bioequivalence Studies: 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.
Federal Grant Title: | PBPK Models of Oral Absorption to Simulate the Results of Bioequivalence Studies |
Federal Agency Name: | Food and Drug Administration (HHS-FDA) |
Grant Categories: | Agriculture Consumer Protection Food and Nutrition |
Type of Opportunity: | Discretionary |
Funding Opportunity Number: | FOR-FD-20-015 |
Type of Funding: | Cooperative Agreement |
CFDA Numbers: | 93.103 |
CFDA Descriptions: | Information not provided |
Current Application Deadline: | May 11th, 2021 |
Original Application Deadline: | May 11th, 2021 |
Posted Date: | May 25th, 2021 |
Creation Date: | May 25th, 2021 |
Archive Date: | May 26th, 2021 |
Total Program Funding: | |
Maximum Federal Grant Award: | |
Minimum Federal Grant Award: | |
Expected Number of Awards: | |
Cost Sharing or Matching: | No |
Last Updated: | May 25th, 2021 |
- Applicants Eligible for this Grant
- State governments - County governments - City or township governments - Special district governments - Independent school districts - Public and State controlled institutions of higher education - Native American tribal governments (Federally recognized) - Public housing authorities/Indian housing authorities - Native American tribal organizations (other than Federally recognized tribal governments) - Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education - Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education - Private institutions of higher education - Individuals - For-profit organizations other than small businesses - Small businesses
- Grant Announcement Contact
- Shashi Malhotra
Grants Management Specialist
[email protected] - Similar Government Grants
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