Physiologically Based Pharmacokinetic (PBPK) Models of Oral Absorption to Simulate the Results of Bioequivalence Studies (U01) Clinical Trials Optional
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Physiologically Based Pharmacokinetic (PBPK) Models of Oral Absorption to Simulate the Results of Bioequivalence Studies (U01) Clinical Trials Optional: Physiologically based pharmacokinetic (PBPK) models are an effective tool to integrate information about the product characteristics, the physiology of the individual subject, and the variability among subjects within a population to simulate the absorption and subsequent systemic disposition of the drug without conducting in vivo pharmacokinetic studies. These PBPK models have shown promise in supporting generic drug development and regulatory decision making. This opportunity solicits research proposals to expand the application of oral PBPK models to emerging issues in generic drug fields by providing the ability to simulate bioequivalence studies under various conditions.
Federal Grant Title: | Physiologically Based Pharmacokinetic (PBPK) Models of Oral Absorption to Simulate the Results of Bioequivalence Studies (U01) Clinical Trials Optional |
Federal Agency Name: | Food and Drug Administration (HHS-FDA) |
Grant Categories: | Consumer Protection Food and Nutrition Science and Technology |
Type of Opportunity: | Discretionary |
Funding Opportunity Number: | RFA-FD-21-012 |
Type of Funding: | Cooperative Agreement |
CFDA Numbers: | 93.103 |
CFDA Descriptions: | Information not provided |
Current Application Deadline: | March 15th, 2021 |
Original Application Deadline: | March 15th, 2021 |
Posted Date: | January 7th, 2021 |
Creation Date: | January 7th, 2021 |
Archive Date: | April 14th, 2021 |
Total Program Funding: | |
Maximum Federal Grant Award: | $600,000 |
Minimum Federal Grant Award: | $300,000 |
Expected Number of Awards: | 2 |
Cost Sharing or Matching: | No |
Last Updated: | January 7th, 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 - For-profit organizations other than small businesses - Small businesses - Others (see text field entitled "Additional Information on Eligibility" for clarification.)
- Additional Information on Eligibility
- Eligible Organizations Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations Small Businesses For-Profit Organizations (Other than Small Businesses) Governments State Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U.S. Territory or Possession Other Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions)
- Link to Full Grant Announcement
- Full Announcement
- Grant Announcement Contact
- Shashi Malhotra
Grants Management Specialist
Phone 2404027592
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