Physiologically Based Pharmacokinetic (PBPK) Models of Oral Absorption to Simulate the Results of Bioequivalence Studies (U01) Clinical Trials Optional

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Funding Opportunity ID:330745
Opportunity Number:RFA-FD-21-012
Opportunity Title:Physiologically Based Pharmacokinetic (PBPK) Models of Oral Absorption to Simulate the Results of Bioequivalence Studies (U01) Clinical Trials Optional
Opportunity Category:Discretionary
Opportunity Category Explanation:
Funding Instrument Type:Cooperative Agreement
Category of Funding Activity:Consumer Protection
Food and Nutrition
Science and Technology and other Research and Development
Category Explanation:
CFDA Number(s):93.103
Eligible Applicants: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)
Agency Code:HHS-FDA
Agency Name:Department of Health and Human Services
Food and Drug Administration
Posted Date:Jan 07, 2021
Close Date:Mar 15, 2021
Last Updated Date:Jan 07, 2021
Award Ceiling:$600,000
Award Floor:$300,000
Estimated Total Program Funding:
Expected Number of Awards:2
Description: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.
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