Physiologically-based pharmacokinetic (PBPK) models to aid the development of generic dermatological products (U01) Clinical Trials Optional

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Funding Opportunity ID:330299
Opportunity Number:RFA-FD-21-013
Opportunity Title:Physiologically-based pharmacokinetic (PBPK) models to aid the development of generic dermatological products (U01) Clinical Trials Optional
Opportunity Category:Discretionary
Opportunity Category Explanation:
Funding Instrument Type:Cooperative Agreement
Category of Funding Activity:Consumer Protection
Health
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
Additional Information on Eligibility: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:Dec 10, 2020
Close Date:Feb 15, 2021
Last Updated Date:Dec 10, 2020
Award Ceiling:$500,000
Award Floor:$250,000
Estimated Total Program Funding:
Expected Number of Awards:3
Description:The purpose of this project is to develop enhanced mechanistic physiologically-based pharmacokinetic (PBPK) models that allow the description of absorption through the skin of active ingredients applied as dermatological drug products. The developed models will be utilized to inform decisions on generic dermatological product development and to perform virtual bioequivalence assessments in support of regulatory decisions.
Version:1





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