Dermal Physiologically-based Pharmacokinetic (PBPK) Models Accounting for the Absorption and Evaporation of Vehicle/Co-solvent following the Application of Generic Dermatological Products (U01)

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Funding Opportunity ID:331582
Opportunity Number:RFA-FD-21-019
Opportunity Title:Dermal Physiologically-based Pharmacokinetic (PBPK) Models Accounting for the Absorption and Evaporation of Vehicle/Co-solvent following the Application of Generic Dermatological Products (U01)
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: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: o Hispanic-serving Institutions o Historically Black Colleges and Universities (HBCUs) o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutions o 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:Feb 17, 2021
Close Date:Apr 22, 2021
Last Updated Date:Feb 17, 2021
Award Ceiling:$500,000
Award Floor:$250,000
Estimated Total Program Funding:
Expected Number of Awards:2
Description:The overall objective of this funding opportunity is to develop an enhanced mechanistic PBPK model for generic dermatological drug products by taking account the absorption and evaporation of vehicle/co-solvent simultaneously and implementing the effect of these two dynamic processes on the permeation of drug molecule through skin. The developed model will be utilized to inform decisions on generic dermatological product development, to enhance the understanding of the effect of metamorphosis of dermatological drug products on skin absorption, and to predict the local and systemic exposure of drug molecule following topical application of dermatological drug products.
Version:1





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