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Dermal Physiologically-based Pharmacokinetic (PBPK) Models Accounting for the Absorption and Evaporation of Vehicle/Co-solvent following the Application of Generic Dermatological Products (U01)
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.
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.
Agency: Department of Health and Human Services
Office: Food and Drug Administration
Estimated Funding: $600,000
Office: Food and Drug Administration
Estimated Funding: $600,000
Who's Eligible
Obtain Full Opportunity Text:
RFA-FD-21-019 - Full Announcement
Additional Information of 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)
Full Opportunity Web Address:
https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-21-019.html
Contact:
Agency Email Description:
shashi.malhotra@fda.hhs.gov
Agency Email:
Date Posted:
2021-02-17
Application Due Date:
Archive Date:
2021-05-22
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