Physiologically-based pharmacokinetic (PBPK) models to aid the development of generic dermatological products (U01) Clinical Trials Optional
ArchivedFood and Drug Administration
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.
Who can apply
- 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)
- Nonprofits with 501(c)(3) status (other than higher education)
- Nonprofits without 501(c)(3) status (other than higher education)
- Private institutions of higher education
- For-profit organizations other than small businesses
- Small businesses
Contact
Shashi Malhotra <br/>Grants Management Specialist <br/>Phone 2404027592
shashi.malhotra@fda.hhs.gov
- PostedDec 10, 2020
- ClosesFeb 18, 2021
- Award floor$250,000
- Award ceiling$500,000
- Expected awards3
- CFDA93.103
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