OpportunityTitle: Physiologically-based pharmacokinetic (PBPK) models to aid the development of generic dermatological products (U01) Clinical Trials Optional
AdditionalInformationOnEligibility: Higher Education Institutions&#183;        Public/State Controlled Institutions of Higher Education &#183;        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&#183;        Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) &#183;        Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations&#183;        Small Businesses &#183;        For-Profit Organizations (Other than Small Businesses) Governments&#183;        State Governments &#183;        County Governments &#183;        City or Township Governments &#183;        Special District Governments &#183;        Indian/Native American Tribal Governments (Federally Recognized) &#183;        Indian/Native American Tribal Governments (Other than Federally Recognized) &#183;        U.S. Territory or Possession Other&#183;        Independent School Districts &#183;        Public Housing Authorities/Indian Housing Authorities &#183;        Native American Tribal Organizations (other than Federally recognized tribal governments) &#183;        Faith-based or Community-based Organizations &#183;        Regional Organizations &#183;        Non-domestic (non-U.S.) Entities (Foreign Institutions)
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.
GrantorContactEmailDescription: shashi.malhotra@fda.hhs.gov
GrantorContactText: Shashi Malhotra &lt;br/&gt;Grants Management Specialist &lt;br/&gt;Phone 2404027592