OpportunityTitle: Quantify the expression of metabolizing enzymes and transporter proteins in lung, eye and skin tissue in relevant animal models and humans (U01) Clinical Trial Not Allowed
AdditionalInformationOnEligibility: Eligible Organizations  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)
Description: The purpose of this funding opportunity is to systematically quantify the protein levels of potential metabolizing enzymes and transporters in rabbit and human eye tissue, human lung tissue, and human skin tissue using most advanced techniques, where individual proposals will select one research area (i.e., ophthalmic, dermal, or pulmonary). Subsequently, the experimental data collected from this study will be implemented into existing modeling platforms to allow for virtual bioequivalence (BE) assessments locally and systemically for the parent and pharmacologically active metabolite.
GrantorContactEmailDescription: shashi.malhotra@fda.hhs.gov
GrantorContactText: Shashi Malhotra &lt;br/&gt;Grants Management Specialist &lt;br/&gt;Phone 2404027592