OpportunityTitle: Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Not Allowed)
AdditionalInformationOnEligibility: Higher Education InstitutionsPublic/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 EducationNonprofits 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 OrganizationsSmall Businesses For-Profit Organizations (Other than Small Businesses) GovernmentsState 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 OtherIndependent 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 support the research and development necessary to advance non-invasive (e.g., quantitative tomography-based) technologies, including the development of apparatus, methods, study designs, and methods of data analysis, to characterize and compare the rate and extent to which a topically applied drug becomes available at or near a site of action within the skin. The expectation is that the funded work will produce an accurate, sensitive and reproducible approach that rapidly measures the (relative) amount of drug present in the skin at a series of depths below the skin surface, which can be utilized to monitor the cutaneous pharmacokinetics (PK) of the drug at selected depths (e.g., in the epidermis and dermis) by repeated, serial measurements over time. The intent is to support the eventual development of an alternative, scientifically valid, cutaneous PK-based approach that can be used to efficiently demonstrate the bioequivalence (BE) of topical products.
GrantorContactEmailDescription: work email
GrantorContactText: Shashi Malhotra &lt;br/&gt;Grants Management Specialist &lt;br/&gt;Phone 240-402-7592