OpportunityTitle: Bioequivalence of Topical Products: Elucidating the Sensorial and Functional Characteristics of Compositionally Different Topical Formulations (U01 Clinical Trial Required)
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 Institutionso   Historically Black Colleges and Universities (HBCUs)o   Tribally Controlled Colleges and Universities (TCCUs) o   Alaska Native and Native Hawaiian Serving Institutionso   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 research relevant to topical semisolid drug products that will help elucidate the relationship between a product&apos;s quality attributes and its functional properties. A specific purpose is to elucidate how characterizations of the arrangement of matter, including rheological characterizations (e.g., texture analysis, tribology) may correlate with and/or be predictive of sensorial differences perceived by human subjects (or patients). Upon the successful completion of this research, it should be possible to predict, based upon product quality characterizations, whether test and reference products that may be compositionally different are likely to have a comparable look and feel, including comparable perceptions of grittiness, silky-smoothness, and cooling sensation.
GrantorContactEmailDescription: Work email
GrantorContactText: Shashi Malhotra &lt;br/&gt;Grants Management Specialist &lt;br/&gt;Phone 2404027592