OpportunityTitle: Renewal - Elucidating the Sensorial and Functional Characteristics of Compositionally Different and Differently Aged Topical Formulations (U01) Clinical Trial Required
AdditionalInformationOnEligibility: Eligible Organizations  &#183;        University of Queensland       Foreign Institutions  Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.  Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.  Foreign components, as defined in the HHS Grants Policy Statement, are allowed.
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 (therapeutic) properties, as well as the impact of product aging on those properties. The goal is to characterize the relevant physicochemical and structural properties of topical semisolid formulations/products to assess (and predict) whether test and reference products that may be compositionally different are likely to provide a comparable sensory experience to a patient (including comparable perceptions of grittiness, silky-smoothness, and cooling sensation) which may impact the therapeutic equivalence of the drug products.
GrantorContactEmailDescription: shashi.malhotra@fda.hhs.gov
GrantorContactText: Shashi Malhotra &lt;br/&gt;Grants Management Specialist &lt;br/&gt;Phone 2404027592