Renewal - Elucidating the Sensorial and Functional Characteristics of Compositionally Different and Differently Aged Topical Formulations (U01) Clinical Trial Required

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'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.