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FDA -- Bioequivalence of Topical Products: Elucidating the Sensorial and Functional Characteristics of Compositionally Different 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 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.
- Letter of Intent Due Date(s): February 25, 2019
- Application Due Date(s): April 11, 2019
RFA-FD-19-009 Expiration Date April 12, 2019
Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):
YR 01: $500,000
YR 02: $500,000