In Vitro Approaches to Evaluate and Compare the Adhesion Performance of Transdermal and Topical Delivery Systems (TDS) (U01) Clinical Trial Required

The purpose of this funding opportunity is to support the research to develop in vitro test methods for Transdermal and Topical delivery systems (collectively, TDS) that can correlate with and be predictive of TDS adhesion performance in vivo. Differences in product design, formulation, or quality attributes between a prospective generic TDS and it reference TDS may have the potential to alter the adhesion quality or performance of the test TDS, compared to the reference TDS. The in vitro test methods to be developed are expected to be useful for the industry to evaluate potential failure modes related to TDS adhesion during the development of prospective generic TDS, and useful in FDA's assessment of potential differences in the adhesion quality and performance of prospective generic TDS relative to their reference TDS.