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CDER has released a draft guidance providing recommendations for the design and conduct of studies for evaluating the adhesive performance of a transdermal delivery system (TDS) or a topical patch that are submitted in support of ANDAs. The draft notes that the guidance supersedes the recommendations related to adhesion studies provided in individual product-specific guidances. Discussed are the adhesion scoring system, study design and conduct, statistical analysis, bioequivalence, and format of data submission.
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