[membership level=”0,4″][The content continues for paid members only.]
Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership]
CDER has released a draft guidance providing recommendations for the design and conduct of studies for evaluating the adhesive performance of a transdermal delivery system (TDS) or a topical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.
[/membership]
INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
