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Panelist: sample entire roll and consider both length and width for transdermal cohort sampling
Summary
Dr. Kokate said coat weight is an important in-process control for transdermal systems and recommended sampling that covers the full roll length and width, with at least one roll tested and additional rolls as needed.
An online attendee asked Dr. Kokate to elaborate on cohort sampling strategy shown on slide 10, specifically test frequency and sampling locations for transdermal systems.
Dr. Kokate said that coat weight is an important in-process control for transdermal systems and recommended test frequency that covers the entire roll process. He suggested that the minimal requirement is to test at least one roll and, if multiple rolls are produced, applicants should consider sampling across the length and width of each roll to capture variability.
The guidance was procedural and aimed at helping applicants design in-process controls and sampling plans; no formal policy change was announced during the session.
