Adhesion Score Analysis [Design Issues]

posted by durga09 – India, 2023-07-17 13:15 (364 d 16:22 ago) – Posting: # 23672
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Dear All,

Could anyone please help me with example or article or program, how to calculate below points for adhesion score based on the guideline Assessing adhesion with transdermal and Topical delivery systems for ANDAs guidance for industry
  1. Proportion of subjects with an observed adhesion score ≥2 at any time point, compared between T and R.
  2. Proportion of subjects with their T mean adhesion score greater than the corresponding R mean adhesion score by 1 or more, compared to the proportion of subjects with their R mean adhesion score greater than the corresponding T mean adhesion score by 1 or more.
  3. Time to an observed adhesion score ≥2 compared between T and R. If there are a sufficient number of events, a Kaplan Meier cumulative incidence curve can be plotted.

Regards,
Durga

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