Health Canada: read the guidance [Outliers]

posted by Helmut Homepage – Vienna, Austria, 2021-05-27 12:14 (554 d 12:56 ago) – Posting: # 22371
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Hi Suraj,

adding to Dr S Gunasakaran’s comments:
  1. The procedure to deal with outliers has to be stated in the protocol.
  2. Identification of outliers should be based on a test. ±3 studentized model residuals is recommended. The magnitude of the deviation of the observed values is not relevant.
  3. The procdure should be followed before the study is assessed for BE.
Seemingly you didn’t comply with all of the mentioned conditions.

Next time read the respective guidance before planning the study.

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