Health Canada: read the guidance [Outliers]

posted by Helmut Homepage – Vienna, Austria, 2021-05-27 10:14 (245 d 00:14 ago) – Posting: # 22371
Views: 663

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.

Dif-tor heh smusma 🖖
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

 Admin contact
21,854 posts in 4,573 threads, 1,554 registered users;
online 12 (0 registered, 12 guests [including 8 identified bots]).
Forum time: Thursday 09:29 CET (Europe/Vienna)

Try to learn something about everything
and everything about something.    Thomas Henry Huxley

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz