Health Canada: read the guidance [Outliers]

posted by Helmut Homepage – Vienna, Austria, 2021-05-27 10:14 (122 d 19:40 ago) – Posting: # 22371
Views: 541

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
[image]

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

Complete thread:

Activity
 Admin contact
21,700 posts in 4,538 threads, 1,542 registered users;
online 4 (0 registered, 4 guests [including 3 identified bots]).
Forum time: Monday 05:54 CEST (Europe/Vienna)

In the beginner’s mind there are many possibilities.
In the expert’s mind there are few.    Shunryu Suzuki

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5