Exclusion of Outlier Data [Outliers]

posted by drgunasakaran1  – 2021-05-27 08:58 (153 d 04:13 ago) – Posting: # 22370
Views: 610

Dear Mr Suraj,

» We completed fasting bioequivalence study for Health Canada with 28 subjects. 4 subjects are showing outliers (more than 10 times of Cmax from other subjects). Can we exclude these subjects and submit the data to Health Canada. Will they accept after exclusion because the study fails if we include those 4 outliers data or we need to go for re-dosing those 4 subjects and submit the new data.

As per Health Canada Guidance Document on Conduct and Analysis of Comparative Bioavailability Studies "No more than 5% of the subjects may be considered to be outliers, unless there are 20 or fewer subjects. In your case, more than 5% of subjects are falling under the category of outliers.
Also, Re‐testing of subjects identified as outliers is not recommended as per Health Canada"
.

Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.

Complete thread:

Activity
 Admin contact
21,758 posts in 4,550 threads, 1,545 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Wednesday 13:12 CEST (Europe/Vienna)

There ain’t no rules around here!
We’re trying to accomplish something!    Thomas Alva Edison

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