Exclusion of Outlier Data [Outliers]

posted by drgunasakaran1  – 2021-05-27 08:58 (395 d 08:14 ago) – Posting: # 22370
Views: 826

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:

UA Flag
Activity
 Admin contact
22,171 posts in 4,646 threads, 1,570 registered users;
online 13 (2 registered, 11 guests [including 8 identified bots]).
Forum time: Sunday 17:12 CEST (Europe/Vienna)

The person interested in success has to learn
to view failure as a healthy, inevitable part
of the process of getting to the top.    Joyce Brothers

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