Exclusion of Outlier Data [Outliers]

posted by surajpatel – India, 2021-05-27 08:14 (245 d 02:05 ago) – Posting: # 22369
Views: 782

Hi,

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. Thanks.

Suraj

Complete thread:

Activity
 Admin contact
21,854 posts in 4,573 threads, 1,554 registered users;
online 9 (0 registered, 9 guests [including 9 identified bots]).
Forum time: Thursday 09:19 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
HTML5