Exclusion of Outlier Data [Outliers]

posted by surajpatel – India, 2021-05-27 08:14 (445 d 01:00 ago) – Posting: # 22369
Views: 977

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:

UA Flag
Activity
 Admin contact
22,301 posts in 4,667 threads, 1,585 registered users;
online 10 (0 registered, 10 guests [including 4 identified bots]).
Forum time: Monday 09:14 CEST (Europe/Vienna)

Science… never solves a problem
without creating ten more.    George Bernard Shaw

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