Subject exclusion [Outliers]

posted by Mohamed Yehia  – Egypt, 2018-10-03 00:18 (1706 d 01:20 ago) – Posting: # 19400
Views: 5,888

Dear Ohlbe,

❝ The guideline does not ask for any statistical outlier test to be performed. If you have a subject with very low concentrations, calculate the geometric mean of the AUC of the reference without that subject. If the AUC of the subject for the reference product is lower than 5 % of that mean you have a possibility to exclude him. That's all.


It is stated that we have to remove outlier subjects for reference auc before making th geometric mean calculation. So I think that we have to include all the subjects inckuding the one we want to check and check for the outlier first and in case there is no outlier we then calculate the geometric mean and check for 5 %.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]

Complete thread:

UA Flag
Activity
 Admin contact
22,616 posts in 4,740 threads, 1,613 registered users;
25 visitors (0 registered, 25 guests [including 14 identified bots]).
Forum time: 01:38 CEST (Europe/Vienna)

Biostatistician. One who has neither the intellect for mathematics
nor the commitment for medicine but likes to dabble in both.    Stephen Senn

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