Subject exclusion [Outliers]

posted by Ohlbe – France, 2018-10-02 21:30 (1119 d 07:17 ago) – Posting: # 19396
Views: 5,309

Dear Mohamed,

» My question is: when we calculate the geometric mean of the reference auc, shall we include the subject we want to inspect in the calculation of the geometric mean or we shall remove it first before making the calculation?

The guideline is clear on this point:
A subject is considered to have very low plasma concentrations if its AUC is less than 5% of reference medicinal product geometric mean AUC (which should be calculated without inclusion of data from the outlying subject).

Regards
Ohlbe

Complete thread:

Activity
 Admin contact
21,757 posts in 4,549 threads, 1,544 registered users;
online 6 (0 registered, 6 guests [including 4 identified bots]).
Forum time: Tuesday 04:48 CEST (Europe/Vienna)

I have never in my life learned anything
from any man who agreed with me.    Dudley Field Malone

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