Subject exclusion [Outliers]

posted by Ohlbe – France, 2018-10-02 23:30 (2089 d 16:12 ago) – Posting: # 19396
Views: 7,037

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:

UA Flag
Activity
 Admin contact
23,059 posts in 4,841 threads, 1,649 registered users;
39 visitors (0 registered, 39 guests [including 3 identified bots]).
Forum time: 15:42 CEST (Europe/Vienna)

There are only two kinds of scholars;
those who love ideas and those who hate them.    Emile Chartier

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