Subject exclusion [Outliers]

posted by Mohamed Yehia  – Egypt, 2018-10-02 23:25 (2060 d 05:56 ago) – Posting: # 19395
Views: 7,549

Hi All,

Concerning what stated in EMEA guidelines, if auc of reference cmax of certain subject is less than 5% of the geometric mean, the subject is excluded.

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?

Thanks.


Edit: Category changed; see also this post #1[Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
23,035 posts in 4,835 threads, 1,645 registered users;
55 visitors (0 registered, 55 guests [including 4 identified bots]).
Forum time: 05:22 CEST (Europe/Vienna)

The mediocre teacher tells.
The good teacher explains.
The superior teacher demonstrates.
The great teacher inspires.    William Arthur Ward

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