Subject exclusion [Outliers]

posted by Ohlbe – France, 2018-10-02 23:30 (2328 d 11:49 ago) – Posting: # 19396
Views: 7,942

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
23,381 posts in 4,914 threads, 1,662 registered users;
36 visitors (0 registered, 36 guests [including 9 identified bots]).
Forum time: 10:19 CET (Europe/Vienna)

Science is built up with facts, as a house is with stones.
But a collection of facts is no more a science
than a heap of stones is a house.    Henri Poincaré

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