Rules acc. to Health Canada [Outliers]

posted by Ohlbe – France, 2019-02-05 15:54 (803 d 15:31 ago) – Posting: # 19870
Views: 4,849

Dear Helmut,

» Do I understand the guidance correctly: I’m not allowed to exclude the pAUC of the outlying subject cause the other metrics are fine?

Interesting. Well, pAUC was added to the guidance in June 2018, but the section on outliers was already there. Not sure that they considered all implications when they revised the guidance. Maybe it would be worth contacting Health Canada to ask for a confirmation ? They may have only had Cmax and AUCt in mind when this paragraph was written ?

Regards
Ohlbe

Complete thread:

Activity
 Admin contact
21,419 posts in 4,475 threads, 1,510 registered users;
online 9 (0 registered, 9 guests [including 3 identified bots]).
Forum time: Monday 08:25 CEST (Europe/Vienna)

There is one certainty in drug development
and statistics that one can depend on:
the data are always late.    Scott Patterson and Byron Jones

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