Rules acc. to Health Canada [Outliers]

posted by Helmut Homepage – Vienna, Austria, 2019-02-05 16:52 (665 d 07:55 ago) – Posting: # 19875
Views: 4,390

Hi Ohlbe,

» […] 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 ?

Maybe. This part of (3) is funny:

Parameters of interest are usually an AUC and Cmax measure, but in some instances other parameters are required.

Others? Wow! I guess they mean additional ones. The only studies I ever have done without AUC and Cmax were for an antibiotic where primary were a set of Occupany times. ;-)
And yes, we are in constant contact with HC. This part slipped through my attention.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
21,226 posts in 4,427 threads, 1,482 registered users;
online 7 (1 registered, 6 guests [including 5 identified bots]).
Forum time: Wednesday 00:47 UTC (Europe/Vienna)

A big data-analyst is an expert
in producing misleading conclusions from huge datasets.
It is much more efficient to use a statistician,
who can do the same with small ones.    Stephen Senn

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