Strange result [Regulatives / Guidelines]

posted by jag009  – NJ, 2019-03-01 17:44 (528 d 19:58 ago) – Posting: # 19983
Views: 3,285

Hi Helmut!

» Was the study performed for Health Canada? In the 1989 draft 80–120% (untransformed data) were recommended and changed to 80–125% (log-transformed) in 1991.
» Then the study would have passed again cause –18.33% > –20% and –6.36% < +20%. However, the problem with the PE persists cause 100(–0.1833 + (–0.0636)) / 2 = –12.35% ≠ –6.14%. I don’t get it.

That I do not know (if it's for Canada) but it was a us study w US products. But your suggestion about Canada using non-transformed make sense(?) Can you tell me (or pt to me) about the Canadian guidance 89?

Thanks
J

Complete thread:

Activity
 Admin contact
21,000 posts in 4,378 threads, 1,460 registered users;
online 20 (1 registered, 19 guests [including 12 identified bots]).
Forum time: Tuesday 14:43 CEST (Europe/Vienna)

Average a left-hander with a right-hander
and what do you get?    Donald Norman

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