Strange result [Regulatives / Guidelines]

posted by jag009  – NJ, 2019-03-01 17:44  – Posting: # 19983
Views: 1,721

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
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,880 posts in 4,214 threads, 1,364 registered users;
online 5 (0 registered, 5 guests [including 3 identified bots]).
Forum time (Europe/Vienna): 03:20 CEST

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder.    Laurence J. Peter

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5