Strange result [Regulatives / Guidelines]

posted by jag009  – NJ, 2019-03-01 18:44 (2313 d 06:57 ago) – Posting: # 19983
Views: 7,042

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:

UA Flag
Activity
 Admin contact
23,425 posts in 4,928 threads, 1,681 registered users;
54 visitors (0 registered, 54 guests [including 9 identified bots]).
Forum time: 02:42 CEST (Europe/Vienna)

Fools with Tools Are Still Fools!    Anonymous

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