Transformation, acceptance range [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-03-02 15:09 (737 d 08:11 ago) – Posting: # 19984
Views: 3,801

Hi John,

» » 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.
»
» But your suggestion about Canada using non-transformed make sense(?) Can you tell me (or pt to me) about the Canadian guidance 89?

Another goody: At the “International Open Conference on Dissolution, Bioavailability, Bioequivalence” (Toronto, June 15–17, 1992) the current draft was provided (without a date), which stated

95% CI of relative mean AUC 80%–125%.

John Ruedy (Chairman, Expert Advisory Committee of Biovailability, HC’s HPB) pointed out in his presentation that the final guidance will require a 90% CI.
Couldn’t find the pre-1992 guidance so far. :-( Maybe my memory mixed the transformation-business up with this story (see the end of this post).

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
21,372 posts in 4,463 threads, 1,495 registered users;
online 3 (1 registered, 2 guests [including 2 identified bots]).
Forum time: Monday 23:20 CET (Europe/Vienna)

When puzzled, it never hurts to read the primary documents 
a rather simple and self-evident principle that has, nonetheless,
completely disappeared from large sectors
of the American experience.    Stephen Jay Gould

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