Transformation, acceptance range [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-03-02 15:09 (690 d 05:30 ago) – Posting: # 19984
Views: 3,700

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

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