Bioequivalence and Bioavailability Forum

Transformation, acceptance range [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2019-03-02 16:09 (1875 d 20:39 ago) – Posting: # 19984
Views: 5,358

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 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Complete thread:

• History lessons - FDA BE 90% CI jag009 2019-02-25 22:03 
  • History lessons - FDA BE 90% CI nobody 2019-02-25 22:39
    • History lessons - FDA BE 90% CI Helmut 2019-02-26 00:44
      • History lessons - FDA BE 90% CI jag009 2019-02-26 15:19
        • History lessons - FDA BE 90% CI nobody 2019-02-26 16:07
        • Strange result Helmut 2019-02-28 12:03
          • Strange result nobody 2019-03-01 08:50
            • Pandora's box? jag009 2019-03-01 17:40
              • Confusing Helmut 2019-03-02 15:37
          • Strange result jag009 2019-03-01 17:44
            • Transformation, acceptance rangeHelmut 2019-03-02 15:09
              • Transformation, acceptance range nobody 2019-03-02 16:42