Transformation, acceptance range [Regulatives / Guidelines]
Hi John,
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
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).
❝ ❝ 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.

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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Complete thread:
- History lessons - FDA BE 90% CI jag009 2019-02-25 22:03 [Regulatives / Guidelines]
- 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
- Pandora's box? jag009 2019-03-01 17:40
- 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
- Transformation, acceptance rangeHelmut 2019-03-02 15:09
- Strange result nobody 2019-03-01 08:50
- History lessons - FDA BE 90% CI jag009 2019-02-26 15:19
- History lessons - FDA BE 90% CI Helmut 2019-02-26 00:44
- History lessons - FDA BE 90% CI nobody 2019-02-25 22:39