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Registerinterpretation of treatment effect [General Statistics]
Hi madhurak,
In my opinion this is a slightly wrong kind of thinking.
There certainly is a relationship between treatment effect and the confidence interval (significant treatment, CI not including 1.0). However, as has been pointed out before, a significant treatment effect is not in itself a cause of rejection. The important question if not whether your formulation differs form the originator's, rather the important question is if it differs to an extent that is important, and the latter is what the regulatory acceptance limits dictate.
EM.
❝ then is it true that treatment effect do not have any impact on confidence interval of Cmax, AUCt, AUCinf.
In my opinion this is a slightly wrong kind of thinking.
There certainly is a relationship between treatment effect and the confidence interval (significant treatment, CI not including 1.0). However, as has been pointed out before, a significant treatment effect is not in itself a cause of rejection. The important question if not whether your formulation differs form the originator's, rather the important question is if it differs to an extent that is important, and the latter is what the regulatory acceptance limits dictate.
EM.
Complete thread:
- interpretation of treatment effect madhurak 2009-08-20 07:58
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- treatment effect p<0.05 Helmut 2009-08-20 15:12
- interpretation of treatment effect madhurak 2009-08-21 06:34
- interpretation of treatment effectElMaestro 2009-08-29 16:54
Ing. Helmut Schütz