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Dear Frieda,
IMHO:
What you do is to look for differences (and explanations for it) which you consider in your first test (the bioequivalence test using the 90% CIs) as not important enough and not contradictory to the equivalence hypothesis.
This is illogical to me.
I have seen in my carrier a lot of such analysis but in the context of failed superiority trials seeking for reasons of that and seeking for subgroups with effect present.
All of them useless, at least in a regulatory sense.
❝ The ratio T to R for AUCtau on the last dosing day (n=21) was 0.89, 90% CI 0.85 to 0.94; similar values were obtained for Cmax. Although the 90%CI falls within 0.80-1.25, 1.0 is not included so I looked at the data in more detail, mostly plots and geometric means for the two treatment sequences, and this seemed to point at a sequence effect ...
IMHO:
What you do is to look for differences (and explanations for it) which you consider in your first test (the bioequivalence test using the 90% CIs) as not important enough and not contradictory to the equivalence hypothesis.
This is illogical to me.
I have seen in my carrier a lot of such analysis but in the context of failed superiority trials seeking for reasons of that and seeking for subgroups with effect present.
All of them useless, at least in a regulatory sense.
—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- How to deal with a sequence effect? Frieda 2008-08-01 14:36
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- How to deal with a sequence effect? ElMaestro 2008-08-01 16:36
- How to deal with a sequence effect? Frieda 2008-08-06 09:57
- PK interaction studies Helmut 2008-08-01 18:58
- PK interaction studies Frieda 2008-08-06 18:35
- How to deal with a sequence effect?d_labes 2008-08-04 09:23
- How to deal with a sequence effect? Frieda 2008-08-06 13:49
- How to deal with a sequence effect? Helmut 2008-08-10 14:25
- How to deal with a sequence effect? d_labes 2008-08-11 14:50
- How to deal with a sequence effect? Helmut 2008-08-11 16:33
- actio est reactio d_labes 2008-08-12 09:55
- actio est reactio Helmut 2008-08-12 12:36
- actio est reactio d_labes 2008-08-12 09:55
- How to deal with a sequence effect? Helmut 2008-08-11 16:33
- How to deal with a sequence effect? d_labes 2008-08-11 14:50
- How to deal with a sequence effect? ElMaestro 2008-08-01 16:36
Ing. Helmut Schütz