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RegisterBE with 1 not included in CI -danish twist [RSABE / ABEL]
My dear!
Did you really forgot the Danish twist? Although the power calculation for their "BE decision rule" was implemented in the famous EFG? Can't believe that
.
@Coja:
Your BE acceptance range is really wide. Where did it came from?
If your study is aimed for the European market no go! The widest acceptance range allowed in the EMA guidance is 69.84% ... 143.19% given that your study is a replicate crossover study and your intra-subject CV of the Reference from that study is >=50%. Note that the widening is only allowed for Cmax.
If your study is targeted to the FDA a simple widening of the acceptance range is not the correct method. Search the Forum for "scaled average bioequivalence" or "RSABE".
❝ 1.0 not included in the 90% CI should not keep you awake at night.
Did you really forgot the Danish twist? Although the power calculation for their "BE decision rule" was implemented in the famous EFG? Can't believe that
.@Coja:
Your BE acceptance range is really wide. Where did it came from?
If your study is aimed for the European market no go! The widest acceptance range allowed in the EMA guidance is 69.84% ... 143.19% given that your study is a replicate crossover study and your intra-subject CV of the Reference from that study is >=50%. Note that the widening is only allowed for Cmax.
If your study is targeted to the FDA a simple widening of the acceptance range is not the correct method. Search the Forum for "scaled average bioequivalence" or "RSABE".
—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- BE with 1 not included in CI ? Coja66 2013-01-16 10:12
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE with 1 not included in CI ? ElMaestro 2013-01-16 11:38
- BE with 1 not included in CI -danish twistd_labes 2013-01-16 15:07
- BE with 1 not included in CI -danish twist ElMaestro 2013-01-16 17:46
- BE with 1 not included in CI -danish twist The Outlaw Torn 2013-01-17 13:27
- BE with 1 not included in CI -danish twist bjkim97 2013-02-06 05:56
- EMA widenend ABEL d_labes 2013-02-06 09:27
- BE with 1 not included in CI -danish twist ElMaestro 2013-01-16 17:46
- BE with 1 not included in CI -danish twistd_labes 2013-01-16 15:07
- BE with 1 not included in CI ? ElMaestro 2013-01-16 11:38
Ing. Helmut Schütz