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RegisterBE with 1 not included in CI -danish twist [RSABE / ABEL]
❝ Dear d_labes!
❝ 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.
Why this CV(Intra) is >=50%?
Is this CV(Intra)>=30%?. Is not that widening is more than >=30%?
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 twist d_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 twistbjkim97 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 twist d_labes 2013-01-16 15:07
- BE with 1 not included in CI ? ElMaestro 2013-01-16 11:38
Ing. Helmut Schütz