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RegisterCVwr and Swr [RSABE / ABEL]
Dear all,
As per EMA guidelines, it is mentioned that 'For the acceptance interval to be widened the bioequivalence study must be of a replicate design where it has been demonstrated that the within-subject variability for Cmax of the reference compound in the study is >30%'
So, for widening of CI what should be considered CVwr (intra-subject variability of reference product) or Swr (within-subject standard deviation)!
Regards,
Jay
As per EMA guidelines, it is mentioned that 'For the acceptance interval to be widened the bioequivalence study must be of a replicate design where it has been demonstrated that the within-subject variability for Cmax of the reference compound in the study is >30%'
So, for widening of CI what should be considered CVwr (intra-subject variability of reference product) or Swr (within-subject standard deviation)!
Regards,
Jay
Complete thread:
- CVwr and SwrJay 2016-06-22 10:37 [RSABE / ABEL]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- CVwr for switching to widening d_labes 2016-06-22 15:24
- CVwr and Swr DavidManteigas 2016-06-23 10:52
Ing. Helmut Schütz