CVwr and Swr [RSABE / ABEL]

posted by Jay – India, 2016-06-22 12:37 (3152 d 20:09 ago) – Posting: # 16436
Views: 7,151

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

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