Jay
☆    

India,
2016-06-22 12:37
(2837 d 02:10 ago)

Posting: # 16436
Views: 6,091
 

 CVwr 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
d_labes
★★★

Berlin, Germany,
2016-06-22 17:24
(2836 d 21:23 ago)

@ Jay
Posting: # 16443
Views: 5,327
 

 CVwr for switching to widening

Dear Jay,

❝ So, for widening of CI what should be considered CVwr (intra-subject variability of reference product) or Swr (within-subject standard deviation)!


Simple answer: CVwr > 30%.

SwR = sqrt(log(1+CV*CV)) if CV is given as ratio,
means SwR = 0.2935604 if CV=0.3

Regards,

Detlew
DavidManteigas
★    

Portugal,
2016-06-23 12:52
(2836 d 01:55 ago)

@ Jay
Posting: # 16451
Views: 5,279
 

 CVwr and Swr

Dear Jay,

Please, consider that for applying this criteria you must pre-specify in your Protocol and your design must be, at least, partial replicate (2X3X3 - that is, the reference must be administered twice). Also, for Europe only Cmax acceptance criteria could be widened. If you already conducted your study as a 2x2x2 there is nothing you can do regarding the acceptance criteria.
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