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Jay ☆ India, 2016-06-22 12:37 (3656 d 16:48 ago) Posting: # 16436 Views: 9,058 |
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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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d_labes ★★★ Berlin, Germany, 2016-06-22 17:24 (3656 d 12:01 ago) @ Jay Posting: # 16443 Views: 7,825 |
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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 |
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DavidManteigas ★ Portugal, 2016-06-23 12:52 (3655 d 16:33 ago) @ Jay Posting: # 16451 Views: 7,741 |
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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. |
Ing. Helmut Schütz