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RegisterPivotal BE trial power not enough to 0.8 [Power / Sample Size]
Hi Ssussu,
Yes you have shown BE. Every guidance I can think of supports that conclusion, mainly because sample size calculation via power is based on an assumption about GMR and CV prior to the trial itself. Whether that assumption seems to hold true once the trial has been conducted is immaterial for the comparability; what is important is the confidence interval itself.
Pat yourself on the shoulder.
❝ (...) unluckily, the intrasubject CV from pivotal BE trial was larger than pilot trial, however, CI90 and point estimate were totally met the acceptance of Bioequivalence,only except the powerTOST from pivotal trial was less than 0.8.
❝ Then, in this situation, can i make conclusion of bioequivalence? Is there any guidance to support my conclusion?
Yes you have shown BE. Every guidance I can think of supports that conclusion, mainly because sample size calculation via power is based on an assumption about GMR and CV prior to the trial itself. Whether that assumption seems to hold true once the trial has been conducted is immaterial for the comparability; what is important is the confidence interval itself.
Pat yourself on the shoulder.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Pivotal BE trial power not enough to 0.8 ssussu 2017-09-22 07:40 [Power / Sample Size]
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- Pivotal BE trial power not enough to 0.8ElMaestro 2017-09-22 07:46
- Pivotal BE trial power not enough to 0.8 ssussu 2017-09-22 09:21
- Pivotal BE trial power not enough to 0.8ElMaestro 2017-09-22 07:46
Ing. Helmut Schütz