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RegisterPivotal BE trial power not enough to 0.8 [Power / Sample Size]
Dear all,
I have a question about power of BE study to consulate. When we conducted a pilot trial,we got intrasubject CV and GMR data by which we calculated sample size for pivotal BE study. But， 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?
Thank you!
I have a question about power of BE study to consulate. When we conducted a pilot trial,we got intrasubject CV and GMR data by which we calculated sample size for pivotal BE study. But， 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?
Thank you!
Complete thread:
- Pivotal BE trial power not enough to 0.8ssussu 2017-09-22 07:40
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- Pivotal BE trial power not enough to 0.8 ElMaestro 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 0.8 ElMaestro 2017-09-22 07:46
Ing. Helmut Schütz