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Back to the forum  Query: 2017-10-21 03:02 CEST (UTC+2h)

Pivotal BE trial power not enough to 0.8 [Power / Sample Size]

posted by ssussu - China, 2017-09-22 07:40  - Posting: # 17824
Views: 637

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!

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The difference between a surrogate and a true endpoint
is like the difference between a cheque and cash.
You can get the cheque earlier but then,
of course, it might bounce.    Stephen Senn

BEBAC Ing. Helmut Schütz