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ssussu
Junior

China,
2017-09-22 07:40

Posting: # 17824
Views: 2,133
 

 Pivotal 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!
ElMaestro
Hero

Denmark,
2017-09-22 07:46

@ ssussu
Posting: # 17825
Views: 1,767
 

 Pivotal BE trial power not enough to 0.8

Hi Ssussu,

» (...) 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. :-)

if (3) 4

Best regards,
ElMaestro

"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.
ssussu
Junior

China,
2017-09-22 09:21

@ ElMaestro
Posting: # 17826
Views: 1,748
 

 Pivotal BE trial power not enough to 0.8

Dear ElMaestro,

» Pat yourself on the shoulder. :-)

Thank you so much! So glad to hear that!
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