Bioequivalence and Bioavailability Forum • Pivotal BE trial power not enough to 0.8

ssussu
☆

China,
2017-09-22 09:40
(3190 d 19:44 ago)

Posting: # 17824
Views: 6,428

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
★★★

Denmark,
2017-09-22 09:46
(3190 d 19:38 ago)

@ ssussu
Posting: # 17825
Views: 5,226

Pivotal BE trial power not enough to 0.8

Post reply

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. :-)

—
Pass or fail!
ElMaestro

ssussu ☆ China, 2017-09-22 11:21 (3190 d 18:03 ago) @ ElMaestro Posting: # 17826 Views: 5,266	Pivotal BE trial power not enough to 0.8 Post reply
	Dear ElMaestro, ❝ Pat yourself on the shoulder. Thank you so much! So glad to hear that!