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

posted by ssussu – China, 2017-09-22 09:40 (2379 d 06:47 ago) – Posting: # 17824
Views: 4,391

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!

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,638 registered users;
73 visitors (0 registered, 73 guests [including 8 identified bots]).
Forum time: 15:27 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5