Power in the pivotal study (EU) [Power / Sample Size]

posted by valivetiananth – India, 2018-05-31 13:49 (1245 d 17:33 ago) – Posting: # 18832
Views: 7,258

Dear All,

Greetings!!!

We have conducted a pivotal study for Europe with 48 subjects considering ~80% power, ISCV: 23%. The study was bioequivalent and 90% CI is within 80-125 for both Cmax & AUCt.

Power of Cmax and AUCt are 92% & 66% respectively. Kindly guide us how to justify the power less than 80% to HA.


Thanks
Valiveti

Complete thread:

Activity
 Admin contact
21,760 posts in 4,550 threads, 1,545 registered users;
online 3 (0 registered, 3 guests [including 3 identified bots]).
Forum time: Thursday 07:22 CEST (Europe/Vienna)

Always remember that you are absolutely unique.
Just like everyone else.    Margaret Mead

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