Revalidate the study [Study As­sess­ment]

posted by Ken Peh – Malaysia, 2014-07-20 19:01 (2466 d 02:18 ago) – Posting: # 13276
Views: 6,384

Dear Members,

We ran a BE study on 24 subjects. Unfortunately, on the day of study, two subjects dropped out and 7 subjects worked night shift and could only reported to the trial site after midnight. We were told that the 7 subjects could not be considered as these subjects could not be proven to have fasted. The study passed with 15 subjects and CVintrasubject of AUC and Cmax were below 10%.

We were asked to revalidate the study since the power of study should be 24 subjects. How do we revalidate the study ? Can we use the posthoc CV to show that the power is more than 80% even with 15 subjects ?

Highly appreciate your comments.

Thank you.

Regards,
Ken


Edit: Category changed. [Helmut]

Complete thread:

Activity
 Admin contact
21,419 posts in 4,475 threads, 1,509 registered users;
online 9 (0 registered, 9 guests [including 5 identified bots]).
Forum time: Tuesday 21:19 CEST (Europe/Vienna)

We have to remember that what we observe is not nature herself,
but nature exposed to our method of questioning.    Werner Heisenberg

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