PE consideration [Regulatives / Guidelines]

posted by Dr_Dan  – Germany, 2013-09-11 14:07 (4672 d 11:05 ago) – Posting: # 11475
Views: 8,647

Dear Jay
what about the third parameter, the intended power?
Formulation difference  5%, CV% 25,   intended Power 80% ⇒ n=28
Formulation difference  5%, CV% 27.5, intended Power 80% ⇒ n=34
Formulation difference  5%, CV% 25,   intended Power 90% ⇒ n=38
Formulation difference 10%, CV% 25,   intended Power 80% ⇒ n=56
Formulation difference 10%, CV% 27.5, intended Power 90% ⇒ n=92

At the end you have to perform a risk/cost evaluation.
Kind regards
Dan

Kind regards and have a nice day
Dr_Dan

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,572 registered users;
353 visitors (0 registered, 353 guests [including 20 identified bots]).
Forum time: 01:13 CEST (Europe/Vienna)

Don’t compromise yourself.
You are all you’ve got.    Janis Joplin

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