Intra Subject Variability [Power / Sample Size]

posted by ElMaestro  – Denmark, 2011-03-14 10:19 (5572 d 19:31 ago) – Posting: # 6757
Views: 4,773

Hello Alpesh Ramani,

❝ Intrasubject CV is molecule property or its' also affected by formulation property?


Both.

❝ As everybody know that % CV is used to calculate the sample size. So it is always a matter of confusion with % CV take for sample size calculation for next study, i.e., First pilot, recent study or literature based CV.


There is no easy answer. I would use the CV-value that appears most trustworthy from your source material. Age of study, apparent standard of conduct, and N would all play a role. I would not pool studies, but that of course is a personal and subjective comment.

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
23,654 posts in 4,992 threads, 1,571 registered users;
146 visitors (0 registered, 146 guests [including 16 identified bots]).
Forum time: 06:51 CEST (Europe/Vienna)

Always listen to experts.
They’ll tell you what can’t be done and why.
Then do it.    Robert A. Heinlein

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