sample size for BA/BE studies [Regulatives / Guidelines]

posted by drmuneesh – 2008-11-17 15:10 (6416 d 21:44 ago) – Posting: # 2692
Views: 9,361

Dear Ohlbe

In continuation to your reply, we have done a pilot study with 11 subjects and results from the pilot study are as follows:

intra subject CV: 0.166203

%T/R Ratio for Cmax: 115.89

and we want to calculate sample size for pivotal study. Now my query is that should we consider only the Intra-subject CV or both the Intra-subject CV and T/R ratio observed from the pilot study or the expected T/R ratio (0.95-1.05) to calculate the sample size.

Because if we consider both the Intra-subject CV and observed T/R ratio, sample size comes much more than what is coming from considering only the Intra-subject CV.

Please guide us what is the globally accepted method of calculating sample size.

Best Regards

Dr Muneesh

Complete thread:

UA Flag
Activity
 Admin contact
23,653 posts in 4,991 threads, 1,570 registered users;
106 visitors (0 registered, 106 guests [including 22 identified bots]).
Forum time: 13:54 CEST (Europe/Vienna)

To propose that poor design can be corrected by subtle analysis techniques
is contrary to good scientific thinking.    Stuart J. Pocock

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