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

posted by drmuneesh – 2008-11-17 15:10 (6060 d 17:31 ago) – Posting: # 2692
Views: 8,127

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

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