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

posted by drmuneesh – 2008-11-19 11:14 (6411 d 19:57 ago) – Posting: # 2730
Views: 9,186

Dear EM

Suppose I have done a two-way cross-over pilot study and I have calculated the sample size for the pivotal study considering intra-subject CV and observed %T/R ratio using SAS. The sample size calculated is X. As SAS gives sample size for two-way cross-over study, right? If the intra-subject CV is > 30% and the drug is known to be highly variable and therefore, I want to use the replicate study design, in that case can I do the study with half the number of subjects i.e dividing the calculated sample size by 2 (X/2).

I have done a pilot study with parallel design and I have calculated the sample size for the pivotal study considering CV and observed %T/R ratio using SAS. The sample size calculated is X. As SAS gives sample size for two-way cross-over study, right? In that case can I do the study with double the number of subjects i.e multiplying the calculated sample size by 2 (2X).

Please suggest.

Best Regards

Dr Muneesh Garg

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