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

posted by drmuneesh – 2008-11-19 11:14 (6057 d 14:03 ago) – Posting: # 2730
Views: 7,952

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

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,672 registered users;
46 visitors (0 registered, 46 guests [including 9 identified bots]).
Forum time: 02:17 CEST (Europe/Vienna)

Medical researches can be divided into two sorts:
those who think that meta is better and those
who believe that pooling is fooling.    Stephen Senn

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