Be study with 2 groups [Design Issues]

posted by jag009  – NJ, 2013-08-28 21:23 (4680 d 09:20 ago) – Posting: # 11373
Views: 2,092

Hi all,

Question. Under what circumstances should one not attempt a BE study with more than 1 group of subjects? My thinking is not to run such a study with a highly variable drug (ISCV much greater than 30%) which shows high intersubject variation (no not due to fast and slow metabolizers for example).

If one does conduct such a study, should the sample size be increased in anticipation that if a group effect exists and the BE analysis ends up being performed for each group?

Thanks
John

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