Bioequivalence and Bioavailability Forum

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