Bioequivalence and Bioavailability Forum

Dear colleagues,

Concurrent to our efforts in calculating the sample size for the BE of fixed dose combination preparations, may I request for your opinion/insight on how best to determine the sample size needed to achieve the desired power of the study, particularly, if one active drug is identified or reported in the literature as highly variable (intra-subject CV >30%) and the other active drug is not highly variable.

Thanks for the kind help.