Bioequivalence and Bioavailability Forum

Dear SriKanth!

For basics of bioequivalence see this post. For planing, conduct, evaluation, etc. see my lectures.

BE studies are always confirmatory (i.e., you want to demonstrate something with given alpha- and beta-errors), whereas BA studies are exploratory (i.e., the results are descriptive only).
Since in BA we don't test a statistical hypothesis, sample size generally is based on rules-by-thumb. Most regulations require a minimum of 12 subjects, but 24-36 are commonly used. Results are generally reported as geometric means (AUC, C_max), median (t_max) together with their 95 % confidence intervals. In BA we are interested in understandig the drug/formulation, therefore the entire arsenal of PK-metrics may be applied (MRT, C_max/AUC, ).
There is a fuzzy border between simple BA- and more complex PK-studies. Whereas the former will be evaluated by NCA-methods only, the latter may call for classical PK-modeling, physiology-based PK and/or population PK.