Bioequivalence and Bioavailability Forum

Dear all,

I also have some questions on this paper because I'm not that familiar with these procedures yet (sorry...). First they describe the method of EMA and state that this is "still Average Bioequivalence but with Expanding Limits" (and thus "the TOST procedure of Schuirmann can be directly applied"). Later they say that FDA uses scaled average BE instead, but for me equation [5] does not really differ from [3] and therefore (at this point) I don't understand why SABE is different from ABEL. (And hence I don't understand why the TOST procedure cannot be applied). Since the equation was equivalently restated from [3] to [5] this makes the impression – at least for me – that we have two different words (namely ABEL and SABE) for the same procedure. But I guess it's not supposed to be like this?! (BTW: the lower bound of equation [5] should be -k and not k, shouldn't it? 'cause otherwise (m_T-m_R)/s_w equals k). So where is the substantial difference here (apart of course from the additional conditions required by EMA or FDA and the different choice of k or sigma_0)?

Thank you,
Ben