Bioequivalence and Bioavailability Forum

Hi Brus,

❝ But nothing is said about the option full-replicate 3-ways, 2-sequences: TRT / RTR,……

Stupid enough. We may run into trouble if we have to assess the study in a partial replicate design for ABE because \(\small{s_\text{wR} < 0.294}\). See this article. At a webinar in March 2023 I tried to ask Donald Schuirmann.
The 👨‍✈️ steering moderating the »Panel Dis­cus­sions« decided to ignore my question… Instead, the only question related to SABE was “How is a Highly Variable Drug defined?”, which Donald explained at great length. Oh dear, what a waste of time!

❝ … which does seem to be included in the guideline Statistical Approaches to Establishing Bio­equi­valence.

Pragmatic: This one is the newest one.

❝ Does this mean that this design can no longer be used?

I don’t see any reason for not doing so. Why should we use an inferior method in lieu of a better one? If in doubt, initiate a controlled correspondence with the .