Bioequivalence and Bioavailability Forum

Hi Nobody,

it is quite simple.
Look at the pilot trial's CI for whatever you are interested in, such as the T/R.

If the CI is for example 60-149 (and it might well be in a pilot. Even for AUC. Even if AUC's CV is not high) then you cannot really take any decision based on the location of T/R. Think about it. For two identical product, you will "quite likely" make the wrong decision whether your decision is.

There was a weirdo who wrote a paper about pilot and repeat trials as development tools in BE. The author's only regret is that he presented the data the way he did. It would have appealed more to the broad audience if he had graphed the chance of taking the wrong decision in the various scenarios when the decision was to be based on the location of the apparent T/R.