Bioequivalence and Bioavailability Forum

Hi Hötzi,

❝ THX at lot for this gem! Obviously people at the WHO are more clever than the EMA’s 

In actuality, they are for many practical purposes exactly the same people.

❝ Confused? So am I.

There is no point is asking why, I think. They need 4 periods? They specifically seem to want to compare variability for Ref and Test. Are we back to the all the stuff that didn't work 10-20 years ago, population BE and individual BE and such. Obviously not the case. So it is anyones guess what the intent is given the wording.
However, there is plenty useful info in the guidance. Don't let a few inconsistencies spoil the party. Let the scaling for AUCt commence...

It of course comes at a handy time when WHO are opening up for biologics. This isn't a co-incidence .