Bioequivalence and Bioavailability Forum

Dear Dr_Dan,

page 22 of the holy scripture provides guidance.
Apart from blahblah the most important sentence in my opinion is "Bioequivalence studies should be conducted according to the recommended use of the product."

If the vols have never used such formulations before or are study-naïve they may be a bit nervous in the first period (or at least more nervous in the first than in the second). This may cause dry mouth in the first period but less so in the next etc, and can affect disperison time and thus add spurious variation. To minimise variation a bit of training therefore could be relevant.