Bioequivalence and Bioavailability Forum

Hi Helmut,

thanks for posting. I think this is a step in the right direction. To me meffud B and C are pretty similar in terms of the work needed to plan and conduct the study, and since the two meffuds have nearly equal performance I have little or no preference myself. I am just happy FDA is giving one of them the green light.

Now we just need some considerations over stoping criteria and higher target power than 80% and oooohh aaah parallel studies.

Have a great day.