Bioequivalence and Bioavailability Forum

Hi all,

a very interesting thread, but also one that has the potential go be blown very quickly out of proportions when things go personal.

It is noteworthy that 7% type I error is acceptable when doing scaling in EU but not when doing other types of BE. As my brain is only walnut-sized I may have missed something but are the present explanations more or less that

1. 7% is better than what the FDA came up with.
   
2. BSWP is to blame.

I acknowledge that regulators possess knowledge beyond what ordinary people do. They see many more publications and are faced with creative thinking during sc. advices and their internal meetings. That counts for something. Still it would be good with transparency here. If EMA wants transparency re. clinical study data, forcing companies to reveal their data, then can't we hope the WP's will follow suit? It could benefit so many if they did and they would get rid of so much complaining, if the science they put into the guideline development is proper (and mind you, I do not thereby mean to insinuate anything).
Consider the requirement about as a mandatory term for stage in two-stage trials. Why? For the known methods at the time this guideline was published there was no known (published) design for which that requirement made any difference. One might think the regulators would perhaps have reviewed some designs and found them useful and where the requirement would have made sense. We'll never know. We can only watch and be gobsmacked that they in that case never made the designs visible to us.

I am not in this game to hurt someone's feelings. At the end of the day I just hope the patient's risk is being controlled. It just doesn't appear to be controlled for the present regulatory version of scaling, so I naturally hope it will be fixed. Likewise I am not asking for anyone to stand up and admit a mistake was made, I am just asking for it to be fixed.
Compare to individual BE and parametric population BE, two concepts that were also extremely interesting from a theoretical perspective and which mercifully were put in the bottom drawer as knowledge grew. This wasn't someone's mistake, the concepts were abandoned because they turned out not to be too useful for the purposes they were invested for even though the basic thinking was right. At the end noone was to blame. And perhaps the time has now come to take a fresh view on things. Fresh, I wrote. The fuel that drives regulatory evolution is science and -I hope- not personal pride or hurt feelings.

I wish you all a good day.