Bioequivalence and Bioavailability Forum

Hi Silva,

❝ […] a CHMP SA on the subject. As I remember from the talk, his opinion was that the agency was also not able to deal with this complex statistical analysis…

EMEA. The European Medicines Evaluation Agency.
The drug regulatory agency of the European Union.
A statistician-free zone.         Stephen Senn (2004)

❝ … and therefore the advice was…

So they felt not to be “able to deal with this complex statistical analysis” and nevertheless gave an advice? Weird.

When you know something, say what you know.
When you don’t know something, say that you don’t know.
That is knowledge.          Confucius

❝ … to consider the second stage group as a group effect and therefore only 90% CI's were calculated and not the 94.12%!

That’s bizarre and a potential serious risk to public health, Imho. Btw, a 94.12% CI (α_adj 0.0294) is not a solution for everything. Some people (including myself) think that already EMA’s standard ABEL inflates the patient’s risk (see this thread). Two stages‽ If somebody does know a pro­cedure, please enlighten me.