Bioequivalence and Bioavailability Forum

Dear Helmut!

Sorry for wasting your time on such a question, I was totally confused by that letter.

❝ You posted in the category Regulatives / Guidelines. What do you mean by “planning regulatory documents”?

I meant Eurasian economical commission, but there are no information about missing data in that document. The above statement about data replacement was made during one of the seminars deducated to the acception of the new rules.

❝ That’s bizarre.

I totally agree that it is impossible to use it in BE studies. Just wanted to get the link on the documentation where it should be stated that it is incorrect. Suppose it was somebody's invention...

❝ BTW, the EMA’s GL wants only complete subjects (T and R) in simple crossovers and at least one period with each of T and R in replicate designs. Both the EMA’s and the FDA’s SAS-code for reference-scaling drop incomplete subjects.

That's what I do. Just to get sure I interpreted correctly..