Bioequivalence and Bioavailability Forum

Dear All!

Just found a paper of two well-knowns:

Scott D. Patterson, Byron Jones
"Viewpoint: observations on scaled average bioequivalence"
Pharmaceutical Statistics
Volume 11, Issue 1, pages 1–7, January/February 2012

Online resource here.

Just to cite their end statement:
"In conclusion, many caveats apply to the statistical methods being used and/or proposed for SABE, and caveat emptor likely applies to products approved using these approaches. If application of SABE proceeds (and based upon the findings of this paper, this is not recommended), an obvious need for international harmonisation presents itself."
(Colour emphasis by me.)

Wow ! Cough !