Bioequivalence and Bioavailability Forum

Although not specifically addressed **cough**, I would add to the discussion some old-school knowledge on validation:

Method validation in the bioanalytical laboratory. Buick AR, Doig MV, Jeal SC, Land GS, McDowall RD. J Pharm Biomed Anal. 1990;8(8-12):629-37.


Shah VP, Midha KK, Dighe S, et al. Analytical method validation: bioavailability, bioequivalence, and pharmacokinetic studies. J Pharm Sci. 1992;81:309–312.


What is determined by the methodology described would be "Vergleichspräzision" in Tschörman. It's an old tradition and describes some kind of precision on more than one day/one calibration. There are gazillions of ways to determine variabilities, including/excluding error propagation.
In the end of the day it's only kind of convention how to do it.

Usual way: Problem -> solution. If no problem, don't look for solution