Bioequivalence and Bioavailability Forum

Dear Andrew!

❝ The authority concerned is Belgium.

Oops!

❝ Perhaps they have a statistician who gets excited about this sort of thing!

Perhaps the assessor is a physician understanding statistical terms “of one or two syllables only”. Maybe he didn’t bother reading the GL and had still the 2008’s draft on his desk (lines 512–7):

[…] tests for difference and the respective confidence intervals for the treatment effect, the period effect, and the sequence effect should be reported for descriptive assessment. A test for carry-over should not be performed and no decisions regarding the analysis (e.g. analysis of the first period, only) should be made on the basis of such a test. The potential for carry-over can be directly addressed by examination of the pre-treatment plasma concentrations in period 2 (and beyond if applicable).

Based on stakeholder's comments (pp.141–3) suggested tests were removed and are not required according to the current GL.

Reading ElMaestro’s post I went back to the original question. I overlooked that the assessor asked for the subject effect. This is ridiculous. If you don’t have a significant subject effect maybe you have set BMI-limits to 21.25–21.75 kg/m², have included quadruplets+, or even clones in the study…

Statistics – A subject which most statisticians find difficult
but in which nearly all physicians are expert. Stephen Senn