Bioequivalence and Bioavailability Forum

Dear ElMaestro,

very interesting!

❝ So my questions: Are these data correct - could some one with more

❝ specialised software check those values?

I have not recalculated your values, but I have the very strong feeling they are correct. What your data show: The higher your N the higher the chance of failing the danish BE criterion if the variability is low enough.

This is reasonable to me because with higher N the confidence interval gets tighter (as Martin has already stated) and therefore the 1.0 is not contained in the CI if your point estimate of the BE ratio is distinct enough from 1.0.

❝ Did anyone ever understand the Danish thinking?

No, never.
They have changed the usually accepted BE test from
"The BE ratio (population) is allowed to vary between 0.80 and 1.25"
by act of law to the test
"The ratio (population) must be not distinct from 1.0".

This results in your "strange" power numbers.

Suppose the BE metric varies only to a very low extent (zero as a limit, but then we statisticians become unemployed ), then you will always conclude "No bioequivalence" in the danish thinking, provided your BE ratio is below or above 1.0.

IMHO this is not the correct answer to the Bioequivalence question.

But let me restate: "How unsearchable are Regulator's judgments and how inscrutable Regulator's ways! Amen." (Romans 11:33, 36)