Bioequivalence and Bioavailability Forum

Hi Qwerty!

❝ In the most recent EMEA guideline it asks for the "tests for difference and the respective confidence intervals for the treatment effect, the period effect, and the sequence effect should be reported as descriptive data."

No it doesn’t. You are referring to the draft GL (p.13, lines 512–514), back in 2008 when EMA was still called EMEA.

❝ What exactly does this mean?

Gibberish; except the CI of the treatment effect – that’s how we assess BE, right?

❝ How are they calculated? Can a SAS code be used to calculate the CIs on these effects.

If you are able to code SAS for BE (the CI of the treatment effect), ask politely for the CI of the others. But: The period effect does not influence the treatment effect anyway (means out), and the sequence effect (or unequal carry-over) cannot be handled properly in a 2×2 cross-over (confounded with treatment-by-period interaction). Therefore: forget it.

❝ I'm slightly confused as I thought that the confidence intervals for the difference in means between the two products to show bioequivalence would be the same as the CI for the treatment effect.

Right.