Bioequivalence and Bioavailability Forum

Hi Lucas,

❝ I found, yesterday, this Public Assessment Report from EMA where the Wilcoxon Signed Rank Test was used (Pages 13 and 14), but seems like no CI was assessed as FDA requests. I'm not really sure on how to construct a 95% CI for MSt-1.25*MSr (where MSt= Mean Score for test and MSr= Mean Score for reference).

The guideline can be read in two ways. Easiest and perhaps compliant is to construct a 95% CI for MSt and compare it with the border 1.25MSr.

❝ You mean classify the scores as meaningful (i.e. 2 or higher) and not meaningful (i.e. 1 or lower)?

I thought meaningful non-adhesion was 1 or higher.

❝ I think that the Wilcoxon SR test, as it was used in the Actavis study linked above, would be a good way do compare T vs R, since it also evaluates (indirectly) the adhesion through time. What do you think?

Sounds ok to me, if it is ok to regulators too is of course the million dollar question. Or perhaps we should speak of reals in this case

I just looked at the PAR you referred to: How on earth is table 11.4.8 to be interpreted? Can you help?