Bioequivalence and Bioavailability Forum

Hi John,

good points!

❝ For #2, I spoke with one CRO and they said they do not include those subjects in the overall BE statistics (SABE or BE). However, they said the subjects data will be included in determining the withinsubject standard deviation (variation). I think we should not include those subjects at all or their data should be included in all stats if they are included in the determination of witinsubject variaton. Suggestion?

Including subjects with only RR data would probably give a more precise estimate of CV_WR. However, personally I would not include them (see below).

❝ For #1, subject should be kept for all statistics. Agree?

I can only speak from the European perspective.

Ideally, all treated subjects should be included in the statistical analysis. However, subjects in a crossover trial who do not provide evaluable data for both of the test and reference products […] should not be included.