Bioequivalence and Bioavailability Forum

Hi all,

Question. In a 3-way partial replicate study, how do you handle subjects in terms of statistics?

1. who completed test treatment arm and only 1 reference treatment arm
   
2. who completed only the 2 replicate reference treatment arms

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?

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

Thanks
John

---

Edit: Category changed. [Helmut]