Bioequivalence and Bioavailability Forum

Hi helmut,

❝ If you are walking the fun road already: You can feed the incomplete data to PROC MIXED and the other way ’round the complete to PHX. You should see again different results, but in reversed order.

Yup, did that all. I love chaos and to confuse my direct reports...

Here is question though but I think I might have asked you (and others) before. With a three way x-over study, what if the 1st formulation fails on 90% CI due to the pool variance being inflated by the 2nd formulation? Can I file something to the agency to have them to re-consider the fact that the 1st formulation actually passes BE if the study was conducted as a two way? How? By collapsing the data into a 2-way study while preserving the order of the T and R treatments are per sequence (i.e., ABC → CB, BAC → AC, CBA → CA etc etc) and run stats? Or remove the 2nd formulation data completely and run stats? So that the width of the 90% CI is attributed to intrasubject CV from both 1st formulation and reference.

Just curious that all. I know I know its a bad thing to do. But I am not altering any data or randomness of the treatments (Am I?).

Thanks
John