Bioequivalence and Bioavailability Forum

Hi all,

I have a simple question about analyzing two treatments from a >2 arms study, as per ICH M13a recommendation below:

"...The analysis for each comparison should be conducted excluding the data from the treatments that are not relevant to the comparison in question”

I have a 4-treatment 4-sequence BA study (ABCD) and I want to carry out a comparison C vs D. How should I prepare the PK parameter dataset?
1) Should I just leave the pk parameters as blank (missing) for treatment A and B and then run proc mix?
2) or I should remove treatment A and B data from the dataset so that it only contains C and D data before running proc mix?

I also got an advice from a stat fellow who told me to convert the study into a 2-way 2-sequence study before running proc mixed(????). What he meant was remove treatment A and B data and also convert the 4 sequences - ABDC, BCAD, CDBA, DACB, by removing the A + B and leave only C + D so to end up with 2 sequences CD and DC.

Thx
J