Bioequivalence and Bioavailability Forum

❝ We did a full replicate BE study for EU submission a few days back with 40 volunteers.

(why not partial any reason other than power of study??)

❝ The %ISCV observed for reference product was found to be 28% (in pilot it was 43%),

happens dear many times..

Option 1 (logic): As both T1 and T2 are given on same subject, mean on the same subject should be cosidered. this method is logical and correct but may not be favourable in your case.. generally we do in partial replicate when SABE is not applicable..

Ray of hope:
As per my statistician SAS has repeatation of code for replicate design analysed as two way cross over so your 2nd option will be correct..
I hope i helped ...

Chiku:)