Bioequivalence and Bioavailability Forum

Dear All,

Need help on formula/procedure to find out the Intersubject Variability for a Full replicate design using SAS.

Based on the Program given in the progesterone guideline below:

PROC MIXED
 data=pk;
 CLASSES SEQ SUBJ PER TRT;
 MODEL LAUCT = SEQ PER TRT/ DDFM=SATTERTH;
 RANDOM TRT/TYPE=FA0(2) SUB=SUBJ G;
 REPEATED/GRP=TRT SUB=SUBJ;
 ESTIMATE 'T vs. R' TRT 1 -1/CL ALPHA=0.1;
 ods output Estimates=unsc1;
 title1 'unscaled BE 90% CI - guidance version';
 title2 'AUCt';

As there is no subj(seq) in the random statement, I am not able to calculate the inter-subject variabilities for test and reference treatments. Please help me with this calculation.

But when I use the proc varcomp procedure in SAS, I am able to generate the Variabilities (Inter and Intra) for test and reference treatments. My doubt is that whether it is acceptable by FDA regulatory?

Thanks in Advance,