Bioequivalence and Bioavailability Forum

Hi everyone,

Question regarding the ABE SAS code from FDA's progesterone guidance when SCABE is not applicable due to within subject SD being < 0.294 (Yes I am back with this. Helmut feel free to link this message to the previous one I posted a few days ago). For a three way partial replicate study (Test, Reference x2)

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=SUJ;
ESTIMATE 'T vs. R' TRT 1 -1/CL ALPHA=0.1;
ods output Estimates=unsc1;
title1 'unscaled BE 90% CI - guidance version';
title2 'AUCt';
run; data unsc1;
set unsc1;
unscabe_lower=exp(lower);
unscabe_upper=exp(upper);
run;

Proc Mixed output two residuals, a reference and test. Which one does SAS use to compute the 90%CI? My guess is the test? (Yes Helmut, I read your slides but I have doubts snice this is a test vs Refx2 Partial Rep study).

Example:

Covariance Parameter Estimates
Cov Parm  Subjec   Group             Estimate
FA(1,1)   subject                    1.2543
FA(2,1)   subject                    1.3108
FA(2,2)   subject                    0.4234
Residual  subject  formulation Ref   0.3115
Residual  subject  formulation Test  0.3192

T/R Ratio (%)  Lower 90% CI  Upper 90% CI
89.9586        74.5097       108.611

Thanks
John