FDA's HVD SAS Code from Progesterone Guidance [RSABE / ABEL]

posted by jag009  – NJ, 2013-04-22 14:39 (2985 d 07:15 ago) – Posting: # 10458
Views: 21,780

Hi everyone,

I am getting some strange results using the FDA Progesterone Scaled Average Bioequivalence SAS Code → The portion to compute the Unscaled Average 90% C.I.

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;


Should the Test/Reference Ratio from the Scaled Average BE computation be similar (if not the same) as the ratio computed from the above Unscaled Average BE code?

Thanks
John


Edit: Category changed. [Helmut]

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