Bioequivalence and Bioavailability Forum • FDA's HVD SAS Code from Progesterone Guidance

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

posted by jag009 – NJ, 2013-04-22 18:39 (4379 d 22:32 ago) – Posting: # 10458
Views: 29,732

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]

Complete thread:

FDA's HVD SAS Code from Progesterone Guidancejag009 2013-04-22 16:39 [RSABE / ABEL]
- Proc MIXED vs. Proc GLM Helmut 2013-04-22 17:47
  - Proc MIXED vs. Proc GLM jag009 2013-04-22 20:33
    - SAS vs. PHX Helmut 2013-04-22 22:10
      - SAS vs. PHX Shuanghe 2013-04-23 11:45
        
        SAS vs. SAS d_labes 2013-04-23 16:50
        
        SAS vs. SAS vs. Phoenix Helmut 2019-11-12 13:01
      - SAS vs. PHX jag009 2013-04-23 15:56
        
        SAS Warning (Note) on Proc Mixed jag009 2013-04-23 17:07
        
        Nut Job.. jag009 2013-04-30 21:09
        
        Second opinion (PHX 6.3) Helmut 2013-05-01 16:21
        
        Second opinion (PHX 6.3) jag009 2013-05-01 17:16
        
        Second opinion (PHX 6.3) ElMaestro 2013-05-01 18:48
        In praise of a full replicate Helmut 2013-05-01 19:16
        Third opinion d_labes 2013-05-02 12:00
        
        Compound Symmetry Helmut 2013-05-02 14:41
        
        Compound Symmetry - SASian (1) d_labes 2013-05-02 16:26
        
        Variance=0 Helmut 2013-05-03 16:07