Replicate Designs & IntraSubj CV [General Sta­tis­tics]

posted by randombadger – UK, 2011-04-28 15:02 (5528 d 03:46 ago) – Posting: # 6963
Views: 15,678

Hello all,

I have a 3 period, 2 treatment XO design and would like to calculate the intra-subject CV for the two treatments.

According to FDA guidance, I should use the following SAS code:
PROC MIXED DATA= cmax ;
  CLASSES armcd usubjid period treat ;
  MODEL LOG_PARM = armcd period treat / DDFM=KR;
  RANDOM treat/TYPE=FA0(2) SUB=usubjid G;
  REPEATED/GRP=treat SUB=usubjid;
  ESTIMATE 'B vs A' treat -1 1/CL ALPHA=0.1;
  LSMEANS treat/ cl alpha=0.1;
RUN;


however I see my colleagues are using the following:
PROC MIXED DATA= cmax ;
   CLASS USUBJID period treat ARMCD ;
   MODEL LOG_PARM = treat period ARMCD  /ddfm=KR; 
   RANDOM USUBJID(ARMCD) ;
   REPEATED/GRP=treat SUB=usubjid ;
   ESTIMATE "B vs A"  TREAT  -1 1 /cl alpha=0.1;
   LSMEANS treat/ cl alpha=0.1;
RUN;


and I am finding the intra-subject CV's are quite different. I am a little confused regarding which RANDOM statement to use. Can anyone explain the differences and which statement is best to use?

My colleagues also included a carryover in the model but I believe the washout periods are long enough hence not required.

Thanks,
RB

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