Bioequivalence and Bioavailability Forum

Results [General Statistics]

posted by randombadger – UK, 2011-05-03 14:03 (5121 d 09:12 ago) – Posting: # 6982
Views: 11,184

Dear all,

Thank you for your responses so far, they have been very supportive. Please see below for results from my analyses:

Model 1

PROC MIXED DATA= cmax ; 

   CLASS USUBJID period treat ARMCD ; 

   MODEL LOG_PARM = treat period ARMCD  /ddfm=KR;  

   RANDOM USUBJID(ARMCD) /G;

   REPEATED/GRP=treat SUB=usubjid ;

   ESTIMATE "B vs A"  TREAT  -1 1 /cl alpha=0.1; 

   LSMEANS treat/ cl alpha=0.1;

RUN;



Estimated G Matrix



                                                Planned

                        Unique Subject          Arm

   Row  Effect          Identifier              Code    Col1     Col2



     1  USUBJID(ARMCD)  XXX XXX-X-XXX-00011001  ABB     0.07056      

     2  USUBJID(ARMCD)  XXX XXX-X-XXX-00011003  ABB             0.07056

(block diagonal, apologies for the lack of formatting)
etc

Intra-Subject

CV A (%)    CV B (%)

 31.98       10.02

Model 2

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;





Estimated G Matrix

                 Unique Subject

Row    Effect    Identifier            TREAT    Col1     Col2



1    TREAT     XXX XXX-X-XXX-00011001    A     0.1036   0.05780

2    TREAT     XXX XXX-X-XXX-00011001    B     0.05780  0.07110

Intra-Subject

CV A (%)    CV B (%)

 22.88        9.78

As you can see, the differences in CV's are quite large hence my concern on the most appropriate code to apply. Note: the treatments were nowhere near bioequivalent.

Edit: Formatted. You may use BBCodes (see here). [Helmut]

Complete thread:

Replicate Designs & IntraSubj CV randombadger 2011-04-28 13:02 [General Statistics]
- Replicate Designs & IntraSubj CV Helmut 2011-04-28 15:00
  - Replicate Designs & IntraSubj CV randombadger 2011-04-28 15:25
    - Replicate Designs & IntraSubj CV Helmut 2011-04-28 17:09
    - Inter-subject dance with the wolves d_labes 2011-04-29 11:33
      - How many subjects? jdetlor 2011-05-02 18:21
        
        G matrix d_labes 2011-05-03 08:26
        
        G matrix ElMaestro 2011-05-03 09:15
        
        G matrix d_labes 2011-05-03 09:51
        
        Resultsrandombadger 2011-05-03 12:03
        
        Results - comments d_labes 2011-05-03 14:32
        
        Results - comments randombadger 2011-05-03 16:53
        
        Lost cents d_labes 2011-05-04 08:07
        
        G matrix ElMaestro 2011-05-03 14:16
        
        G matrix jdetlor 2011-05-03 19:37

Results [General Sta­tis­tics]

Complete thread:

Results [General Statistics]