Bioequivalence and Bioavailability Forum • random effect, fix effect in the guidance Appendix E

random effect, fix effect in the guidance Appendix E [Regulatives / Guidelines]

posted by LS – 2008-02-05 19:53 (6271 d 09:21 ago) – Posting: # 1589
Views: 19,887

Hi,
For average BE analysis of replicated crossover studies, the following SAS code is from Guidance for Industry 'Statistical Approaches to Establishing Bioequivalence', January 2001, Appendix E

PROC MIXED;
CLASSES SEQ SUBJ PER TRT;
MODEL Y=SEQ PER TRT/DDFM=SATTERTH;
RANDOM TRT/TYPE=FA0(2) SUB=SUBJ G;
REPEATED/GRP=TRT SUB=SUBJ;
ESTIMATE 'T vs. R' TRT 1-1/CL ALPHA=0.1;

Does anybody know which why TRT is written in random effect and also in fixed effect. Why TRT is random effect? What description is correct to address statistical method from the above code

Thanks

LS

Complete thread:

random effect, fix effect in the guidance Appendix ELS 2008-02-05 18:53 [Regulatives / Guidelines]
- random effect, fix effect in the guidance Appendix E d_labes 2008-02-06 13:34
  - random effect, fix effect in the guidance Appendix E LS 2008-02-06 17:58
    - random effect, fix effect in the guidance Appendix E d_labes 2008-02-07 10:14
      - random effect, fix effect in the guidance Appendix E SKR 2008-03-06 10:54
        
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        Satterthwaite degrees of freedom d_labes 2008-03-10 09:59
        
        Satterthwaite DF; SAS Helmut 2008-03-10 12:24
        
        Satterthwaite DF; SAS d_labes 2008-03-10 14:50
        
        Satterthwaite DF; SAS mathews 2008-03-11 07:12
        
        SAS Proc Mixed coding, replicate design d_labes 2008-03-11 09:43
        
        SAS Proc Mixed coding, replicate design Sathya 2008-09-17 07:21
        
        Replicate design evaluation d_labes 2008-09-17 10:49
        
        Replicate design evaluation Sathya 2008-09-18 06:43