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

posted by d_labes  – Berlin, Germany, 2008-02-06 14:34 (6143 d 07:36 ago) – Posting: # 1590
Views: 15,157

Hallo LS,

❝ 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


Only SAS knows (The power to know) :-D .

This is an example of the silly and somewhat counter-intuitive syntax of PROC MIXED. The key is the /Sub=subj part in the random statement.
This defines a random subject effect within each TRT, i.e. the random subject effects are assumed different for treatment groups in the study. So you can have different variabilities for test and reference products.

If you need some deeper and more elaborate text about models and evaluation of replicate cross-over designs have a look at

Scott D Patterson and Byron Jones
REPLICATE DESIGNS AND AVERAGE, INDIVIDUAL, AND
POPULATION BIOEQUIVALENCE

GSK BDS Technical Report 2002 – 01

Can be found in the net of nets
http://biometrics.com/wp-content/uploads/2009/06/tr2002-01.pdf

--
Edit: Updated URL. [Helmut]

Regards,

Detlew

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