Bioequivalence and Bioavailability Forum • PROC GLM fixes Subject

PROC GLM fixes Subject [🇷 for BE/BA]

posted by mittyri – Russia, 2016-11-05 11:13 (3523 d 05:48 ago) – Posting: # 16776
Views: 27,698

Hi Kumar,

❝ Ok that means sub(seq) is a random effect in proc glm.

Nope! Subject is still fixed, because you are using PROC GLM.
Please see the guide:
Note:PROC GLM uses only the information pertaining to expected mean squares when you specify the TEST option in the RANDOM statement and, even then, only in the extra tests produced by the RANDOM statement. Other features in the GLM procedure—including the results of the LSMEANS and ESTIMATE statements—assume that all effects are fixed, so that all tests and estimability checks for these statements are based on a fixed-effects model, even when you use a RANDOM statement.

❝ But what about above query from WHO.

They just want to see unambiguity in your statement.

❝ Also in EMA que and answer guidance they said all effects should be fixed rather than random (method A). Also as you said there is no meaning of random statement in proc glm. EMA Method also dont have such statement.

Are you working with Replicate study? The things are different there

❝ My confusion is that in the protocol can we write that sub, period, sequence, treatment and sub(seq) will be a fixed effects and seq will be tested against sub(seq) if I am going to use Proc glm.

I think you can provide the SAS code above, so all experts will understand that all effects are still fixed, and the reason of random part there is just an F test.

—
Kind regards,
Mittyri

Complete thread:

R code for analyzing classical 2X2 crossover designed bioequivalence data lizhao 2016-01-22 00:13
- R code for analyzing classical 2X2 crossover designed bioequivalence data ElMaestro 2016-01-22 00:59
  - R code for analyzing classical 2X2 crossover designed bioequivalence data lizhao 2016-01-22 01:26
    - On random effects and bogus statements ElMaestro 2016-01-22 12:13
      - FDA 'own' SAS code for 2x2 d_labes 2016-01-27 09:57
        
        FDA 'own' SAS code for 2x2 nobody 2016-01-27 10:09
        
        OT: PM to ElMaestro Helmut 2016-01-27 13:39
        On coffee and such... ElMaestro 2016-01-27 13:47
      - Geometric means ± SD Helmut 2016-01-27 13:51
        
        Geometric means ± SD nobody 2016-01-27 15:20
        
        Money makes the world go ’round Helmut 2016-01-27 16:11
        
        Money makes the world go ’round nobody 2016-01-27 16:31
        
        Fixed or random effect kumarnaidu 2016-11-04 14:05
        
        PROC GLM fixes Subject mittyri 2016-11-04 23:00
        
        PROC GLM fixes Subject kumarnaidu 2016-11-05 05:22
        
        PROC GLM fixes Subjectmittyri 2016-11-05 10:13
        
        PROC GLM fixes Subject kumarnaidu 2016-11-07 06:24
        
        PROC GLM fixes Subject mittyri 2016-11-07 11:57
        
        PROC GLM fixes Subject kumarnaidu 2016-11-07 12:42
        
        Geometric means ± SD Ben 2016-11-08 21:20
        
        Misunderstanding Helmut 2016-11-09 15:29
        
        Misunderstanding Ben 2016-11-14 19:40
        
        RTFM Helmut 2016-11-14 21:50