Bioequivalence and Bioavailability Forum • PROC GLM fixes Subject

PROC GLM fixes Subject [🇷 for BE/BA]

posted by kumarnaidu – Mumbai, India, 2016-11-07 07:24 (3520 d 10:13 ago) – Posting: # 16783
Views: 27,611

Dear Mittyri and all,

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

Its a 2x2 crossover study.

❝ 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.

proc glm data=replicate;
class formulation subject period sequence;
model logDATA= sequence subject (sequence) period formulation;
estimate "test-ref" formulation -1+1;
test h=sequence e=subject(sequence);
lsmeans formulation / adjust=t pdiff=control("R") CL alpha=0.10;
run;

This is Method A from EMA Q&A guidance. Ideally in GLM all effects are fixed.
Can we call here sub(seq) as a fixed effect?

—
Kumar Naidu

Complete thread:

R code for analyzing classical 2X2 crossover designed bioequivalence data lizhao 2016-01-22 00:13 [🇷 for BE/BA]
- 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 Subject mittyri 2016-11-05 10:13
        
        PROC GLM fixes Subjectkumarnaidu 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