Bioequivalence and Bioavailability Forum • PROC GLM fixes Subject

PROC GLM fixes Subject [🇷 for BE/BA]

posted by kumarnaidu – Mumbai, India, 2016-11-07 13:42 (3057 d 16:38 ago) – Posting: # 16785
Views: 23,504

Thanks Mittyri,

❝ yes, you can.

❝ I kindly suggest to review the statistical part of the protocol with statistician experienced in BEQ studies evaluation. It would be useful for you, for this study and for the product.

The confusion arises due to the difference in the opinion :-D

. Some CRO stat experts says all effects in the above program are fixed and some says that sub(seq) cannot be a fixed because we are test seq against this. Also the EMA guidance says that all effects are fixed in the Method A (PROC GLM).

—
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 Subject kumarnaidu 2016-11-07 06:24
        
        PROC GLM fixes Subject mittyri 2016-11-07 11:57
        
        PROC GLM fixes Subjectkumarnaidu 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