Bioequivalence and Bioavailability Forum • R code for analyzing classical 2X2 crossover designed bioequivalence data

R code for analyzing classical 2X2 crossover designed bioequivalence data [🇷 for BE/BA]

posted by lizhao – US, 2016-01-22 02:26 (3439 d 12:17 ago) – Posting: # 15843
Views: 26,844

Hi ElMaestro,

Thank you very much for your help. I do have a question about using lm() instead of lme() function in R. Based on my understanding, subject effect should be considered to be random effect :confused:

? If I use lm(), all effects are treated as fixed effects. You suggest me to use lm, is it based on FDA or EMA guidance?

Another question would be related to plot mean curves of Test and Reference product. If I want to plot a mean plot (mean and error bars) of a crossover biequivalence study, should I use within-subject confidence intervals or between-subject confidence intervals? They are apparently quite different.

Thanks again!

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 datalizhao 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 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