Bioequivalence and Bioavailability Forum • FDA code for non-replicate crossover?

FDA code for non-replicate crossover? [Software]

posted by d_labes – Berlin, Germany, 2014-02-03 16:54 (4096 d 06:21 ago) – Posting: # 12324
Views: 27,788

Dear Helmut,

❝ ... But – hey! – that’s not the code given in FDA’s guidances. ;-)

where does your opinion came from?
So far as I know there is no code given in the FDA's guidances for non-replicate cross-over studies.

Moreover on page 10 of the 2001 Statistical guidance they recommend Proc GLM:
"General linear model procedures available in PROC GLM in SAS or equivalent software are preferred, although linear mixed-effects model procedures can also be indicated for analysis of nonreplicated crossover studies.

For example, for a conventional two-treatment, two-period, two-sequence (2 x 2) randomized crossover design, the statistical model typically includes factors accounting for the following sources of variation: sequence, subjects nested in sequences, period, and treatment. The Estimate statement in SAS PROC GLM, or equivalent statement in other software, should be used to obtain estimates for the adjusted differences between treatment means and the standard error associated with these differences."

—
Regards,

Detlew

Complete thread:

How to calculate intersubject variability in PHX WinNonlin zan 2014-01-29 23:58
- Negative variance component Helmut 2014-01-30 01:16
  - Negative variance component zan 2014-01-30 18:11
  - Negative variance component zan 2014-01-31 00:16
    - Negative variance component ElMaestro 2014-01-31 08:20
    - Negative variance component yjlee168 2014-01-31 10:26
      - Example data set Helmut 2014-02-01 16:03
        
        Example data set yjlee168 2014-02-01 17:40
        
        PHX build 6.3.0.395 / 6.4.0.511 Helmut 2014-02-02 02:04
        
        PHX build 6.3.0.395 / 6.4.0.511 yjlee168 2014-02-02 07:54
    - Negative variance component ElMaestro 2014-02-01 16:31
      - Negative variance component yjlee168 2014-02-01 17:47
        
        Just thinking loud ElMaestro 2014-02-01 19:02
        
        All models are wrong… Helmut 2014-02-02 02:31
        
        another book for linear model yjlee168 2014-02-02 08:07
      - References Helmut 2014-02-02 02:19
        
        References ElMaestro 2014-02-02 09:56
    - Negative variance component – Chow/Liu d_labes 2014-02-03 09:02
      - Negative variance component – Chow/Liu ElMaestro 2014-02-03 10:22
        
        Variance components – Proc mixed d_labes 2014-02-03 11:58
        
        Variance components – Proc mixed ElMaestro 2014-02-03 12:58
        
        Variance components – Proc mixed 90% CIs d_labes 2014-02-03 13:16
        Variance components – Proc mixed Helmut 2014-02-03 14:14
        
        FDA code for non-replicate crossover?d_labes 2014-02-03 15:54
        
        Proc GLM rulez Helmut 2014-02-03 16:16
        
        Variance components – Proc mixed yjlee168 2014-02-03 20:43
        
        NOBOUND Helmut 2014-02-03 22:08
      - lm() or lme() for 2x2x2 study design? yjlee168 2014-02-03 20:22
        
        lm() or lme() for 2x2x2 study design? ElMaestro 2014-02-03 22:11
        
        lm() or lme() for 2x2x2 study design? yjlee168 2014-02-04 13:09
        
        bear for 2x2x2 study with negative variance components yjlee168 2014-02-05 19:12