Bioequivalence and Bioavailability Forum • Proc GLM rulez

Proc GLM rulez [Software]

posted by Helmut – Vienna, Austria, 2014-02-03 17:16 (4156 d 13:37 ago) – Posting: # 12325
Views: 28,225

Dear Detlew,

❝ ❝ ... 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.

Correct. Fingers faster than brain. In the obsolete (July 1992) guidance “Statistical Procedures for Bioequivalence Studies using a Standard Two-Treatment Crossover Design” FDA recommended that

An analysis of variance (ANOVA) should be performed […] using General Linear Models (GLM) procedures of SAS or an equivalent program.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Complete thread:

How to calculate intersubject variability in PHX WinNonlin zan 2014-01-29 23:58 [Software]
- 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 rulezHelmut 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