Bioequivalence and Bioavailability Forum • Fixed effects model with Group term

Fixed effects model with Group term [Two-Stage / GS Designs]

posted by mittyri – Russia, 2016-10-09 15:27 (2749 d 04:13 ago) – Posting: # 16708
Views: 35,357

Dear All,

Now I'm using the model from 2-stage design (without Period term):

    muddle <- lm(log(Var)~Group+Seq+Seq*Group+Subj%in%(Seq*Group)+Per%in%Group+Trt, data=data) 

    # like in 2 stage design; 

    # I know that Subject %in% ... is just a Subject, I didn't change this term for consistency

BTW the question is still there, because the output is the same as above (PE and MSE are different)
Also please note that the Group factor is extremely significant
When I run this dataset for FDA Model I in Phoenix (don't know the code for R):


  Dependent Hypothesis Numer_DF Denom_DF        F_stat     P_value

1   Ln(Var)        int        1       14 3.1047428e+03 0.000000000

2   Ln(Var)      Group        1       14 9.9615453e-01 0.335181899

3   Ln(Var)        Seq        1       14 9.7094813e-01 0.341167964

4   Ln(Var)  Group*Seq        1       14 5.7364354e-02 0.814182229

5   Ln(Var)  Group*Per        2       14 3.2110481e+00 0.071153125

6   Ln(Var)        Trt        1       14 3.4404496e+00 0.084798088

7   Ln(Var)  Trt*Group        1       14 2.3942317e-01 0.632200219

The Group factor is faraway from significant level.

It could be a nightmare for Russia, where the experts insist on the Group term in the model, but all other things should be like in EMA Guideline with all factors as fixed (does someone realize how many studies will be failed? The experts suggest not to pool the groups in this case like the FDA Guidance states!)

—
Kind regards,
Mittyri

Complete thread:

Potvin C in the EU Helmut 2013-04-16 17:40 [Two-Stage / GS Designs]
- Potvin C in the EU ElMaestro 2013-04-17 02:31
  - Potvin C in the EU Helmut 2013-04-17 12:23
    - 2 Groups model FDA d_labes 2013-04-17 13:10
      - 2 Groups model FDA Helmut 2013-04-17 16:37
        
        Group effects obsolete? d_labes 2013-04-18 09:55
        
        Group effects FDA/EMA Helmut 2013-04-19 14:34
        
        Group effects FDA/EMA mittyri 2014-08-21 15:34
        
        Group effects FDA/EMA ElMaestro 2014-08-21 17:31
        
        Group effects EMA mittyri 2014-10-01 11:25
        
        Group effects EMA ElMaestro 2014-10-01 11:31
        Group effects EMA Helmut 2014-10-01 13:24
        
        Group effects EMA VStus 2016-10-06 22:06
        
        Group effects EMA ElMaestro 2016-10-07 12:45
        
        Group effects EMA mittyri 2016-10-07 15:06
        
        Fixed effects model with Group termmittyri 2016-10-09 13:27
        
        Fixed effects model: changing the F, p values mittyri 2016-10-10 18:33
        
        Fixed effects model: changing the F, p values ElMaestro 2016-10-10 20:10
        
        Fixed effects model: changing the F, p values Helmut 2016-10-11 00:17
        Holy War of type III d_labes 2016-10-11 13:17
        
        Significance of Group effect in Russia: why the type III is so 'important' mittyri 2016-10-11 15:07
        
        Fixed effects model: changing the F, p values zizou 2016-10-11 01:06
        
        FDA group model in R mittyri 2016-10-11 13:43
        
        FDA group model in R ElMaestro 2016-10-12 01:07
        FDA group model in R VStus 2016-10-17 15:32
        
        FDA group model in R ElMaestro 2016-10-17 18:58
        
        FDA group model in R VStus 2016-10-20 13:57
        
        Fixed effects model with Group term VStus 2016-10-20 13:54
        
        Group effects FDA/EMA zizou 2016-12-31 02:54
        
        Group effects FDA/EMA Helmut 2017-06-03 14:57
        
        2 Groups model FDA hiren379 2013-08-22 14:32
        
        Homework Helmut 2013-08-23 11:53