Bioequivalence and Bioavailability Forum • Group effects FDA/EMA

Group effects FDA/EMA [Two-Stage / GS Designs]

posted by mittyri – Russia, 2014-08-21 17:34 (3862 d 07:11 ago) – Posting: # 13416
Views: 43,104

Dear Helmut,

❝ Group = not a reasonable effect?

As I understand correct, no one can answer on this question...
I've read some topics about group effect in the statistical model, by the way I still have some questions
1. Is it obligatory EMA's requirement to use Group effect in the model in all cases when there is more than one group? Any experience of LoDs due to absence of Group effect in the statistical model?

2. What kind of statistical model is preffered for Europe submission?
According to the Detlew's post

❝ In context of a 2-Stage design, also a 2-group design with groups here called stage, the mighty oracle prohibit us the Group-by-Treatment Interaction! From the EMA Q&A Rev.7 :

❝ "Conclusion ... A term for a formulation*stage interaction should not be fitted."

ElMaestro wrotes that

❝ Although I think the formulation x group interaction would steal a df and would be tested against the model residual (within). You are right that any step towards increasing the model residual translates into producer's risk.

Did you ever use the model without group × treatment?
Something like that:
Fixed: sequence, period, treatment, group, subject(sequence)

3. Did you ever got the requests from EMA experts about calculating the CI into one of the groups as for FDA submision?

Sorry for probable repeating some questions

Edit: I’m off for a three weeks vacation. I’m sure others will have a lot to say in the meantime. ;-)

[Helmut]

—
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/EMAmittyri 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 term mittyri 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