Bioequivalence and Bioavailability Forum • 2 Groups model FDA

2 Groups model FDA [Two-Stage / GS Designs]

posted by hiren379 – India, 2013-08-22 14:32 – Posting: # 11336
Views: 32,486

Hi HS

» Followed by:
» If the Group-by-treatment interaction test is not statistically significant (p ≥0.1), only the Group-by-treatment term can be dropped from the model.
» … provided that the group meets minimum requirements for a complete bioequivalence study.

According to the above statement, what should be the minimum requirements of the group for a complete bioequivalence study?

Complete thread:

Potvin C in the EU Helmut 2013-04-16 17:40
- 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 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 FDAhiren379 2013-08-22 14:32
        
        Homework Helmut 2013-08-23 11:53