Bioequivalence and Bioavailability Forum • Food not the same between groups

Food not the same between groups [BE/BA News]

posted by ElMaestro – Denmark, 2021-11-17 10:50 (1027 d 22:18 ago) – Posting: # 22672
Views: 5,414

Hi beholder,

❝ Many times the approach with resigning from testing group effect based on justification in protocol that volunteers undergoes the same procedures, take the same batch of drug etc., was fine and very helpful for many protocols. But. Recently one clinic has used two slightly different types of menu for two groups. Volunteers ate the same food in period 1 and 2. Could this situation lead to necessity to test group effect since not the same procedures were implemented to two groups or this difference has too little weight?

It could easily lead to a significiant group effect. Whether you need to test for that is up to the assessor. If you don't they'll probably ask for it. If you do, they'll probably tell you it was unnecessary (but behind the curtains they have checked the p-value).

—
Pass or fail!
ElMaestro

Complete thread:

EMA BE-GL: Clarifications / Corrections? Helmut 2010-06-22 18:53 [BE/BA News]
- Good news!? d_labes 2010-06-23 10:09
  - Good news!? Helmut 2010-06-23 10:11
    - Update Helmut 2011-02-05 18:48
      - Q&A published 14 March 2011 Helmut 2011-03-16 13:44
        
        Q&A published 14 March 2011 ElMaestro 2011-03-16 14:20
        Phoenix/WinNonlin 6.1.0.173 Helmut 2011-03-17 04:23
        ANOVA party prevails d_labes 2011-03-17 11:00
        
        THX! Helmut 2011-03-19 02:59
        
        Outlier d_labes 2011-03-24 11:55
        
        Outliers - yes, but how? Helmut 2011-03-24 15:09
        
        Questions and Ambiguities d_labes 2011-03-28 14:16
        Residuals and Outliers in Replicate Design Crossover Studies d_labes 2011-04-04 08:53
        
        Info requested ElMag 2011-03-24 12:45
        
        Confused as well... Helmut 2011-03-24 16:50
        
        Q&A published 14 March 2011 Priyanka_S 2011-03-21 14:28
        
        SAS code: Warning d_labes 2011-03-21 16:08
        
        Copy & paste Helmut 2011-03-21 22:38
        
        Subtleties, flaws, questions d_labes 2011-03-22 09:24
        
        Subtleties, flaws, questions Helmut 2011-03-27 20:35
        
        Not estimable in the model The user 2017-03-14 10:16
        
        Not estimable in the model ElMaestro 2017-03-14 11:02
        
        Not estimable in the model The user 2017-03-14 12:13
        
        Not estimable in the model ElMaestro 2017-03-14 12:41
        
        Not estimable in the model Helmut 2017-03-18 21:59
        
        Food not the same between groups Beholder 2021-11-10 14:35
        
        Food not the same between groupsElMaestro 2021-11-17 09:50