Bioequivalence and Bioavailability Forum • Study conduct in groups

Study conduct in groups [Design Issues]

posted by Smitha – India, 2015-02-02 05:21 (3737 d 11:16 ago) – Posting: # 14344
Views: 28,464

Dear all,
If a Bioequivalence study has to be conducted in 2 groups (say 20 volunteers each), does the FDA or EMA require that all 40 volunteers be recruited into the study before Group 1 Period 1 dosing? :confused:

If yes, pls provide also the relevant reference/s

Would appreciate responses to this query.

Thanks and regards,
Smitha

Complete thread:

Study conduct in groupsSmitha 2015-02-02 04:21 [Design Issues]
- Study conduct in groups ElMaestro 2015-02-02 08:21
- Study conduct in groups Helmut 2015-02-02 13:08
  - Study conduct in groups Smitha 2015-02-04 04:30
    - Study conduct in groups Helmut 2015-02-04 12:57
      - Study conduct in groups felipeberlinski 2015-02-04 22:36
        
        Study conduct in groups ElMaestro 2015-02-04 23:58
        Significant ≠ relevant Helmut 2015-02-05 00:49
        
        Significant ≠ relevant Astea 2016-03-24 20:10
        
        Significant ≠ relevant ElMaestro 2016-03-24 23:12
        Significant ≠ relevant zizou 2016-03-25 21:41
        
        Loss of power etc. Helmut 2016-03-26 14:46
        
        Loss of power etc. Astea 2016-03-27 21:18
        Loss of power etc. zizou 2016-03-27 23:44
        
        Combined power? Helmut 2016-03-28 14:29
        Loss of power etc. Astea 2016-03-28 23:57
        
        Loss of power etc. ElMaestro 2016-03-29 00:16
        Mystery Helmut 2016-03-29 17:28
        
        Back to the Future Astea 2016-03-29 21:57
        
        Back to the Future ElMaestro 2016-03-29 23:11
        
        Using lectures != Reading them mittyri 2016-03-30 00:17
        
        Recycling Helmut 2016-03-30 00:42
        
        Recycling Astea 2016-03-30 12:23
        
        Recycling Beholder 2016-03-30 13:00