Bioequivalence and Bioavailability Forum

Study conduct in groups [Design Issues]

posted by Smitha – India, 2015-02-02 05:21 (4164 d 05:24 ago) – Posting: # 14344
Views: 32,015

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?

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 
  • 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