Bioequivalence and Bioavailability Forum

Deficiencies [Power / Sample Size]

posted by Relaxation  – Germany, 2018-02-02 20:41 (2273 d 18:54 ago) – Posting: # 18334
Views: 20,520

❝ ❝ But seriously, why should testing alternatives in one study require a punishment and testing in seperate studies not. Because I pay my fee in doubled overhead study costs? Or because I don't have to tell anybody of the "other study" during application ?

❝

❝ IMHO, you have to submit the study’s synopsis.

Hello Helmut.

That was what I thought myself (and would also argue in favour of by gut feeling). But at least in the EU I think we are asked to submit these for the pilot studies conducted with the formulation you apply for. As far as I remember, it is also asked for synopses from other studies during formulation development, but my guess would be that there might be a grey area in the discussion, whether a study conducted with Alternative 1 would be part of the development of Alternative 2.
I personally would argue in favour of "full disclosure", but I generally a lot anyway.

P.S.: I looked it up in the BE-GL: all relevant studies ... comparing the formulation applied for (i.e. same composition and manufacturing process) with a reference medicinal product marketed in the EU.
Would apply to the "tablet vs. reference and capsule vs. reference" example brough up earlier, wouldn't it? Two shots.

Best regards and a nice weekend to everybody,

Relaxation.

Complete thread:

• Sample size for 4-period 4-sequence crossover BE study Bryony Simmons 2018-02-01 12:16 
  • function sampleN.TOST of package PowerTOST Helmut 2018-02-01 13:01
    • Alpha adjustment in higher order crossover d_labes 2018-02-01 14:01
      • Deficiencies Helmut 2018-02-01 15:48
        • Deficiencies nobody 2018-02-01 17:10
        • Deficiencies d_labes 2018-02-01 18:57
          • Deficiencies Relaxation 2018-02-02 11:12
            • Deficiencies nobody 2018-02-02 12:49
            • Deficiencies Helmut 2018-02-02 16:14
              • DeficienciesRelaxation 2018-02-02 19:41
                • alpha... where is omega? Astea 2018-02-02 21:45
                  • α and no ω Helmut 2018-02-02 23:39
                    • TIE for NTIDs d_labes 2018-02-04 12:40
                      • TIE for NTIDs Astea 2018-02-04 20:04
                        • TIE for NTIDs Helmut 2018-02-05 01:01
                          • TIE for NTIDs d_labes 2018-02-05 16:40
                            • TIE for NTIDs Helmut 2018-02-05 17:49
                              • TIE for NTIDs d_labes 2018-02-05 22:17
                                • TIE for NTIDs Helmut 2018-02-06 12:34
                        • TIE for NTIDs d_labes 2018-02-05 16:35
                          • bow TIE for NTIDs Astea 2018-02-05 17:52
                            • bow TIE for NTIDs Helmut 2018-02-05 18:10
                              • 111.11 for NTIDs Astea 2018-02-05 19:27
                                • 111.11 for NTIDs Helmut 2018-02-06 00:12
                            • bow TIE for NTIDs d_labes 2018-02-05 22:33