Deficiencies [Power / Sample Size]
❝ Also you may be correct I must confess that I seldom or never had done this alpha-adjustment in case I used a higher order design. Reasons:
❝ • Never had problems with using un-adjusted alpha in more then 30 years.
I faced two.
- In a dose-linearity study (two adjusted doses compared to one – i.e., not proportionality by the power model). Very similar to the example by Hauschke et al. in chapter 7.4.1 where we find:
“… for a joint decision rule where all requirements must be fulfilled, no adjustment of the comparisonwise type I error is needed to keep the familywise type I error under control.”
Received a deficiency letter from the BfArM in 2005 asking for adjustment:“Aufgrund der multiplen Berechnung (2 Testpräparate) sollte das Bonferroni-adjustierte 95% Konfidenzintervall […] des Referenzproduktes angenommen werden.”
- One of my clients aimed at showing BE of two products (tablet, capsule) vs. the reference. One passed and the other one failed. Only the passing one was submitted. Received a deficiency this year from an undisclosed agency:
“Please provide a statistical analysis with proper alpha-adjustment […] as we are of the opinion, that alpha-adjustment is required for this design.”
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Helmut Schütz
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Science Quotes
Complete thread:
- Sample size for 4-period 4-sequence crossover BE study Bryony Simmons 2018-02-01 12:16 [Power / Sample Size]
- 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
- DeficienciesHelmut 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
- Deficiencies Relaxation 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 22:17
- TIE for NTIDs Helmut 2018-02-05 17:49
- TIE for NTIDs d_labes 2018-02-05 16:40
- 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
- 111.11 for NTIDs Astea 2018-02-05 19:27
- bow TIE for NTIDs d_labes 2018-02-05 22:33
- bow TIE for NTIDs Helmut 2018-02-05 18:10
- bow TIE for NTIDs Astea 2018-02-05 17:52
- TIE for NTIDs Helmut 2018-02-05 01:01
- TIE for NTIDs Astea 2018-02-04 20:04
- TIE for NTIDs d_labes 2018-02-04 12:40
- α and no ω Helmut 2018-02-02 23:39
- alpha... where is omega? Astea 2018-02-02 21:45
- Deficiencies Relaxation 2018-02-02 19:41
- Deficiencies Relaxation 2018-02-02 11:12
- DeficienciesHelmut 2018-02-01 15:48
- Alpha adjustment in higher order crossover d_labes 2018-02-01 14:01
- function sampleN.TOST of package PowerTOST Helmut 2018-02-01 13:01