Bioequivalence and Bioavailability Forum • crap

crap [Two-Stage / GS Designs]

posted by d_labes – Berlin, Germany, 2020-02-16 19:34 2001:16b8:5cfa:9f00:34b8:564b:455e:bee6 – Posting: # 21175
Views: 1,673

Dear Helmut,

» ...
» Name Method Type GMR power alpha TIE ANVISA comp delta
» SLF B 1 0.90 0.8 0.0272 0.04997 0.04999 higher 2E-5
» SLF B 1 0.90 0.9 0.0268 0.04985 0.04977 lower 8E-5
» Potvin B 1 0.95 0.8 0.0294 0.04876 0.04879 higher 3E-5
» Potvin-SLF B 1 0.95 0.8 0.0302 0.04999 0.05020 higher 2E-4
» Fuglsang B 1 0.95 0.9 0.0284 0.04960 0.04958 lower 2E-5
» Fuglsang-SLF B 1 0.95 0.9 0.0286 0.04999 0.05032 higher 3E-4
» Montague D 2 0.90 0.8 0.0280 0.05180 0.05181 higher 1E-5
» Montague-SLF D 2 0.90 0.8 0.0268 0.04998 0.04980 lower 2E-4
» Fuglsang C/D 2 0.90 0.9 0.0269 0.05021 0.05011 lower 1E-4
» Fuglsang-SLF C/D 2 0.90 0.9 0.0266 0.04995 0.04967 lower 3E-4
» Potvin C 2 0.95 0.8 0.0294 0.05143 0.05136 lower 7E-5
» Potvin-SLF C 2 0.95 0.8 0.0282 0.05010 0.05010 equal
» Fuglsang C/D 2 0.95 0.9 0.0274 0.05010 0.05010 equal
» Fuglsang-SLF C/D 2 0.95 0.9 0.0275 0.04962 0.04985 higher 2E-4
»
» TIE which is significantly >0.05 in red (limit of the binomial test 0.05036). I don’t understand why in some scenarios the TIE is lower with a minimum n₂.
» Counterintuitive. :confused:

I'm quite sure: This is because of the simulation error. The differences of the TIE without and with min.n2 are so small. See the last column above.
Any try with a different seed of the random number generator may and will change the comparison.

Edit: Removed irrelevant columns for clarity. [Helmut]

—
Regards,

Detlew

Complete thread:

ANVISA guidelines for two-stage design Mauricio Sampaio 2020-02-11 20:52 [Two-Stage / GS Designs]
- Brainless copy-and-paste-devil Helmut 2020-02-12 02:26
  - Brainless copy-and-paste-devil Mauricio Sampaio 2020-02-12 17:33
- ANVISA guidelines for two-stage design ElMaestro 2020-02-12 08:27
  - ANVISA guidelines for two-stage design nobody 2020-02-12 08:49
  - ANVISA guidelines for two-stage design Helmut 2020-02-12 13:12
  - ANVISA guidelines for two-stage design Mauricio Sampaio 2020-02-12 17:04
  - ANVISA guidelines for two-stage design Mauricio Sampaio 2020-02-12 17:11
- ANVISA guidelines for two-stage design ElMaestro 2020-02-12 21:54
  - crap Helmut 2020-02-15 17:53
    - crap Mauricio Sampaio 2020-02-16 05:01
      - crap Helmut 2020-02-16 15:43
        
        crapd_labes 2020-02-16 19:34
        
        Explained crap remains crap Helmut 2020-02-17 12:49
        
        Proposed changes Mauricio Sampaio 2020-02-17 13:50
        
        Proposed changes Helmut 2020-02-17 14:16