Bioequivalence and Bioavailability Forum • FDA RSABE & alpha inflation

FDA RSABE & alpha inflation [RSABE / ABEL]

posted by d_labes – Berlin, Germany, 2015-02-03 14:07 (3753 d 10:12 ago) – Posting: # 14362
Views: 22,574

Dear Helmut

❝ I used

❝ power.RSABE(CV=0.30, n=24, theta0=0.8,


                design="2x3x3", nsims=1e6)

❝ [1] 0.116132

❝

❝ I don’t see the inflation vanishing. On the contrary:

❝ power.RSABE(CV=se2CV(0.30), n=24, theta0=0.8,


                design="2x3x3", nsims=1e6)

❝ [1] 0.126651

That's the knackpunkt: They force us not to look at theta0=0.8 or 1.25 but if s_W>0.25 at exp(+-sW*ln(1.25)/0.25) i.e. at 0.7694922 | 1.299558 if CV=30%. See Fig. 2 and the paragraph "Controversies" of that paper.

And then hokus pokus:

power.RSABE(CV=0.30, n=24, theta0=1.299558, design="2x3x3", nsims=1e6)

[1] 0.048717

—
Regards,

Detlew

Complete thread:

EMA oracle Helmut 2015-01-27 16:27 [RSABE / ABEL]
- EMA oracle nobody 2015-01-27 17:07
- Personal opinion ElMaestro 2015-01-27 17:56
- EMA oracle d_labes 2015-01-27 19:44
  - EMA oracle nobody 2015-01-28 09:04
    - EMA oracle ElMaestro 2015-01-28 13:11
- Response from Alfredo García-Arieta Helmut 2015-01-30 10:55
  - Response from Alfredo García-Arieta nobody 2015-01-30 14:55
    - Wonnemann’s Figure 4 on steroids Helmut 2015-02-01 01:35
      - Wonnemann’s Figure 4 on steroids nobody 2015-02-01 11:18
        
        Wonnemann’s Figure 4 on steroids Helmut 2015-02-01 14:49
      - General remarks ElMaestro 2015-02-01 18:43
        
        General remarks nobody 2015-02-01 22:04
        General remarks Helmut 2015-02-02 00:48
        
        General remarks nobody 2015-02-02 08:09
        
        General remarks Helmut 2015-02-02 14:06
        
        TIE: questions mittyri 2015-02-03 12:44
        
        TIE: questions Helmut 2015-02-03 13:24
        
        FDA RSABE & alpha inflation d_labes 2015-02-03 12:02
        
        FDA RSABE & alpha inflation Helmut 2015-02-03 12:22
        
        FDA RSABE & alpha inflationd_labes 2015-02-03 13:07
        
        FDA RSABE & alpha inflation Helmut 2015-02-03 13:41
- New Zealand nobody 2015-01-31 11:25
  - New Zealand Helmut 2015-02-01 16:08
    - New Zealand nobody 2015-02-01 22:08
      - New Zealand Helmut 2015-02-01 23:54
        
        New Zealand nobody 2015-02-02 08:07