Bioequivalence and Bioavailability Forum

FDA RSABE & alpha inflation [RSABE / ABEL]

posted by Helmut  – Vienna, Austria, 2015-02-03 13:22 (4157 d 17:55 ago) – Posting: # 14360
Views: 26,365

Dear Detlew,

❝ Did you consider the paper

❝ Davit et al. (2012)

❝ in the pictures?

No.

❝ This paper wants us to neglect the discontinuity at CV~30% in looking at the GMR's we assume for bioinequivalence. Instead we are forced to look at widening implied limits from s0=0.25 on (CV~25.4%). Then the inflation at CV=30% hokus pokus vanishes.

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

❝ BTW: Anybody out there to shed some light on the arguments of that paper?

❝ Desired consumer risk model (!), distinct from implementation ...

Not me. I’m as well…

❝ Is it sound or only an attempt to answer discussions about alpha-inflation?

Duno. Talked about the inflation of the TIE with Barbara – but in May 2013.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

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 inflationHelmut 2015-02-03 12:22
                • FDA RSABE & alpha inflation d_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