Bioequivalence and Bioavailability Forum

FDA RSABE & alpha inflation [RSABE / ABEL]

posted by Helmut  – Vienna, Austria, 2015-02-03 13:22 (3753 d 07:18 ago) – Posting: # 14360
Views: 22,653

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


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