Bioequivalence and Bioavailability Forum

❝ ❝ ... we considered various TSDs (“type 2”: ).

❝

❝ From that I assume that you aimed for an European submission.

❝ But then I wonder: Type 2 aka Potvin C? No longer regulatory caveats expected for this?

❝ Sorry, I can't reproduce your numbers. Could you please write down the power.2stage.fC() call?

power.2stage.fC(alpha=rep(0.0313, 2), n1=46, CV=0.3, GMR=0.95,
  targetpower=0.8, fCrit="PE", fClower=0.825, theta0=0.95,
  npct=c(0.05, 0.25, 0.5, 0.75, 0.95))
Method Bf: alpha (s1/s2)= 0.0313 0.0313
Interim power monitoring step included.
Target power in power monitoring and sample size est. = 0.8
BE margins = 0.8 ... 1.25
CV = 0.3; n(stage 1) = 46; GMR = 0.95
GMR = 0.95 and mse of stage 1 in sample size est. used.
Futility criterion for PE = outside 0.825 ... 1.212121

1e+05 sims at theta0= 0.95 (p(BE)='power').
p(BE)    = 0.85284
p(BE) s1 = 0.80877
Studies in stage 2 = 10.1%

Distribution of n(total)
- mean (range) = 47 (46 ... 96)
- percentiles
 5% 25% 50% 75% 95%
 46  46  46  46  54