Bioequivalence and Bioavailability Forum

Dear Detlew,

❝ ❝ In coding the function sampleN.scABEL.ad() I tried to be more specific (see also my post below) and it gives for \(\small{CV_\textrm{wT}=CV_\textrm{wR}=0.3532}\):

Regulatory settings: EMA (ABEL)


❝ ❝ Expanded limits    : 0.7706 ... 1.2977


❝ ❝ Upper scaling cap  : CVwR > 0.5

...

❝ The Expanded limits are only valid if the CV's are exactly the assumed ones.

❝ They don't play any role during the simulations because the expansion applied depends on the CVwR of actual study, gradually different from study to study of the simulation.

Of course, you are right.

❝ That was the reason why the ugly programmer of the function sampleN.scABEL() abstain from giving that numbers .

Don’t know which one of us is uglier. Beauty lies in the eye of the beholder. When it comes to coding, I’m notorious for producing ‘Spaghetti viennese’. I decided to give the expanded limits because in the simulations of the empiric Type I Error theta0 is set to the upper one.