Bioequivalence and Bioavailability Forum

Output of sampleN.scABEL() - expanded limits ? [Power / Sample Size]

posted by d_labes  – Berlin, Germany, 2022-03-23 17:33 (758 d 06:07 ago) – Posting: # 22865
Views: 2,516

Dear Helmut,

❝ 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)


❝ Switching CVwR     : 0.3


❝ Regulatory constant: 0.76


❝ Expanded limits    : 0.7706 ... 1.2977


❝ Upper scaling cap  : CVwR > 0.5


❝ PE constraints     : 0.8000 ... 1.2500

...

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

Complete thread:

• Sample size and Replicated studies Bebac user 2022-03-23 09:38 
  • Sample size and Replicated studies dshah 2022-03-23 11:30
    • Output of sampleN.scABEL() Helmut 2022-03-23 12:43
      • Output of sampleN.scABEL() - expanded limits ?d_labes 2022-03-23 16:33
        • Output of sampleN.scABEL() - expanded limits ? Helmut 2022-03-23 16:45
      • Output of sampleN.scABEL() dshah 2022-03-23 18:08
        • Don’t use FARTSSIE for SABE Helmut 2022-03-23 19:42
  • Sample size larger than clinical capacity Helmut 2022-03-23 11:43
  • Sample size and Replicated studies Brus 2022-03-23 14:25