Health Canada ABEL [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2024-07-24 11:06 (52 d 10:50 ago) – Posting: # 24096
Views: 918

Hi John,

❝ What is your CV for AUC? Like Helmut wrote, Canada requires T/R ratio for Cmax, not 90% CI. Therefore you just need to design and power your study based on CV for AUC.

Depends. A more flexible [image]-script is given there. In most cases (esp. if both are highly variable) one even gains power for Cmax.

 design metric method   CV  T/R  n   power
  2x2x4   Cmax     PE 0.43 0.90 12 0.83619
  2x2x4    AUC ABE(L) 0.29 0.95 18 0.81479
Sample size is driven by AUC.
With a sample size of 18 power for Cmax = 0.88712.

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