IUT [Power / Sample Size]

posted by Helmut Homepage – Vienna, Austria, 2023-09-19 16:04 (269 d 02:52 ago) – Posting: # 23721
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Hi xpresso & welcome to the club!

I think that you are overdoing it.
If you have multiple PK metrics and all must pass (that’s the regulatory requirement) at level \(\small{\alpha}\) – in general 0.05 – you are protected against inflation of the type I error by the intersection-union principle.1 No need for simulations,2 simply calculate power for given T/R-ratio, CV, and the sample size. If any of the metrics shows power <50%, the study will fail (see this article).


  1. Berger RL, Hsu JC. Bioequivalence Trials, Intersection-Union Tests and Equivalence Confidence Sets. Stat Sci. 1996; 11(4): 283–302. JSTOR:2246021.
  2. Zeng A. The TOST confidence intervals and the coverage probabilities with R simulation. March 14, 2014. Online.

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