IUT [Power / Sample Size]

posted by Helmut Homepage – Vienna, Austria, 2023-09-19 16:04 (82 d 20:21 ago) – Posting: # 23721
Views: 844

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.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
 Admin contact
22,823 posts in 4,786 threads, 1,633 registered users;
28 visitors (0 registered, 28 guests [including 5 identified bots]).
Forum time: 11:25 CET (Europe/Vienna)

In these matters the only certainty is
that nothing is certain.    Pliny the Elder

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz