Non-parametric N [Power / Sample Size]

posted by Helmut Homepage – Vienna, Austria, 2022-09-06 19:02 (88 d 20:10 ago) – Posting: # 23274
Views: 720

Hi Alex,

❝ So we would calculate our N based on a non-parametric test for T-max differences (I have heard some epidemologists saying its ok to calculate with T-Test and increase like 15%)


That’s black magick. Why 15%?

❝ Kind of related, I guess no concern exists about the almost sure increase in Cmax if it doesnt go beyond the therapeutic range inst it?


No idea. In the EMA’s bracketing approach you perform a Non-Superiority test with an upper margin of 1.25. All of this stuff (including BE) is not related to the therapeutic range at all.

❝ Not possible to calculate N for Tmax but to perform certain simulations with some parameters.


Even then it’s not an easy job.

❝ So better to run a pilot without and seein what comes?


Yes.

❝ if you are right Tmax will come sooner (with a higher Cmax).


Likely. But as I wrote before: Under the premise of no saturable pre-systemic metabolism.

❝ Would it support a SmPC change?


No idea. Once you have the result of a pilot, consider a scientific advice. Sweden?

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