Non-parametric N [Power / Sample Size]

posted by alejandro_jo1990 – Spain, 2022-09-06 02:26 (681 d 01:25 ago) – Posting: # 23271
Views: 2,519

Dear Helmut thanks for answering

❝ Instead of equivalence you are interested in a one-sided test.


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%)
I swear its thing that would have come to my mind was using Tmax.
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?


Edit 2022-09-06 15:56:
I apologize and reply myself/give a maybe more accurate answer after reading again the article. Not possible to calculate N for Tmax but to perform certain simulations with some parameters. So better to run a pilot without and seein what comes? if you are right Tmax will come sooner (with a higher Cmax). Would it support a SmPC change?


Edit: Merged with a later (now deleted) post. You can edit your posts for 24 hours. [Helmut]

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