Non-parametric N [Power / Sample Size]

posted by alejandro_jo1990 – Spain, 2022-09-06 02:26 (449 d 18:30 ago) – Posting: # 23271
Views: 1,727

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]

Complete thread:

UA Flag
Activity
 Admin contact
22,811 posts in 4,783 threads, 1,639 registered users;
21 visitors (0 registered, 21 guests [including 10 identified bots]).
Forum time: 19:56 CET (Europe/Vienna)

Every man gets a narrower and narrower field of knowledge
in which he must be an expert in order to compete with other people.
The specialist knows more and more about less and less
and finally knows everything about nothing.    Konrad Lorenz

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5