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RegisterNon-parametric N [Power / Sample Size]
Dear Helmut thanks for answering
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]
❝ 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:
- N calculation for trial about PK superiority alejandro_jo1990 2022-09-01 14:40 [Power / Sample Size]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Bracketing approach Helmut 2022-09-01 15:02
- SmPC change is the whole thing alejandro_jo1990 2022-09-01 16:18
- N calculation for trial about PK superiority dshah 2022-09-02 11:52
- The efocus is faster absorption alejandro_jo1990 2022-09-02 18:57
- The efocus is faster absorption Helmut 2022-09-03 00:46
- Non-parametric Nalejandro_jo1990 2022-09-06 00:26
- Non-parametric N Helmut 2022-09-06 17:02
- Non-parametric N alejandro_jo1990 2022-09-15 14:56
- Non-parametric N Helmut 2022-09-06 17:02
- Non-parametric Nalejandro_jo1990 2022-09-06 00:26
- The efocus is faster absorption Helmut 2022-09-03 00:46
- The efocus is faster absorption alejandro_jo1990 2022-09-02 18:57
- Bracketing approach Helmut 2022-09-01 15:02
Ing. Helmut Schütz