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RegisterN calculation for trial about PK superiority [Power / Sample Size]
Hello to all! first thanks for this wonderful forum, here a young MD, clinical pharmacologist recently moving from clinical trials conduct to design, tryinto apply my (modest) knowledge of clinical PK and biostatistics to phase I trial design. I was discussing with a former colleague. If we were to design a trial to try to support a change in SmPC for a certain product, ie. a faster absorption:
- If we were to demostrate in overall a faster absorption, we would need to design a superiority trial and calculate N based on expected diff in logCmax using logsd (difference or more conservative the higer Cmax maybe?). Suggested log to use a diff in means to calculate N and Cmax as is the parameter to include both extentand and rate of absorption (I deem Tmax as useless).
-If we were to demonstrate a faster absorption at X point (10 minutes), before Tmax, shall I need to use the differences in logAUC with same SD assessment? or concentration at 10 minutes would suffice (or maybe any approach is not correct at all).
I assume I would calculate N based on the difference in means as in any study.
PS. I swear I conducted an intensive research through the forum
BR
Alex
- If we were to demostrate in overall a faster absorption, we would need to design a superiority trial and calculate N based on expected diff in logCmax using logsd (difference or more conservative the higer Cmax maybe?). Suggested log to use a diff in means to calculate N and Cmax as is the parameter to include both extentand and rate of absorption (I deem Tmax as useless).
-If we were to demonstrate a faster absorption at X point (10 minutes), before Tmax, shall I need to use the differences in logAUC with same SD assessment? or concentration at 10 minutes would suffice (or maybe any approach is not correct at all).
I assume I would calculate N based on the difference in means as in any study.
PS. I swear I conducted an intensive research through the forum
BR
Alex
Complete thread:
- N calculation for trial about PK superiorityalejandro_jo1990 2022-09-01 14:40
![[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 N alejandro_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 N alejandro_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