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RegisterNon-inferiority Sample Size Estimation [Power / Sample Size]
Hii All...
Anyone know about the sample size estimation for the non inferiority clinical trials, as per the literatures and some google says to consider the NI Margin to some percentage and estimate the sample size
I have tried to do the same in FARTSSIE23 (Non-inferiority, Parallel), but in addition to that Standard deviation is necessary for the same and in SAS (PROC POWER), we need to provide the CV to estimate the sample size
Can we assume the standard deviation or we need to provide the exact Standard deviation (obtained from the literatures on the drug) ?
Dose the same criteria applicable as that of the ISCV concept for the bio equivalence studies?
Best Regards...
Edit: Category changed; see also this post #1. [Helmut]
Anyone know about the sample size estimation for the non inferiority clinical trials, as per the literatures and some google says to consider the NI Margin to some percentage and estimate the sample size
I have tried to do the same in FARTSSIE23 (Non-inferiority, Parallel), but in addition to that Standard deviation is necessary for the same and in SAS (PROC POWER), we need to provide the CV to estimate the sample size
Can we assume the standard deviation or we need to provide the exact Standard deviation (obtained from the literatures on the drug) ?
Dose the same criteria applicable as that of the ISCV concept for the bio equivalence studies?
Best Regards...
Edit: Category changed; see also this post #1. [Helmut]
Complete thread:
- Non-inferiority Sample Size Estimationsury 2019-04-16 08:44
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Non-inferiority Sample Size Estimation Helmut 2019-04-16 16:53
- Non-inferiority Sample Size Estimation sury 2019-04-17 06:55
- Read, read, read! Helmut 2019-04-17 10:59
- Non-inferiority Sample Size Estimation sury 2019-04-17 06:55
- Non-inferiority Sample Size Estimation Helmut 2019-04-16 16:53
Ing. Helmut Schütz