TrialSize (version 1.4)

ISV.NIS: Test for Non-Inferiority/Superiority of Intra-Subject Variabilities

Description

the ratio = within-subject variance of treatment T / within-subject variance of treatment R

H0: the ratio \(\ge \delta\)

Ha: the ratio < \(\delta\)

if \(\delta\) < 1, the rejection of Null Hypothesis indicates the superiority of the test drug over the reference for the intra-subject variability;

if \(\delta\) > 1, the rejection of the null hypothesis implies the non-inferiority of the test drug against the reference for the intra-subject variability; .

Usage

ISV.NIS(alpha, beta, sigma1, sigma2, m, margin)

Arguments

alpha

significance level

beta

power = 1-beta

sigma1

within-subject variance of treatment 1

sigma2

within-subject variance of treatment 2

m

for each subject, there are m replicates.

margin

margin=delta, the true ratio of sigma1/sigma2

References

Chow SC, Shao J, Wang H. Sample Size Calculation in Clinical Research. New York: Marcel Dekker, 2003

Examples

# NOT RUN {
Example.9.1.1<-ISV.NIS(0.05,0.2,0.3^2,0.45^2,3,1.1)
Example.9.1.1
# }