CrossOver.ISV.NIS {TrialSize}

Test for Non-Inferiority/Superiority of Intra-Subject Variabilitie in Crossover Design

Description

H0: the ratio that within-subject variance of treatment T / within-subject variance of treatment R \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

CrossOver.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

Example.9.1.1<-CrossOver.ISV.NIS(0.05,0.2,0.3^2,0.45^2,2,1.1)
Example.9.1.1