QT.PK.parallel {TrialSize}

Parallel Group Design in QT/QTc Studies with PK response as covariate

Description

Ho: \mu_1 -\mu_2 = 0

Ha: \mu_1 -\mu_2 = d

The test is finding the treatment difference in QT interval. d is not equal to 0, which is the difference of clinically importance.

Usage

QT.PK.parallel(alpha, beta, pho, K, delta, v1, v2, tau1, tau2)

Arguments

alpha

significance level

beta

power = 1-beta

pho

pho=between subject variance \sigma^{2}_{s}/(between subject variance \sigma^2_s+within subject variance \sigma^2_e)

K

There are K recording replicates for each subject.

delta

\sigma^2=\sigma^2_s+\sigma^2_e. d is the difference of clinically importance. \delta = d/\sigma

v1

sample mean for group 1

v2

sample mean for group 2

tau1

sample variance for group 1

tau2

sample variance for group 2

References

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

Examples

Example.15.1.4.1<-QT.PK.parallel(0.05,0.2,0.8,3,0.5,1,1,4,5)
Example.15.1.4.1
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