TrialSize (version 1.4)

IBE: Individual Bioequivalence

Description

Consider 2 by 2 crossover design. \( \gamma=\delta^2+\sigma_D^2+\sigma_{WT}^2-\sigma_{WR}^2-\theta_{IBE}*max(\sigma_{0}^2,\sigma_{WR}^2)\)

Ho: \(\gamma \ge 0 \)

Ha: \(\gamma < 0 \)

Usage

IBE(alpha, beta, delta, sigmaD, sigmaWT, sigmaWR, a, b, thetaIBE)

Arguments

alpha

significance level

beta

power = 1-beta

delta

delta is the mean difference

sigmaD

sigmaD^2=sigmaBT^2+sigmaBR^2-2*rho*sigmaBT*sigmaBR, sigmaBT^2 is the between-subjects variance in test formulation, sigmaBR^2 is the between-subjects variance in reference formulation

sigmaWT

sigmaWT^2 is the within-subjects variance in test formulation

sigmaWR

sigmaWR^2 is the within-subjects variance in reference formulation

a

Sigma(a,b)=sigmaD^2+a*sigmaWT^2+b*sigmaWR^2

a=0.5 here

b

b=0.5 here

thetaIBE

thetaIBE=2.5

References

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

Examples

# NOT RUN {
Example.10.4<-IBE(0.05, 0.2, 0, 0.2,0.3,0.3,0.5,0.5,2.5)
Example.10.4

# n=22 IBE reach 0 
# }