IBE: Individual Bioequivalence

In TrialSize: R Functions for Chapter 3,4,6,7,9,10,11,12,14,15 of Sample Size Calculation in Clinical Research

Description

Consider 2 by 2 crossover design. γ=δ^2+σ_D^2+σ_{WT}^2-σ_{WR}^2-θ_{IBE}*max(σ_{0}^2,σ_{WR}^2)

Ho: γ ≥ 0

Ha: γ < 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

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 

TrialSize documentation built on July 8, 2020, 7:19 p.m.