TrialSize (version 1.4)

Vitro.BE: In Vitro Bioequivalence

Description

Consider 2 by 2 crossover design. \(\zeta = \delta^2+sT^2+sR^2-thetaBE*max(\sigma_0^2,sR^2)\) . \(sT^2=\sigma_{BT}^2+\sigma_{WT}^2\), \(sR^2=\sigma_{BR}^2+\sigma_{WR}^2\)

Ho: \(\zeta \ge 0 \)

Ha: \(\zeta < 0 \)

Usage

Vitro.BE(alpha, beta, delta, sigmaBT, sigmaBR, sigmaWT, sigmaWR, thetaBE)

Arguments

alpha

significance level

beta

power = 1-beta

delta

delta is the mean difference

sigmaBT

\(\sigma_{BT}^2\) is the between-subjects variance in test formulation

sigmaBR

\(\sigma_{BR}^2\) is the between-subjects variance in reference formulation

sigmaWT

\(\sigma_{WT}^2\) is the within-subjects variance in test formulation

sigmaWR

\(\sigma_{WR}^2\) is the within-subjects variance in reference formulation

thetaBE

here thetaBE=1

References

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

Examples

# NOT RUN {
Example.10.5<-Vitro.BE(0.05,0.2,0,0.5,0.5,0.5,0.5,1)
Example.10.5

# n=43 Vitro.BE reach 0

# }