Vitro.BE {TrialSize}

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

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