TrialSize (version 1.4)

ABE: Average Bioequivalence

Description

The most commonly used design for ABE is a standard two-sequence and two-period crossover design. Ft is the fixed effect of the test formulation and Fr is the fixed effect of the reference formulation.

Ho: Ft-Fr \( \le \delta_{L} \) or Ft-Fr \( \le \delta_{U} \)

Ha: \( \delta_{L} \) < Ft-Fr < \( \delta_{U} \)

Usage

ABE(alpha, beta, sigma1.1, delta, epsilon)

Arguments

alpha

significance level

beta

power = 1- beta

sigma1.1

\(\sigma_{a.b}\) with a=1 and b=1.

delta

delta is the bioequivalence limit. here delta=0.223

epsilon

epsilon=Ft-Fr

Value

$$ \sigma_{a.b}^{2}=\sigma_{D}^{2}+a*\sigma_{WT}^{2}+b*\sigma_{WR}^{2}$$.

References

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

Examples

# NOT RUN {
Example.10.2<-ABE(0.05,0.2,0.4,0.223,0.05)
Example.10.2
# 21

# }