ABE: Average Bioequivalence

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

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

Example.10.2<-ABE(0.05,0.2,0.4,0.223,0.05)
Example.10.2
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TrialSize documentation built on April 12, 2025, 2:01 a.m.