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

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 ≤ δ_{L} or Ft-Fr ≤ δ_{U}

Ha: δ_{L} < Ft-Fr < δ_{U}

Usage

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

Arguments

alpha	significance level
beta	power = 1- beta
sigma1.1	σ_{a.b} with a=1 and b=1.
delta	delta is the bioequivalence limit. here delta=0.223
epsilon	epsilon=Ft-Fr

Value

σ_{a.b}^{2}=σ_{D}^{2}+a*σ_{WT}^{2}+b*σ_{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
# 21

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