PBE: Population 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

Consider 2 by 2 crossover design.

H0: lamda >= 0

Ha: lamda < 0

Usage

PBE(alpha, beta, sigma1.1, sigmatt, sigmatr, sigmabt, sigmabr, rho, a, delta, lamda)

Arguments

alpha	significance level
beta	power = 1-beta
sigma1.1	σ_{a.b}^2=σ_{D}^2+aσ_{WT}^2+bσ_{WR}^2. Here a=b=1.
sigmatt	σ_{tt}^2=σ_{BT}^2+σ_{WT}^2, σ_{wt}^2 is the within-subjects variance in test formulation
sigmatr	σ_{tr}^2=σ_{BR}^2+σ_{WR}^2, σ_{wr}^2 is the within-subjects variance in reference formulation
sigmabt	σ_{bt}^2 is the between-subjects variance in test formulation
sigmabr	σ_{br}^2 is the between-subjects variance in reference formulation
rho	rho is the inter-subject correlation coefficient.
a	a= thetaPBE =1.74
delta	delta is the mean difference of AUC
lamda	lamda=delta^{2}+σ^2-σ_{TR}^2-thetaPBE*max(σ_{0}^2,σ_{TR}^2)

References

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

Examples

Example.10.3<-PBE(0.05,0.2,0.2,sqrt(0.17),sqrt(0.17),0.4,0.4,0.75,1.74,0.00,-0.2966)
Example.10.3
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TrialSize documentation built on July 8, 2020, 7:19 p.m.