test2x2: Bioequivalence test for a variable of a 2x2 study

In BE: Bioequivalence Study Data Analysis

Bioequivalence test for a variable of a 2x2 study

Description

It performs conventional bioequivalence test for 2x2 study. Basic assumption is that the variable is distributed as a log-normal distribution. This is SAS PROC GLM style. If you want PROC MIXED style use nlme::lme.

Usage

test2x2(bedata, Var)

Arguments

bedata	Data table name. This should have at least the following columns and a variable column to be tested. Var column values should be all positive values. GRP : Group or Sequence, 'RT' or 'TR' PRD : Period, 1 or 2 SUBJ : Subject ID TRT : Treatment or Drug, 'R' or 'T'
Var	Variable to be tested. This should be one of the column names in bedata table. Usually 'AUClast' or 'Cmax'

Details

It tests Var variable equivalency from a 2x2 study. Current regulatory requirement is that the 90% confidence interval of geometric mean ratio (Test/Reference) should be within [0.8, 1.25].

Value

Analysis of Variance (log scale)	Analysis of Variance in log scale
Between and Within Subject Variability	Variance in log scale and coefficient of variance in original scale
Least Square Means	Geometric means
90% Confidence Interval	90% confidence interval of geometric mean ratio (T/R)
Sample Size	Sample size for the replication of this study

Author(s)

Kyun-Seop Bae <[e-mail]>

Examples

test2x2(NCAResult4BE, "AUClast")
test2x2(NCAResult4BE, "Cmax")

BE documentation built on Jan. 7, 2023, 1:11 a.m.