test2x2: 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)
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
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'
Author
Kyun-Seop Bae <k@acr.kr>
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].