題 目：Model-based Bioequivalence Test in 2x2 Crossover Design
主講人：陳玉英教授（中央大學統計所）
時 間：101年4月27日(星期五)上午10:40-11:30
地 點：交大綜合一館427室
Abstract
In a pharmacokinetic (PK) study under a 2x2 crossover design, two sequences
of subjects are administered with test (T) and reference (R) drugs in two
different periods. One sequence of subjects takes drugs R and then T, and
the other receives drugs T and then R. The drug concentrations of each
subject are then repeatedly measured over a certain time points after drug
administration which is referred to as the drug concentration-time profile.
The procedure currently used for testing the bioequivalence (BE) between the
two drugs in such a setting is a non-compartmental analysis (FDA USA, 2003).
To provide an alternative BE test, we introduce a non-linear mixed effect
model for the drug concentration-time profiles. In the statistical model, we
consider a one-compartment PK model along with between-subject variation and
the joint distribution of the repeatedly measured drug concentrations from
the same subject is a multivariate generalized gamma distribution. We then
develop a BE test based on the difference between the areas under the two
drug concentration-time curves that are estimated from the statistical model.
We further present some results of a simulation study investigation of the
level and power performances of the model-based BE test and other competitive
tests. Finally, we demonstrate the use of the model-based BE test by using a
data set involving drugs for reducing uric acid in blood. This is joint work
with Chi-Shen Huang of National Central University.
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