题　目：Model-based Bioequivalence Test in 2x2 Crossover Design 主讲人：陈玉英教授（中央大学统计所） 时　间：101年4月27日(星期五)上午10:40-11:30 地　点：交大综合一馆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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