Ki F Y, Liu J P, Wang W, Chow S C
Biostatistics and Data Management Department, Bristol-Myers Squibb Company, Plainsboro, New Jersey 08536, USA.
J Biopharm Stat. 1995 Mar;5(1):71-94. doi: 10.1080/10543409508835099.
As a consequence of a hearing on bioequivalence conducted by the Food and Drug Administration in 1986, the identification and the treatment of a potential outlier in bioequivalence trials has become an important issue in the assessment of bioequivalence because the exclusion of a statistically identified outlier may lead to a totally different conclusion on bioequivalence. In this paper, we examine the impact of a statistically identified outlying subject on the decision of bioequivalence through a simulation study under the structure of a standard two-way crossover design based on interval hypotheses for bioequivalence. The Hotelling T2 test suggested by Liu and Weng (1) is used for detection of an outlying subject.
作为美国食品药品监督管理局于1986年举行的一次生物等效性听证会的结果，在生物等效性试验中识别和处理潜在的异常值已成为生物等效性评估中的一个重要问题，因为排除经统计识别出的异常值可能会导致关于生物等效性的完全不同的结论。在本文中，我们通过基于生物等效性区间假设的标准双向交叉设计结构下的模拟研究，检验经统计识别出的异常受试者对生物等效性判定的影响。Liu和Weng（1）建议的霍特林T2检验用于检测异常受试者。
