基于容忍区间法评估个体生物等效性时的样本量考量
Sample size considerations for assessing individual bioequivalence based on the method of tolerance intervals.
作者信息
Esinhart J D, Chinchilli V M
机构信息
Medical Data Sciences Department, Glaxo Inc., Research Triangle Park, North Carolina 27709.
出版信息
Int J Clin Pharmacol Ther. 1994 Jan;32(1):26-32.
PMID:8199749
Abstract
This is the consideration of sample sizes for assessing individual bioequivalence based on the use of tolerance intervals. The sample size procedures discussed include a direct distribution-free method, indirect parametric method and a direct parametric method. Design considerations are discussed based on the results of the direct parametric method. Tables are provided for easy access of results.
摘要
这是基于容忍区间使用来评估个体生物等效性的样本量考量。所讨论的样本量计算方法包括一种直接非参数方法、间接参数方法和一种直接参数方法。基于直接参数方法的结果讨论了设计考量。还提供了表格以便于获取结果。
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