Mantel-Haenszel统计量在工艺验证中的应用。
An application of the Mantel-Haenszel statistic in process validation.
作者信息
Fairweather William R
机构信息
Flower Valley Consulting, Inc, Rockville, MD 20853, USA.
出版信息
J Biopharm Stat. 2005;15(2):253-64. doi: 10.1081/bip-200048828.
PMID:15796293
Abstract
Discrepancies in the data of a bioequivalence study led to questions about the procedures used in the analytical laboratory. In this article we describe some statistical and graphical procedures that were used to explore the causes of a process failure for an unvalidated process.
摘要
一项生物等效性研究的数据差异引发了对分析实验室所采用程序的质疑。在本文中，我们描述了一些统计和图形程序，这些程序用于探究一个未经验证的过程出现故障的原因。
Zotero 插件