Dadgar D, Burnett P E
Analytical Department, Phoenix International Life Sciences, Montreal, Quebec, Canada.
J Pharm Biomed Anal. 1995 Dec;14(1-2):23-31. doi: 10.1016/0731-7085(95)01634-1.
Evaluation of selectivity is one of the most controversial aspects of method validation and application of methods to studies. The focus of selectivity testing should address the question: Above what level will interference significantly impact on study conclusions? Four key issues will be addressed: the statistical relevance of any selectivity test performed; a criterion for significant interference; experimental methods to establish selectivity; and criteria for acceptance. To ensure that compound integrity is maintained throughout the work-up process, statistically meaningful methods of stability evaluation which are associated with specific acceptance criteria are required. Suitable methods for evaluating stability of analyte and/or solutions of analyte, in process stability, processed sample stability, long term stability and freeze-thaw stability, as well as meaningful acceptance criteria, are presented.
选择性评估是方法验证以及方法在研究中应用最具争议的方面之一。选择性测试的重点应解决以下问题：干扰在何种水平之上会对研究结论产生重大影响？将讨论四个关键问题：所进行的任何选择性测试的统计学相关性；显著干扰的标准；确立选择性的实验方法；以及验收标准。为确保在整个后处理过程中化合物的完整性，需要与特定验收标准相关联的具有统计学意义的稳定性评估方法。本文介绍了评估分析物和/或分析物溶液在过程稳定性、处理后样品稳定性、长期稳定性和冻融稳定性方面稳定性的合适方法，以及有意义的验收标准。
