生物活性测定法替代方法验证研究

Research on the verification of alternative methods of biological activity assay

生物活性测定法是测定成分复杂药品活性的一种生物方法,由于其检测体系复杂,影响因素众多,对其进行理化方法替代研究已成为一种趋势。本文在参考国外药典基础上结合本实验室所做研究,对生物活性测定法的替代研究进行了探讨,并提出了替代方法建立与验证以及一致性研究实验设计和统计分析的一些意见。

Biological activity assay is one kind of method which determines the activity of complex drugs. Because of the numerous influencing factors and complex testing system,the replacement of biological activity assay by physicochemical method has become a trend.Based on the foreign pharmacopoeias and the research of our laboratory,we discuss the replacement of biological activity assay in this article and put forword some proposals about the establishment and verification of alternative methods,the design of consistency experiment and statistical analysis.