生物活性测定方法的适用性评价指标探讨  

Discussion on suitability test measurements for bioassay

作　　者：王萍萍[1] 张媛[1] 谭德讲[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《药物分析杂志》2015年第6期1038-1043,共6页Chinese Journal of Pharmaceutical Analysis

摘　　要：方法的适用性评价是判断一个方法运行是否正常,能否达到其应用需求的重要内容。由于生物活性测定法(生测法)的检测体系复杂,影响因素较多,对其适用性评价的指标探讨较少。本文借鉴化学法系统适用性试验相关理论,探讨生物测定法中的相关内容及其特殊性。其中主要对生测法的系统适用性和样品适用性试验的指标选择、验收标准、评价方法等进行了分析和讨论。通过对比分析发现,生测法方法适用性试验理论体系尚待进一步规范。Suitability test plays an important role in ensuring the performance of the testing system, and ensuring the fitness of a method for its intended use. However, as there are many factors influencing the test in bioassay as well as the complexity of the bioassay, there are few discussions on suitability test for bioassay until now. Thus, in order to address the problem above, this paper elaborated the related contents and specificity of bioassay referring to the relevant theory of suitability test of chemical methods. The paper mainly discussed how to choose the measurements for bioassay and to set up the predetermined acceptance criteria, and investigated the evaluation methods for suitability test. According to the contents discussed above, it was concluded that the theory on suitability test for bioassay remained to be further improved and standardized.

关 键 词：适用性 系统适用性试验 样品适用性试验 方法确认 验收标准 生物活性测定 

分 类 号：R917[医药卫生—药物分析学]