[关键词]
[摘要]
供试品的检测与分析是保证药物非临床安全性评价结果可靠性的关键性因素。本文从药物安全性评价中供试品的含量检测方法验证、取样分析、含量准确性分析、稳定性分析、均匀性分析、分析结果和超标准结果的处理、剩余样品的处理等方面进行了讨论,并提出作者的看法。
[Key word]
[Abstract]
The detection and analysis of test samples are key factors to ensure the dependability of nonclinical safety evaluation. This paper comprehensively discussed the practices of analysis on the test samples including method validation for formulation, sample, concentration, stability, homogeneity, interpretation of results, OOS results, and disposition of excess sample.
[中图分类号]
[基金项目]