建立和验证药物安全性评价中实验病理学定量检测指标参考值范围的影响因素和方法  

Influencing factors and methods in establishment and verification of reference intervals of quantitative assays of experimental pathology in drug safety evaluation

作　　者：王晓秋 江佳佳[2] WANG Xiao-qiu;JIANG Jia-jia(Suzhou Xishan Zhongke Pharmaceutical Research and Development Co.,Ltd.,Suzhou 215104,China;Aoyang Institute of Cancer,Jiangsu University,Suzhou 215600,China)

机构地区：[1]苏州西山中科药物研究开发有限公司,江苏苏州215104 [2]江苏大学澳洋肿瘤研究院,江苏苏州215600

出　　处：《中国药理学与毒理学杂志》2022年第9期716-720,共5页Chinese Journal of Pharmacology and Toxicology

摘　　要：目前国内外药物安全性评价领域尚未见到明确的有关实验动物病理学定量检测指标参考值范围和验证指导原则。本文探索性地提出了建立和验证药物安全性评价中实验病理学定量检测指标参考值范围的影响因素和方法,认为建立参考值范围所需评估条件应包括前瞻性或回顾性研究方式的选择、动物参考群体分组、动物参考个体筛选和数量及样品采集和检测要求等;当动物参考群体来源、样本采集条件和检测系统发生改变时参考值范围则需进行验证,并应根据参考值范围从统计学、生物学和毒理学意义等方面深入解析检测数据的应用。本文将有助于正确和完整地评价实验动物的健康状态和药物引起的毒性。As far as drug safety evaluation is concerned,there are no specific guidelines for the establishment and verification of reference intervals for quantitative assays of experimental pathology of laboratory animals.This article affempts to present influencing factors and methods for the establishment and verification of reference intervals for laboratory animals.Assessment of the establishment of reference intervals involves selection of prospective or retrospective approaches,grouping of animal reference populations,screening of enough animal reference individuals,and sample collection and detection.The reference intervals should be verified in case of changes in the source of animal reference populations,sample collection conditions and detection systems.The test results should be analyzed in depth in terms of statistical,biological and toxicological significance based on the reference intervals.This review is expected to facilitate accurate and complete eualuation of the health status and drug-induced toxicity of laboratory animals.

关 键 词：药物安全性评价 实验动物 定量检测指标 参考值范围 

分 类 号：R965.3[医药卫生—药理学]