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目的:探讨如何甄别药物安全性评价试验中出现的异常数据。方法:以长期毒性试验的临床检验中依据GB/T 4833中Grubbs检验法检出的异常数据为例,对药物安全性试验中异常数据的分辨和保留进行讨论。结果:该数据虽然依Grubbs检验法检验为异常,但根据受试药物的资料和文献报道判断,该数据的变化是由药物引起的,不应作为异常数据剔除。结论:在药物安全性评价中,对异常数据的判断应结合受试药物的背景资料、相关文献报道以及实验室的相关背景数据进行综合判断分析,以保证药物安全性评价试验结果的真实可靠。
Objective: To explore how to identify abnormal data in drug safety evaluation test. Methods: In the long term toxicity test, the abnormal data of Grubbs test in GB / T 4833 were taken as an example to discuss the discrimination and retention of abnormal data in drug safety test. Results: Although the data were abnormal according to the Grubbs test, according to the information of the tested drugs and reported in the literature, the changes of the data were caused by drugs and should not be excluded as abnormal data. Conclusion: In the evaluation of drug safety, the judgment of abnormal data should be combined with the background information of the tested drugs, relevant literature reports and laboratory related background data to make a comprehensive judgment and analysis to ensure the authenticity of the drug safety evaluation test results.