药物非临床安全性评价解剖病理学数据差错原因和风险控制要点

Causes of error and key points for risk control in anatomic pathology data in nonclinical safety evaluation of drugs

在药物非临床安全性评价毒理学试验中,解剖病理学数据对受试物的后续临床试验和使用至关重要。解剖病理学数据主观性强,需要经验丰富的专题病理学家对相关数据进行综合分析,才能进行准确的诊断和书写合理的解剖病理学报告。而且需要专题负责人、专题监察员、毒理学家和专题病理学家加强交流和合作来减少差错和控制风险。简要介绍了解剖病理学数据差错原因和风险控制要点,以期为提高我国药物非临床安全性评价解剖病理学数据质量和风险控制提供一定参考。

In routine toxicology studies for nonclinical safety evaluation of drugs, anatomic pathology data are critical for subsequent clinical trials and use of test articles. Anatomic pathology data are subjective and require an experienced toxicologic pathologist to comprehensively analyze the relevant data in order to make accurate diagnosis and write a reasonable anatomic pathology report. Furthermore, it is necessary for study directors, study monitors, toxicologists and toxicologic pathologists to strengthen communication and collaboration to minimize errors and control risks. The paper briefly introduces causes of errors and key points for risk control in anatomic pathology data, in order to provide some references for improving the quality of the anatomic pathology data and risk control in nonclinical safety evaluation of drugs in China.