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临床前药物安全评价毒性病理学靶器官毒性的检查和评价要结合大体病理学、组织病理学及临床病理学检查结果进行全面考虑、逐步分析,并使用国际统一推荐的诊断术语及诊断标准,避免主观、不确切的诊断。简要介绍了临床前药物安全评价毒性病理学靶器官毒性检查的基本原则,大体病理学检查,组织病理学检查,毒性病理学诊断方法、程序及注意事项,诊断术语及诊断标准的国际统一,临床病理学参数分析,解剖病理学与临床病理学数据结合一致性分析等内容,以期为我国临床前药物安全评价毒性病理学靶器官毒性检查及评价提供一定参考。
Preclinical drug safety evaluation Toxic pathology The target organ toxicity examination and evaluation should be combined with gross pathology, histopathology and clinicopathological findings to fully consider and analyze step by step, and use internationally recommended diagnostic terms and diagnostic criteria to avoid Subjective, inaccurate diagnosis. The basic principles, general pathological examination, histopathological examination, toxicological pathology diagnostic methods, procedures and precautions, the international harmonization of diagnostic terms and diagnostic criteria, clinical Pathological parameters analysis, anatomical pathology and clinical pathology data consistency analysis and so on, with a view to China’s pre-clinical drug safety evaluation of toxicological pathology target organ toxicity test and provide some reference.