[关键词]
[摘要]
病理学评估是药物非临床安全性评价的重要组成部分,也是确定和解释毒理学研究结果的重要依据。病理学同行评议是确保病理学评估和病理学报告质量的重要步骤。2019年7月,美国食品药品监督管理局(FDA)联合其下属6个中心编写并颁布了《非临床毒理学研究病理学同行评议指南草案》,以征求各界的意见或建议。美国毒性病理学会(STP)于2019年9月16日向美国FDA提交了电子版评论。就STP对FDA颁布的《非临床毒理学研究病理学同行评议指南草案》所做的一般性评论、6个关键主题的主要评论及其他方面的补充评论进行简要阐述,以期为我国药物非临床安全性评价机构更好地开展病理学同行评议提供一定参考。
[Key word]
[Abstract]
Pathological assessment is an important part of non-clinical safety evaluation of drugs, and also an important basis for determining and interpreting toxicological results. Pathology peer review is an important step to ensure the quality of pathology assessments and pathology reports. In July 2019, Food and Drug Administration (FDA) of the U.S., in conjunction with six centers, prepared and issued the "draft guidance on pathology peer review in nonclinical toxicology studies" to ask for comments or suggestions. The Society of Toxicologic Pathology (STP) submitted comments electronically to the FDA on September 16, 2019. In this paper, the general comments, principal comments on six critical topics and other ancillary comments of STP on the "draft guidance for pathology peer review in non-clinical toxicology studies" are briefly introduced in order to provide references for better performing pathology peer review in the field of nonclinical safety evaluation of drugs in China.
[中图分类号]
R951
[基金项目]
“十三五”重大新药创制专项(2018ZX09201017)