基于药物非临床安全性评价的毒性病理学同行评议流程及要求探讨

doi:10.19803/j.1672-8629.2020.11.09

中国药物警戒 ›› 2020, Vol. 17 ›› Issue (11): 790-793.
DOI: 10.19803/j.1672-8629.2020.11.09

基于药物非临床安全性评价的毒性病理学同行评议流程及要求探讨

李建华, 赵良友, 刘树民

黑龙江中医药大学药物安全性评价中心,哈尔滨黑龙江 150040

收稿日期:2020-11-10 修回日期:2020-11-10 出版日期:2020-11-15 发布日期:2020-11-10
通讯作者: ^*刘树民,男,教授,中药药效物质基础与中药药性理论。E-mail:Keji-Liu@163.com
作者简介:李建华,男,硕士,毒性病理学。
基金资助:
国家重点基础研究发展计划（2013CB531804）：基于利水功效的中药药性理论研究

Processes and Requirements of Peer Review of Toxicological Pathology Based on GLP

LI Jian Hua, ZHAO Liang You, LIU Shu Min

Drug Safety Evaluation Center of Heilongjiang University of Traditional Chinese Medicine, Harbin Heilongjiang 150040, China

Received:2020-11-10 Revised:2020-11-10 Online:2020-11-15 Published:2020-11-10

摘要/Abstract

摘要： 目的探讨毒性病理学同行评议的流程和要求,完善其内容以使同行评议更好地实施。方法以相关中英文关键词在中国知网、万方数据、Pubmed等数据库中进行检索,检索时间为1998年12月31日至2018年12月31日,对毒性病理学同行评议流程和要求的内容进行归纳总结与探讨。结果与结论 共检索相关文献12 657条,筛选其中文献22篇,通过文献查阅得出国内外毒性病理学同行评议的流程和要求的诸项条例基本相同,但我国规范的毒性病理学同行评议只包含条例而没有条例解释;国外毒性病理学同行评议已经施行,在实施过程中也对很多条例内容加以完善。

关键词: 毒性病理学, 同行评议流程, 同行评议要求, 病理学家

Abstract: Objective To explore the processes and requirements of peer review of toxicological pathology in order to ensure more effective peer review in China. Methods With "toxicological pathology" "peer review process" "peer review requirements" and "pathologist" as key words, the China HowNet、Wanfang、CNKI and Pubmed databases from December 1998 to December 2018 were searched to retrieve articles related to peer review processes and requirements of toxicological pathology before the content of these articles was analyzed and summarized. Results and Conclusion A total of 12,657 pieces of related literature were retrieved and 22 of them were screened out. Through literature review, it was concluded that the processes and requirements of peer review in the field of toxicological pathology were generally similar between China and other countries. However, in China's codes regarding peer review of toxicological pathology, only regulations are available, without any interpretations of these regulations. Peer review of toxicological pathology has been implemented abroad, and many regulations have been updated.

Key words: toxicological pathology, peer review process, peer review requirements, pathologists

中图分类号:

R994.1

李建华, 赵良友, 刘树民. 基于药物非临床安全性评价的毒性病理学同行评议流程及要求探讨[J]. 中国药物警戒, 2020, 17(11): 790-793.

LI Jian Hua, ZHAO Liang You, LIU Shu Min. Processes and Requirements of Peer Review of Toxicological Pathology Based on GLP[J]. Chinese Journal of Pharmacovigilance, 2020, 17(11): 790-793.

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基于药物非临床安全性评价的毒性病理学同行评议流程及要求探讨

Processes and Requirements of Peer Review of Toxicological Pathology Based on GLP

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