中国药物警戒 ›› 2020, Vol. 17 ›› Issue (11): 790-793.
DOI: 10.19803/j.1672-8629.2020.11.09
李建华, 赵良友, 刘树民
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:
LI Jian Hua, ZHAO Liang You, LIU Shu Min
Received:
2020-11-10
Revised:
2020-11-10
Online:
2020-11-15
Published:
2020-11-10
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。
中图分类号:
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.
[1] Liu L,Li B.Non clinical safety of vaccines[J].Chinese Journal of New Drugs(中国新药杂志),2018,27(21):2472-2481. [2] Yin JY,Wang HM,Qu WS, et al.Peer review of toxicity pathology based on the new "quality management standard for non clinical research of drugs"[J].Journal of International Pharmaceutical Research(国际药学研究杂志),2017,44(12):1085-1088. [3] Boorman GA, Haseman JK, Waters MD, et al.Quality Review Procedures Necessary for Rodent PathologyDatabases and Toxico-genomic Studies:The National Toxicology Program Experience[J]. Toxicol Pathol,2002,30(1):88-92. [4] Mann PC and Hardisty JH.Pathology working groups[J].Toxicol Pathol, 2014,42(1): 283-284. [5] Wang JN,Cao C.Discussion on standardization of pathology department in GLP institution[J].Drug Evaluation Research(药物评价研究),2011,34(4):241-243. [6] Standardization Administration of China.GB/T 22278-2008Principles of good laboratory practice(GB/T 22278-2008良好实验室规范原则)[M].Beijing: Standards Press of China,2008:8. [7] Melnick R,Lucier G,Wolfe M,et al.Summary of the National Toxicology Program′s report of the endocrine disruptors low-dose peer review[J]. Environ Health Perspect,2002,110(4):427-431. [8] Certification and Accreditation Administration of the Pe. RB/T193-2015 Guidelines for the application of good laboratory practice in peer review of histopathology (RB/T193-2015良好实验室规范在组织病理学同行评议中的应用指南)[M].Beijing: Standards Press of China,2016:4. [9] Liang AH,Han JY,Chen SL,et al.Quality and safety considerations of classical Chinese medicine prescriptions[J].China Food Drug Admi-nistration(中国食品药品监管),2018(6):4-10. [10] Ren SL,Peng L,Cheng SW,et al.Efficacy and safety of fluorouracil combined with paracetamol in the treatment of knee osteoarthritis[J]. China Pharmacy(中国药房),2019,30(2):249-252. [11] Zhang CL,Wang XC,Wang H,et al.Clinical observation of febuxostat in the treatment of type 2 diabetic nephropathy with hyperuricemia[J]. China Pharmacy(中国药房),2018,29(4):501-505. [12] Yoshitomi.Peer review in toxicologic histopathology: its necessity, type and procedure[J].Toxicol Sci,1998, 23(Supplement 1):1-9. [13] McLennan, Ludvik, Chambers, Frydenberg.Work after prostate cancer: a systematic review[J]. Cancer Surviv, 2019,13(2):282-291. [14] Lv JJ,Qu Z,Huo GT.Interpretation of guidelines for GLP requi-rements of OECD histopathology peer review[J].Chinese Pharma-ceutical Affairs(中国药事),2016,30(10): 968-976. [15] Fikes JD, Patrick DJ, Francke S, et al.Scientific and Regulatory Policy Committee Review: Review of the Organisation for Economic Co-operation and Development (OECD) Guidance on the GLP Requirements for Peer Review of Histopathology[J]. Toxicol Pathol, 2015,43(7):907-914. [16] Gupta,Rispin,Stitzel,Coecke,Harbell. Ensuring quality of in vitro alternative test methods: issues and answers[J].Regul Toxicol Pharmacol, 2005, 43(3):219-24. [17] Ward,Hardisty,Hailey,Streett.Peer review in toxicologic pathology[J]. Toxicol Pathol.1995, 23(2):226-34. [18] Mann PC.Pathology peer review from the perspective of an external peer review pathologist[J].Toxicol Pathol,1996,24(5):650-653. [19] Lv JJ,Huo GT,Lin Z,et al.Application of whole section image in histopathology peer review and pathology working group[J].Chinese Pharmaceutical Affairs(中国药事),2016,30(10):982-987. [20] Crissman JW, Goodman DG, Hildebrandt PK, et al.Best practices guideline: toxicologic histopathology[J].Toxicol Pathol,2004, 32(1):126-131. [21] Dong YS.Standardization construction and practice of toxicity pathology platform for drug safety evaluation[D].Academy of Military Medical Sciences,2012. [22] Eighmy JJ.Study Pathologist Perspective of Pathology Peer Review[J]. Toxicol Pathol, 1996, 24(5): 647-649. |
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