非临床毒理学试验中组织病理学同行评议的GLP流程及关键点探讨
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摘要
组织病理学评估是非临床毒理学试验结果确定和解释的重要环节,组织病理学同行评议可确保病理学诊断术语的一致性、准确性及病理诊断的完整性,还可以提高组织病理学评估的准确性和病理学报告的质量。由于组织病理学同行评议过程需要考虑不同国家监管机构的GLP法规要求,因此有必要对组织病理学同行评议的GLP符合性、流程、条件和注意事项等进行深入理解和总结,以促进我国组织病理学同行评议的计划、管理、记录和报告与国外发达国家达成一致。从开展组织病理学同行评议的目的及必要性、组织病理学同行评议的GLP原则、适用于组织病理学同行评议的GLP质量体系、组织病理学同行评议的流程及条件以及组织病理学同行评议中的关键点进行阐述,以期为我国药物非临床安全性评价机构更好地开展组织病理学同行评议提供一定参考。
Histopathology assessment is an important step for the determination and interpretation of the results of nonclinical toxicology studies.Histopathology peer review can ensure the consistency,accuracy of pathological diagnosis terms and the completeness of pathological diagnosis,and can improve accuracy of histopathology assessment and the quality of pathology reports.Because the histopathology peer review processes need to be considered the requirements of the GLP regulations of different countries,therefore,it is necessary to deeply understand and summarize the GLP compliance,processes,conditions and considerations of histopathology peer review so as to promote the consistency in planning,conducting,documenting and reporting of the histopathology peer review in China with developed countries abroad as soon as possible.This article introduced the purpose and necessity of carrying out the histopathology peer review,the GLP principles of histopathology peer review,the GLP quality system applicable to the histopathology peer review,the processes and conditions of histopathology peer review,as well as the key points for the histopathology peer review,with the purpose of providing some references for better carrying out histopathology peer review in nonclinical safety evaluation facilities for drugs in China.
Histopathology assessment is an important step for the determination and interpretation of the results of nonclinical toxicology studies.Histopathology peer review can ensure the consistency,accuracy of pathological diagnosis terms and the completeness of pathological diagnosis,and can improve accuracy of histopathology assessment and the quality of pathology reports.Because the histopathology peer review processes need to be considered the requirements of the GLP regulations of different countries,therefore,it is necessary to deeply understand and summarize the GLP compliance,processes,conditions and considerations of histopathology peer review so as to promote the consistency in planning,conducting,documenting and reporting of the histopathology peer review in China with developed countries abroad as soon as possible.This article introduced the purpose and necessity of carrying out the histopathology peer review,the GLP principles of histopathology peer review,the GLP quality system applicable to the histopathology peer review,the processes and conditions of histopathology peer review,as well as the key points for the histopathology peer review,with the purpose of providing some references for better carrying out histopathology peer review in nonclinical safety evaluation facilities for drugs in China.
引文
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[4]Crissman J W,Goodman D G,Hildebrandt P K,et al Best practices guideline:toxicologic histopathology[J]Toxicol Pathol,2004,32(1):126-131.
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[6]Fikes J D,Patrick D J,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 Pathol2015,43:907-914.
[7]国家食品药品监督管理总局.国家食品药品监督管理总局令第34号药物非临床研究质量管理规范.[EBOL].(2017-07-27)[2017-08-02].http://www.sda.gov.cn WS01/CL0053/175598.html.
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[9]U.S.Food and Drug Administration.Good Laboratory Practice for Nonclinical Laboratory Studies;Proposed Rule,21 CFR.Part16 and 58.(2016-08-24)[2018-10-09].https://www.gpo.gov/fdsys/pkg/FR-2016-08-24/pdf/2016-19875.pdf
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[11]U.S.Food and Drug Administration.Good Laboratory Practices for Nonclinical Laboratory Studies(Advance Notice of Proposed Rulemaking),21 CFR Part 58[EB/OL].(2010-12-21)[2018-07-20].https://www.gpo.gov/fdsys/pkg/FR-2010-12-21/pdf/2010-31888.pdf
[12]Settiagounder N.Histopathology peer review for nonclinical studies-GLP processes and conditions[J].JRegul Sci,2017,5(2):56-66.
[13]Mann P C.Pathology peer review from the perspective of an external peer review pathologist[J].Toxicol Pathol,1996,24(5):650-653.
[14]Ward J M,Hardisty J F,Hailey J R,et al.Peer review in toxicologic pathology[J].Toxicol Pathol,1995,23(2):226-234.
[15]Organisation for Economic Cooperation and Development(OECD).Guidance document 116 on the conduct and design of chronic toxicity and carcinogenicity studies,supporting test guidelines 451,452 and 453:second edition,OECD series on testing and assessment,No.116[EB/OL].(2012-4-13)[2018-07-20].http://www.oecd-ilibrary.org/content/book/9789264221475-en.
[16]Organisation for Economic Co-operation and Development.OECD series on principles of good laboratory practice and compliance monitoring,number17.advisory document of the working group on good laboratory practice,application of GLP principles to computerised systems,ENV/JM/MONO(2016)13,1-33[EB/OL].(2016-04-22)[2018-10-09].http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2016)13&doclanguage=en.
[17]U.S.Food and Drug Administration.Electronic Records:Electronic Signatures,21 CFR PartⅡ[EB/OL].(1997-03-20)[2018-10-09].https://www.gpo.gov/fdsys/pkg/FR-1997-03-20/pdf/97-6833.pdf.
[18]Engelhardt J A,Hardisty J F,Mann P C.Regulatory forum opinion piece[J].Toxicol Pathol,2013,41(7):1051-1052.
[2]Organisation for Economic Cooperation and Development(OECD).OECD series on principles of good laboratory practice and compliance monitoring:No16,Advisory document of the working group on good laboratory practice guidance on the GLP requirements for peer review of histopathology[EB/OL].(2014-12-15)[2018-07-20].http://www.oecd-ilibrary.org/content book/9789264228306-en.
[3]吕建军,霍桂桃,林志,等.组织病理学同行评议的GLP要求及关注点探讨[J].中国药事,2018,32(4):485-493.
[4]Crissman J W,Goodman D G,Hildebrandt P K,et al Best practices guideline:toxicologic histopathology[J]Toxicol Pathol,2004,32(1):126-131.
[5]Morton D,Sellers R S,Barale-Thomas E,et al Recommendations for pathology peer review[J].Toxico Pathol,2010,38(7):1118-1127.
[6]Fikes J D,Patrick D J,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 Pathol2015,43:907-914.
[7]国家食品药品监督管理总局.国家食品药品监督管理总局令第34号药物非临床研究质量管理规范.[EBOL].(2017-07-27)[2017-08-02].http://www.sda.gov.cn WS01/CL0053/175598.html.
[8]U.S.Food and Drug Administration Considerations for use of histopathology and its associated methodologies to support biomarker qualification,Guidance for industry[EB/OL].(2016-05)[2018-10-08].https://www.fda.gov/downloads/drugs/guidancecomplicanceregulatoryinformation/guidances/ucm285297.pdf.
[9]U.S.Food and Drug Administration.Good Laboratory Practice for Nonclinical Laboratory Studies;Proposed Rule,21 CFR.Part16 and 58.(2016-08-24)[2018-10-09].https://www.gpo.gov/fdsys/pkg/FR-2016-08-24/pdf/2016-19875.pdf
[10]OECD series on Principles of Good Laboratory Practice and Compliance Monitoring,Number1.OECD Principles on Good Laboratory Practice(as revised in 1997),ENV/MC/CHEM(98)17,1-41[EB/OL].(1998-01-26)[2018-07-20].http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/mc/chem(98)17&doclanguage=en
[11]U.S.Food and Drug Administration.Good Laboratory Practices for Nonclinical Laboratory Studies(Advance Notice of Proposed Rulemaking),21 CFR Part 58[EB/OL].(2010-12-21)[2018-07-20].https://www.gpo.gov/fdsys/pkg/FR-2010-12-21/pdf/2010-31888.pdf
[12]Settiagounder N.Histopathology peer review for nonclinical studies-GLP processes and conditions[J].JRegul Sci,2017,5(2):56-66.
[13]Mann P C.Pathology peer review from the perspective of an external peer review pathologist[J].Toxicol Pathol,1996,24(5):650-653.
[14]Ward J M,Hardisty J F,Hailey J R,et al.Peer review in toxicologic pathology[J].Toxicol Pathol,1995,23(2):226-234.
[15]Organisation for Economic Cooperation and Development(OECD).Guidance document 116 on the conduct and design of chronic toxicity and carcinogenicity studies,supporting test guidelines 451,452 and 453:second edition,OECD series on testing and assessment,No.116[EB/OL].(2012-4-13)[2018-07-20].http://www.oecd-ilibrary.org/content/book/9789264221475-en.
[16]Organisation for Economic Co-operation and Development.OECD series on principles of good laboratory practice and compliance monitoring,number17.advisory document of the working group on good laboratory practice,application of GLP principles to computerised systems,ENV/JM/MONO(2016)13,1-33[EB/OL].(2016-04-22)[2018-10-09].http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2016)13&doclanguage=en.
[17]U.S.Food and Drug Administration.Electronic Records:Electronic Signatures,21 CFR PartⅡ[EB/OL].(1997-03-20)[2018-10-09].https://www.gpo.gov/fdsys/pkg/FR-1997-03-20/pdf/97-6833.pdf.
[18]Engelhardt J A,Hardisty J F,Mann P C.Regulatory forum opinion piece[J].Toxicol Pathol,2013,41(7):1051-1052.