美国FDA生物等效性指导原则的修订与仿制药一致性评价
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摘要
目的介绍中国药学会翻译的美国FDA《特定药物的生物等效性指导原则》中涉及289目录的185个品种,从2016年6月至今的BE试验指导原则的更新情况,作为对已发布的中文翻译稿的补充。方法在FDA网站上对相关品种逐一进行检索,研究和分析有修订的10个品种和新增的2个品种的BE试验指导原则发生更新的可能原因。结果与结论美国FDA《特定药物的生物等效性指导原则》一直处于持续更新状态。在我国开展仿制药质量与疗效一致性评价的工作中,业内人士应密切关注其更新情况,及时获得最有价值的参考信息。
Objective To introduce updated versions of U. S. FDA Guidance for Industry Bioequivalence Recommendations for Specific Products including 185 products in 289 varieties from June 2016 till now, as supplements to the released Chinese versions translated by Chinese Pharmaceutical Association. Methods The related varieties were searched one by one on the FDA website, and the possible reasons for ten updated varieties and two new varieties of bioequivalence guidelines were studied and analyzed. Results and Conclusion U. S. FDA Guidance for Industry Bioequivalence Recommendations for Specific Products has been continuously updated. It should be paid close attention to the latest revision in the quality and effect consistency evaluation of generic drugs in China, and thus the most valuable reference information would be obtained in time.
Objective To introduce updated versions of U. S. FDA Guidance for Industry Bioequivalence Recommendations for Specific Products including 185 products in 289 varieties from June 2016 till now, as supplements to the released Chinese versions translated by Chinese Pharmaceutical Association. Methods The related varieties were searched one by one on the FDA website, and the possible reasons for ten updated varieties and two new varieties of bioequivalence guidelines were studied and analyzed. Results and Conclusion U. S. FDA Guidance for Industry Bioequivalence Recommendations for Specific Products has been continuously updated. It should be paid close attention to the latest revision in the quality and effect consistency evaluation of generic drugs in China, and thus the most valuable reference information would be obtained in time.
引文
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[23]FDA.Draft Guidance on Diazepam[EB/OL].(2018-9).https://www.fda.gov/downloads/Drugs/Guidance ComplianceRegulatoryInformation/Guidances/UCM619979.pdf.
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[28]Society of Japanese Pharmacopoeia.The Japanese PharmacopoeiaⅩⅦ[S].Tokyo:Society of Japanese Pharmacopoeia,2016:784-785.
[29]FDA.Draft Guidance on Morphine Sulfate[EB/OL].(2018-9).https://www.fda.gov/downloads/Drugs/Guidance ComplianceRegulatoryInformation/Guidances/UCM619997.pdf.
[30]崔静,白鑫,张晓霞,等.1例口服硫酸吗啡缓释片出现严重中枢神经系统不良反应患者的护理体会[J].当代护士,2017,5:145-146.
[31]龙海燕,李明,刘海燕.临床药师参与吗啡缓释片中毒救治的实践与体会[J].云南医药,2016,37(6):658-660.
[32]王慧,邱洪,林芳,等.硫酸吗啡缓释片致严重不良反应1例[J].中国药业,2015,24(9):123.
[33]张幸国,胡丽娜.临床药物治疗学各论(下册)[S].北京:人民卫生出版社,2015:267.
[2]FDA.Draft Guidance on chlorpromazine hydrochloride[EB/OL].(2018-9).https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM296739.pdf.
[3]FDA.Draft guidance on propafenone hydrochloride[EB/OL].(2017-7).https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM162469.pdf.
[4]FDA.Draft guidance on isosorbide dinitrate[EB/OL].(2018-11).https://www.fda.gov/downloads/Drugs/GuidanceCompl ianceRegulatoryInformation/Guidances/UCM436834.pdf.
[5]FDA.Guidance on diphenhydramine hydrochloride[EB/OL].(2017-8).https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UUC406261.pdf.
[6]FDA.Draft guidance on fluconazole[EB/OL].(2018-2).https://www.fda.gov/downloads/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/ucm086187.pdf.
[7]FDA.Draft guidance on valproic acid[EB/OL].(2017-8).https://www.fda.gov/downloads/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/UCM199683.pdf.
[8]FDA.Draft guidance on acetazolamide[EB/OL].(2018-9).https://www.fda.gov/downloads/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/UCM082347.pdf.
[9]FDA.Draft guidance ondigoxin[EB/OL].(2017-8).https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegul atoryInformation/Guidances/UCM085610.pdf.
[10]FDA.Draft guidance on nevirapine[EB/OL].(2017-5).https://www.fda.gov/downloads/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/ucm088753.pdf.
[11]FDA.Draft guidance on morphine sulfate[EB/OL].(2018-9).https://www.fda.gov/downloads/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/UCM533391.pdf.
[12]李俊.临床药理学(第6版)[S].北京:人民卫生出版社,2018:131.
[13]国家食品药品监督管理总局药品审评中心.国家药品监督管理局关于发布可豁免或简化人体生物等效性(BE)试验品种的通告(2018年第32号)[EB/OL].(2018-5-25).http://www.cde.org.cn/news.do?method=viewInfoCommon&id=314532.
[14]杨玉慧,许秀丽,朱珠.美国阿片类药物滥用及其治理举措概述[J].中国药物警戒,2017,14(12):746-751.
[15]FDA.General principles for evaluating the abuse deterrence of generic solid oral opioid drug products[EB/OL].(2017-11).https://www.fda.gov/downloads/Drugs/GuidanceCompl ianceRegulatoryInformation/Guidances/UCM492172.pdf.
[16]FDA.Draft guidance on warfarin sodium[EB/OL].(2012-12).https://www.fda.gov/downloads/Drugs/GuidanceCompl ianceRegulatoryInformation/Guidances/UCM201283.pdf.
[17]姚立新译,Lawrence X.YU,Bing V.Li著.FDA生物等效性标准[S].北京:北京大学医学出版社,2017:175.
[18]许文频,李丽,陈立勋,等.FDA/HC/EMA/PMDA/CFDA对口服固体制剂中窄治疗指数药物的仿制药人体生物等效性研究要求[J].中国新药杂志,2017,26(24):2913-2917.
[19]国家药典委员会.中华人民共和国药典[S].2015年版四部,北京:中国医药科技出版社,2015:360.
[20]国家食品药品监督管理总局.以药动学参数为终点评价指标的化学药物仿制药人体生物等效性研究技术指导原则[EB/OL].(2016-3-18).http://samr.cfda.gov.cn/WS01/CL1751/147583.html.
[21]FDA.CDER Product-Specific Guidances Withdrawn Listing[EB/OL].(2018-2-8).https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati on/Guidances/UCM422282.pdf.
[22]何春远,孙华,谢海棠.高变异药物生物等效性试验及量化评价[J].中国临床药理学与治疗学,2016,21(7):721-730.
[23]FDA.Draft Guidance on Diazepam[EB/OL].(2018-9).https://www.fda.gov/downloads/Drugs/Guidance ComplianceRegulatoryInformation/Guidances/UCM619979.pdf.
[24]国家食品药品监督管理总局.关于企业开展2 8 9目录内仿制药质量和疗效一致性评价基本情况信息[EB/OL].(2017-08-21).http://www.sfda.gov.cn/WS01/CL1757/176275.html.
[25]国家药典委员会.中华人民共和国药典[S].(2015年版二部)北京:中国医药科技出版社,2015:330-331.
[26]The United States Pharmacopeial Convention.USP40/NF35,Vol 3[S].Maryland:United Book Press,2016:3720.
[27]British Pharmacopoeia Commission Office.BP2018Updated[DB/OL]http://pip.juhe.com.cn/html/2/53/406019.html?date=2018-01-01#p2p03781.
[28]Society of Japanese Pharmacopoeia.The Japanese PharmacopoeiaⅩⅦ[S].Tokyo:Society of Japanese Pharmacopoeia,2016:784-785.
[29]FDA.Draft Guidance on Morphine Sulfate[EB/OL].(2018-9).https://www.fda.gov/downloads/Drugs/Guidance ComplianceRegulatoryInformation/Guidances/UCM619997.pdf.
[30]崔静,白鑫,张晓霞,等.1例口服硫酸吗啡缓释片出现严重中枢神经系统不良反应患者的护理体会[J].当代护士,2017,5:145-146.
[31]龙海燕,李明,刘海燕.临床药师参与吗啡缓释片中毒救治的实践与体会[J].云南医药,2016,37(6):658-660.
[32]王慧,邱洪,林芳,等.硫酸吗啡缓释片致严重不良反应1例[J].中国药业,2015,24(9):123.
[33]张幸国,胡丽娜.临床药物治疗学各论(下册)[S].北京:人民卫生出版社,2015:267.
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