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FDA对抗菌药说明书有关微生物学的要求 被引量：1

FDA requirements on antibacterial labeling relating to microbiology
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摘要 目前我国抗菌药说明书有关微生物学的内容和形式参差不齐,问题不少,而我国至今尚无这方面的管理规章和指导原则,本文介绍美国食品药品监督管理局有关规章和指导原则中对抗菌药说明书有关微生物学的一些要求。期望对改进我国抗菌药说明书有帮助。 The contents and forms of antibacterial labeling relating to microbiology are uneven and have many problems at present in China.So far there have been no the management regulations and guidelines for this aspect.This article describes FDA requirements on antibacterial labeling relating to microbiology in relevant regulations and guidelines.It is expected to help to improve the antibacterial labeling in our country.
作者 萧惠来
机构地区 国家食品药品监督管理总局药品审评中心
出处 《中国抗生素杂志》 CAS CSCD 北大核心 2014年第11期875-880,共6页 Chinese Journal of Antibiotics
关键词 FDA 抗菌药 说明书 微生物学 要求 FDA Antibacterial Labeling Microbiology Requirement
分类号 R9 [医药卫生—药学]
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参考文献8

  • 1FDA.Guidance for Industry Microbiological Data for Systemic Antibacterial Drug Products-Development,Analysis,and Presentation (Draft).[EB/OL].(2009-09-17)(http://www.fda.gov/downloads/Drugs/GuidanceComplianc eRegulatoryInformation/Guidances/UCM 182288.pdf.).
  • 2FDA.Guidance for Industry Developing Antimicrobial Drugs-General Considerations for Clinical Trials (Draft).[EB/ OL].(1998-07-22)http://www.fda.gov/downloads/Drugs/Guidan ceComplianceRegulatoryInformation/Guidances/UCM070983.pdf.
  • 3CLSI.Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically.CLSI document M07-A#.[S].(Year).
  • 4CLSI.Informational Supplement.CLSI Document M100-S####.[S].(Year).
  • 5CLSI.Performance Standards for Antimicrobial Disk Susceptibility Tests.CLSI document M02-A#.[S].(Year).
  • 6CLSI.Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria.CLSI document M1 1-A#.[S].(Year).
  • 7FDA.Guidance for Industry Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Suscep-tibility Testing Devices[EB/OL].(2009-06-26)http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati on/Guidances/UCM 169359.pdf.).
  • 8MERCK.The prescribing information for PRIMAXIN I.V.(IMIPENEM AND CILASTATIN FOR INJECTION).[EB/OL].(2009-08-26) (http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050587s072,050630s0351b1.pdf.).

同被引文献10

  • 1CFDA.药品说明书和标签管理规定[EB/OL].http://www.sf-da.gov.cn/WS01/CID053/24522.html.2006-03-15.
  • 2CFDA.化学药品和治疗用生物制品说明书规范细则[EB/OL].http://www.sfda.gov.cr∥WS01/CID844/10528.html.2006-05-10.
  • 3国家食品药品监督管理局药品审评中心.化学药品、生物制品说明书指导原则(第二稿)[EB/OL].http://www.cde.org.en/zdyz.do?method=largePage&id=44.2004-03-01.
  • 4FDA. Guidance for industry labeling for human prescription drug and biological products -implementing the new content and format requirements [ EB/OL ]. http ://www. fda. gov/downloads/Drugs/Gui Information/Guidances/ ucm075082, pdf, 2006 -01 - 18.
  • 5FDA. Guidance for industry microbiological data for systemic anti- bacterial drug products - development, analysis, and presentation [EB/OL]. http://www, fda. gov/downloads/Drugs/Guidance- ComplianceRegulatorylnformation/Guidances/UCM 182288. pdf, 2009 - 09 - 17.
  • 6MERCK. The prescribing information for PRIMAXIN I. V. ( imi- penem and cilastatin for injection ) [ EB/OL ]. http ://www. ac- cessdata, fda. gov/drugsaffda _ docs/label/2009/050587s072, 050630s0351bl. pdf,2009-08-26.
  • 7PFIZER. The prescribing information for DIFLUCAN? (flucon- azole ) [ EB/OL ]. http://ll8. 26. 57. 18: 83/ 1Q2W3E4R5T6Y7U819OOP1Z2X3C4V5B/www. aeeessdata, fda. gov/drugsaffda _ does/label/2011/019949s055, 019950s059, 020090s0381bl. pdf,2011 - 11 - 16.
  • 8BRISTOL MYERS SQUIBB. The prescribing information for AZACTAM? (aztreonam for injection, USP) [ EB/OL]. http:// accessdata, fda. gov/drugsaffda _ does/label/2008/ 050580s040,050632s0131bl. pdf. 2008-01-22.
  • 9FDA. Guidance for Industry Updating labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Deviees[EB/OL]. http://www, fda. gov/down- loads/Drugs/GuidanceComplianceRegulatorylnformation UCM169359. pdf,2009-06-26. / Guidances/.
  • 10DR REDDYS LABS INC. The prescribing information for AUGMENTIN (amoxicillin/ clavulanate potassium) [EB/OL]. http://www, ac- eessdata, fda. gov/drugsatfda _ does/labal/2011/050575s039, 050597sO46,050725g)27,050726s0211bl. pdf,2011-09-29.

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中国抗生素杂志
2014年 第11期

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