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创新药药学研究的基本考虑和问题 被引量：4

Considerations on pharmaceutical research and development of innovative drugs
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摘要 创新药研发有其自身规律和研发思路,研究工作应按照其规律有序开展,审评应遵循其自身规律采取不同策略。目前由于经验有限,国内创新药研究和技术评价还存在一定问题。本文对近年来的工作进行了总结,参照FDA、EMEA发布的IND申请药学研究技术要求,介绍创新药药学研究的基本考虑和重要问题。 The research and development （R＆D） of innovative drugs should follow its own rules. The evaluation of innovative drugs should apply different strategies for investigational new drug applications （INDs）for phase 1, 2 and 3 and new drug application （NDA）. Due to limited knowledge and experiences, there are some problems on R＆D and evaluation of innovative drugs. This article is intended to introduce considera- tions and important issues on pharmaceutical research and development of innovative drugs, based on some experiences in innovative drugs evaluation and FDA and EMEA＇s guidelines on CMC information of INDs.
作者 王亚敏
机构地区 国家食品药品监督管理局药品审评中心
出处 《中国临床药理学杂志》 CAS CSCD 北大核心 2012年第8期637-640,共4页 The Chinese Journal of Clinical Pharmacology
关键词 创新药 药学研究 基本考虑 innovative drugs pharmaceutical research and develop-ment consideration
分类号 R954 [医药卫生—药学]
  • 相关文献

参考文献5

  • 1陈震,张培培.化学药物药学审评策略的探讨[J].中国临床药理学杂志,2011,27(10):812-816. 被引量：7
  • 2FDA. Guidance for Industry : Content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including well - characterized, therapeutic, biotechnology - derived products. [EB/OL]. http://www, fda. gov / downloads /Drugs /Guidance- ComplianceRegulatoryInformatiort/Guidances /UCM071597. pdf, 1995 -01 - 11.
  • 3FDA. Guidance for Industry: INDs for phase 2 and phase 3 studies. Chemistry, manufacturing, and controls Information. [ EB/OL ]. ht- tp ://www. fda. gov/downloads/Drugs /GuidanceComplianceRegula- torylnformatiort/Guidances/ucm070567, pdf,2003 - 05 - 20.
  • 4EMEA. Guideline on the requirements to the chemical and pharma- ceutical quality documentation concerning investigational medicinal products in clinical trials [ EB /OL]. http: //118. 26. 57. 16/1 Q2OP1Z2X3C4V5 B/www. emea. europa, eu/docs/en_GB/document _library/Scientidic'uideline/2009/O9/WC500003485. pdf, 2006 - 03 -31.
  • 5FDA. Guidance for Industry: CGMP for phase 1 investigational drugs. [EB/OL]. http: // www. fda. gov /downloads /Drugs /Guidance Compliance RegulatoryInformation/Guidances /ucm070273. pdf, 2008 - 07-20.

二级参考文献5

  • 1国家食品药品监督管理局.《药品注册管理办法》[EB/OL].http://www.sfda.gov.cn/WS01/CLD053/24529.html,2007-07-10.
  • 2FDA.Guidance for Industry:Content and Format of Investigational New Drug Applications(INDs)for phase 1 studies of drugs,including well-characterized,therapeutic,biotechnology-derived products[EB/OL].http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U CM071597.pdf,1995-01-11.
  • 3FDA.Guidance for Industry:INDs for phase 2 and phase 3 studies chemistry,nanufacturing,and controls information[EB/OL].http://www.fda.gov/downloads/Druga/GuidanceComplianceRegulatoryInformation/Guidances/ucm070567.pdf,2003-05-20.
  • 4国家食品药品监督管理局.《关于按CTD格式撰写化学药品注册申报资料有关事项的通知》[EB/OL].http://www.sfda.gov.cn / WS01 / CL0844 / 54391.htnl,2010-09-25.
  • 5张宁,平其能.浅谈我国仿制药研发与评价面临的理念挑战[J].中国药学杂志,2010,45(11):872-875. 被引量：11

共引文献6

同被引文献25

  • 1FDA. Guidance for Industry:Content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, Inclu- ding well-characterized, therapeutic, biotechnology-derived prod- ucts. [ EB /OL] [ 1995-01-11 ]. http://www, fda. gov/down- loads/Drugs /GuidanceComplianceRegulatorylnformation /Guid- ances/UCM071597, pdf.
  • 2FDA. Guidance for Industry:INDs for phase 2 and phase 3 stud- ies. Chemistry, manufacturing, and controls information. [ EB/ OL]. [ 20034)5-20 ] http://ww, fda. gov/downloads/Drugs/ GuidanceComplianceRegulatorylnformation/Guidances / ucm070567. Pdf.
  • 3EMA. Guideline on the requirements to the chemical and pharma- ceutical quality documentation concerning investigational medicinal products in clinical trials [ EB/OL 1 [ 2006-03-31 ]. http://118. 26. 57. 16/1Q20P1Z2X3C4V5B/www. emea. europa, eu/docs/ _ GB/document _ library/Scientidic _ guideline/2009/09/ WC500003485. pdf.
  • 4CDE, CFDA. Notice on requirements for CMC information of chemical drugs when applying 1ND [ EB /OL ] [ 2012-05-10 ]. http ://www. cde. org. cn/news, do? method =viewInfoCommon&id =312668.
  • 5颜耀东,黄晓洁,王楠.药品质量标准与药品质量评价相关性的探讨[J].中国药房,2007,18(34):2650-2652. 被引量：17
  • 6常福厚,白图雅,吕晓丽.药物毒理学研究的现状及与创新药物研究的关系[J].中国药理学与毒理学杂志,2013,27(3):488-489.
  • 7魏金锋,王风华,李海艳,等.GLP实验室质量管理体系的建立[J].中国药理学与毒理学杂志,2013,27(3):505.
  • 8Matthew OW, Judith AS, Stuart MM, et al. Post-market drug evaluation research training capacity in Canada: an environ- mental scan of Canadian educational institutions[J]. J Popul Ther Clin Pharmacol, 2014, 21(3):370-378.
  • 9]Varallo FR, Guimaraes Sde O, Abjaude SA, et al. Causes for the underreporting of adverse drug events by health profes- sionals: a systematic review[J]. Rev Esc Enferm USP, 2014, 48(4):739-747.
  • 10LaBute MX, Zhang X, Lenderman J, et al. Adverse drug re- action prediction using scores produced by large-scale drug- protein target docking on high-performance computing ma- chines[J]. PLoS One, 2014, 9(9):e106298. doi: 10.1371/jour- nal.pone.0106298, eCollection 2014.

引证文献4

二级引证文献8

中国临床药理学杂志
2012年 第8期

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