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安全性药理学试验的质量保证 被引量:2

Quality assurance of safety pharmacology tests
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摘要 安全性药理学(safety pharmacology)试验是最晚列入良好实验室规范(good laboratory practice,GLP)管理的毒理学试验。安全性药理学试验为多个小型试验的组合,涉及到多组生理功能的检测,在药品非临床研究质量管理规范和质量保证方面有其特殊性。该文从安全性药理学的定义和范围、研究内容、执行GLP的要求、实验室资质的确认、试验关键阶段的检查、原始资料和报告的审核等方面分析了安全性药理学试验质量保证的程序、要求和注意事项。 Safety pharmacology tests are the latest toxicological tests listed in the study categories regulated by the Good Laboratory Practice(GLP)Regulation.These studies consist of different types of small and short-term experiments involving examination of many groups of physiological functions.They have particularity in drug non-clinical research quality contral standard and Quality Assurance(QA).In the present article,the procedure,requirements,and some special concerns for the QA of the safety pharmacology tests are briefly outlined,with particular emphasis on the definition,scope and the GLP requirements of the safety pharmacology studies,qualifications of the safety pharmacology labs,the inspection of the critical study process,and the audit of the raw data and study reports.
出处 《军事医学科学院院刊》 CSCD 北大核心 2010年第2期184-186,共3页 Bulletin of the Academy of Military Medical Sciences
基金 国家重大新药创制科技重大专项(2008ZX09305-003)
关键词 安全性药理学 质量保证 药品非临床研究质量管理规范 safety pharmacology quality assurance good laboratory practice
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参考文献9

  • 1Vogel HG.Drug discovery and evaluation:safety and pharmacokinetic assays[M].Berlin:Springer-Verlag,2006:1-889.
  • 2Pugsley MK.Methodology used in safety pharmacology:appraisal of the state-of-the-art,the regulatory issues and new directions[J].J Pharmacol Toxicol Methods,2005,52(1):1-5.
  • 3Gad SC.Safety pharmacology in pharmaceutical development and approval[M].Boca Raton:CRC Press,2004:181.
  • 4The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)Har-monized Tripartite Guideline(S7A)[R] ,CPMP/ICH/539/00.Note for guidance on safety pharmacology studies for human pharmaceuticals,2001.
  • 5中华人民共和国食品药品监督管理局.药物非临床研究质量管理规范[S].2003.
  • 6中华人民共和国食品药品监督管理局.化学药物一般药理学研究技术指导原则[S].2005.
  • 7Benton MJ.Good laboratory practice and pharmacology[A].In Carson PA,Dent N,ed.Clinical,good laboratory and manufacturing practices:techniques for the QA professional[M].Cambridge:Royal Society of Chemistry,2007:271-277.
  • 8Spindler P,Seiler JP.Quality management of pharmacology and safety pharmacology studies[J].Fundam Clin Pharmacol,2002,16(2):83-90.
  • 9Bass AS,Siegl PKS,Gintant GA,et al.Current practices in safety pharmacology[A].In Gad SC,ed.Preclinical development handbook:toxicology[M] ,New Jersey:John Wiley & Sons,Inc.2008:611-694.

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