期刊文献+

《抗菌药物临床试验专栏》的回顾与展望

Retrospection and expectation on special column of clinical trials of anti-bacterial drugs
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摘要 本文在全面回顾本刊《抗菌药物临床试验专栏》情况的基础上,提出了我国抗菌药物临床试验指导原则进一步发展的思考和建议。 This article is to retrospect Special Column of Clinical Trials of Anti - bacterial Drugs, and gives some considerations and suggestions to further development of the guidance for clinical trials of anti - bacterial drugs
出处 《中国临床药理学杂志》 CAS CSCD 北大核心 2009年第1期79-81,共3页 The Chinese Journal of Clinical Pharmacology
基金 国家863计划课题基金资助项目(2004AA2Z3430)
关键词 抗菌药物 临床试验 指导原则 anti - bacterial drug clinical trial guidance
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  • 1欧盟医药管理局.Clinical efficacy and safety guidelines [ EB/OL]. http ://www. emea. europa. eu/htms/human/humanguidelines/efficacy. htm,2008 -01 -05.
  • 2美国食品药品管理局. Guidances in FDA- regulated clinical trials [ EB/OL ]. http ://www. fda. gov/oc/gcp/guidance, html.
  • 3美国食品药品管理局. Guidances in FDA- regulated clinical trials [ EB/OL ]. http :// www. fda. gov/cder/guidance/index.htm, 2008 - 01 - 05.
  • 4世界卫生组织. Efficacy:good clinical practices (GCP) [ EB/OL]. http ://www. who. int/medicines/areas/quality_ safety/safety_efficacy/efficacy/en/index. html, 2008 - 01 - 05.
  • 5人用药品注册技术要求国际协调会. ICH guidelines [ EB/OL]. http ://www. ich. org/cache/compo/276 - 254 - 1. html, 2008 - 01 - 05.
  • 6Lewis EJ. Ancient clinical trials [ J ]. N Engl J Med, 2003 ; 348:83 - 84.
  • 7Grimes DA. Clinical research in ancient Babylon: methodologic insights from the book of Daniel [J]. Obstet Gynecol, 1995; 86:1031 - 1034.
  • 8Lepreau FJ. Clinical investigation in the 18th century [J]. N Engl J Med,2002 ; 347:692.
  • 9Macedo A, Farre M, Banos JE. Placebo effect and placebos: what are we talking about? Some conceptual and historical considerations [J]. Eur J Clin Pharmacol, 2003 ; 59:337 -342.
  • 10Moore SW. An overview of drug development in the United States and current challenges [J]. South Med J, 2003 ; 96 : 1244 - 1255.

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