摘要
药物流行病学是把流行病学的方法、知识和推理应用到临床药理学中,并以此为基础对特定人群或特定药品的使用情况、有效性及安全性进行集中研究,在对药品进行研究和评价的过程中起着十分重要的作用。同时,药物流行病学与药品评价的应用研究已经贯穿于药品的整个研发、使用、甚至流通等诸多领域,直接为制定相关治疗指导原则、国家药品政策提供依据。本文从药物流行病学的历史和发展、药物流行病学常用的研究方法、药物流行病学和药品评价在药品审批和管理过程中的应用以及非政府组织对药物流行病学和药品评价研究的推动等方面入手,着重分析了药物流行病学和药品评价的国际现状。
Pharmacoepidemiology is application of epidemiologic methods, knowledge and reasoning to the subject of clinical pharmacology,whereby focusing on the study of specific people or specific drugs in terms of the use, effectiveness and safety,it plays a important role in the research and evaluation of drugs.Pharmacoepidemiology and drug evaluation have been involved in every field of drugs,including research,development,practice and marketing, etc.And,the results of research and evaluation have been applied to constituting policies and composing guidance. This article tells the history and evolution,the design methods of pharmacoepidemiology, the application in current drug approval and regulatory process.In addition,this article introduces how the non-government organizations push the development of pharmacoepidemiology and drug evaluation,and analyses the currentes international situation of pharmacoepidemiology and drug evaluation.
出处
《中国药物警戒》
2005年第3期131-136,140,共7页
Chinese Journal of Pharmacovigilance
关键词
药物流行病学
药品评价
不良反应
国际现状
Pharmacoepidemiology
Evaluation of drugs
Adverse reaction
International situation.
