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流行病学资料在药物开发周期的作用:慢性偏头痛的案例研究

Role of Epidemiological Data within the Drug Development Lifecycle: A Chronic Migraine Case Study
课程网址: http://ocw.uci.edu/lectures/lecture.aspx?id=691  
主讲教师: Aubrey Manack
开课单位: 加州大学尔湾分校
开课时间: 2011-10-17
课程语种: 英语
中文简介:
2011年10月17日记录的公共卫生研讨会。制药行业的流行病学家除了应用概念和方法外,还使用描述性流行病学原理来评估药物在人群和临床试验环境中的影响,用途和效果。由于在任何药物的生命周期中存在广泛的数据需求和要求,因此在临床开发阶段特别使用的流行病学数据和方法的摘要(包括现实世界的例子)是及时的。本报告将提供一个案例研究,描述流行病学数据如何用于支持onabotulinumtoxinA(BOTOX®,Allergan,Inc.,Irvine,CA,USA)的登记,用于治疗慢性偏头痛成人的头痛。
课程简介: A public health seminar recorded on October 17, 2011. Epidemiologists working in the pharmaceutical industry use the principles of descriptive epidemiology in addition to applied concepts and methods to assess the impact, use and effects of drugs in the population and in clinical trial settings. As there is a wide spectrum of data needs and requirements during any drug's lifecycle, a summary, including a real-world example, of the epidemiological data and methods utilized specifically during clinical development phase is timely. This presentation will provide a case study describing how epidemiological data was used to support the registration of onabotulinumtoxinA (BOTOX®, Allergan, Inc., Irvine, CA, USA) for treatment of headaches in adults with chronic migraine.
关 键 词: 流行病学; 临床试验; 药物; 案例研究; 慢性偏头痛
课程来源: 加州大学尔湾分校公开课
最后编审: 2020-12-04:yumf
阅读次数: 31