課程資訊
課程名稱
藥物流行病學
Pharmacoepidemiology 
開課學期
105-2 
授課對象
公共衛生學院  流行病學與預防醫學研究所  
授課教師
陳建煒 
課號
EPM7166 
課程識別碼
849 M0610 
班次
 
學分
2.0 
全/半年
半年 
必/選修
選修 
上課時間
星期一6,7(13:20~15:10) 
上課地點
公衛210 
備註
與張家勳合開
總人數上限:30人 
Ceiba 課程網頁
http://ceiba.ntu.edu.tw/1052EPM7166 
課程簡介影片
 
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課程概述

This is an introductory course on pharmacoepidemiology. How the principles of modern epidemiology methods are applied to evaluate safety, effectiveness, and utilization patterns of medical products (drugs, vaccines, and medical devices) will be discussed. Examples of descriptive epidemiology studies, cohort studies, case control studies, intervention studies, and meta-analysis will be drawn from recent literature to illustrate the application of relevant methods and the challenges in post-marketing medical product assessment. Perspectives from research institutions, medical product manufacturers, and regulatory agencies will be presented. Related topics, including therapeutic risk management, safety signal detection and refinement, data sources and ethics considerations, will be discussed. Advanced methodology, such as that utilized to address confounding by indication and misclassification will be briefly introduced. 

課程目標
To know how the principles of modern epidemiology methods are applied to evaluate safety, effectiveness, and utilization patterns of medical products (drugs, vaccines, and medical devices). 
課程要求
待補 
預期每週課後學習時數
 
Office Hours
 
參考書目
peer-reviewed research articles, commentaries, and FDA & EMA regulatory documents
Optional textbook Strom, Kimmel, & Hennessy (eds). Textbook of
Pharmacoepidemiology, 2nd Edition. Sussex: Wiley, 2013
FDA Guidance for Industry -- Good Pharmacovigilance Practices and
Pharmacoepidemiologic Assessment.
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdf

EMA Guideline on good pharmacovigilance practices (GVP) Module VIII –
Post-authorisation safety studies
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129137.pdf

Guidelines for Good Pharmacoepidemiology Practices (GPP) --
http://www.pharmacoepi.org/resources/guidelines_08027.cfm
 
指定閱讀
待補 
評量方式
(僅供參考)
   
課程進度
週次
日期
單元主題
第1週
2/20  Course overview, introduction, 文獻報告  
第2週
2/27  No class 
第3週
3/06  Medical product development and product life cycle 
第4週
3/13  Commonly used research methods in pharmacoepidemiology
Interventional and observational studies
 
第5週
3/20  Cohort studies 
第6週
3/27  Case-controls studies 
第7週
4/03  No class 
第8週
4/10  Case-crossover studies and Self-controlled case series 
第9週
4/17  Control for confounding and hierarchy of evidence 
第10週
4/24  Safety surveillance, safety signal detection & refinement 
第11週
5/01  Meta-analysis for safety assessment 
第12週
5/08  Health data and related ethical considerations
Drug utilization studies
 
第13週
5/15  Pharmacogenomic
Epidemiology in medical product development 
第14週
5/22  Pharmacy-based comorbidity measures
(Dr. 東雅惠, Yang Ming U) 
第15週
5/29  No class  
第16週
6/05  Regulatory decisions and therapeutic risk management 
第17週
6/12  Benefit-Risk assessment 
第18週
6/19  Final examination (optional)