課程名稱 |
藥物流行病學 Pharmacoepidemiology |
開課學期 |
109-2 |
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 |
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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213 |
備註 |
與張家勳合授 總人數上限:30人 |
Ceiba 課程網頁 |
http://ceiba.ntu.edu.tw/1092EPM7166_ |
課程簡介影片 |
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核心能力關聯 |
核心能力與課程規劃關聯圖 |
課程大綱
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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 |
Attend lectures, class presentation, homework, and a term paper |
預期每週課後學習時數 |
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Office Hours |
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指定閱讀 |
待補 |
參考書目 |
Optional textbook Strom, Kimmel, & Hennessy (eds). Textbook of
Pharmacoepidemiology, 2nd Edition. Sussex: Wiley, 2013
EMA Guideline on good pharmacovigilance practices (GVP) Module VIII – Post-
authorisation safety studies, VIII Appendix 1. Methods for post-
authorisation safety studies
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/20
12/06/WC500129137.pdf
ENCePP Guide on Methodological Standards in Pharmacoepidemiology
http://encepp.eu/standards_and_guidances/methodologicalGuide.shtml
Guidelines for Good Pharmacoepidemiology Practices (GPP)
https://www.pharmacoepi.org/resources/policies/guidelines-08027/
Guidance for Industry and FDA Staff -- Best Practices for Conducting and
Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare
Data
https://www.fda.gov/media/79922/download
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評量方式 (僅供參考) |
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週次 |
日期 |
單元主題 |
第1週 |
2/22 |
Course overview, introduction |
第2週 |
3/01 |
228紀念日 |
第3週 |
3/08 |
Medical product development and product life cycle |
第4週 |
3/15 |
Cohort studies |
第5週 |
3/22 |
Case control studies |
第6週 |
3/29 |
Case-crossover studies and self-controlled case series |
第7週 |
4/05 |
兒童節及清明節 |
第8週 |
4/12 |
Clinical trials and meta-analysis |
第9週 |
4/19 |
Comorbidity measures, bias, and confounding |
第10週 |
4/26 |
Pharmacovigilance |
第11週 |
5/03 |
Safety surveillance, safety signal detection & refinement |
第12週 |
5/10 |
Health data and related ethics considerations |
第13週 |
5/17 |
Drug utilization studies
Time series analysis
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第14週 |
5/24 |
Pharmacogenomic
Epidemiology in medical product development
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第15週 |
5/31 |
Regulatory decisions and therapeutic risk management |
第16週 |
6/07 |
Benefit-Risk Assessment
Real World Evidence
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第17週 |
6/14 |
端午節 |
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