藥物流行病學
Pharmacoepidemiology
| 節 | 週二 |
|---|---|
5 13:20–14:10 | 藥物流行病學 YL405 2 節連堂 |
6 14:20–15:10 |
* 根據陽明交大上課時間表所列
透過課堂講授、文獻報告、專家演講讓同學們了解藥物流行病學常見研究設計與初級資料收集基本原理、重要方法學議題、在臺灣藥政領域的應用。
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| 週次 | 主題 |
|---|---|
| 第 1 週 | 09/02 Course overview and introduction to pharmacoepidemiology |
| 第 2 週 | 09/09 Studies of drug utilization and prescribing patterns |
| 第 3 週 | 09/16 Cohort studies and corresponding methodological considerations |
| 第 4 週 | 09/23 Studies of medication adherence |
| 第 5 週 | 09/30 Case studies* |
| 第 6 週 | 10/07 Case-control studies and corresponding methodological considerations |
| 第 7 週 | 10/14 Case studies* |
| 第 8 週 | 10/21 Case-only studies and corresponding methodological considerations (Note) |
| 第 9 週 | 10/28 Case studies* (Note) |
| 第 10 週 | 11/04 Comorbidity measures and control for confounding |
| 第 11 週 | 11/11 Special topic: Application of primary data collection in healthcare services research |
| 第 12 週 | 11/18 Randomized controlled trials |
| 第 13 週 | 11/25 Special topic: Spontaneous pharmacovigilance reporting system & postmarketing drug safety surveillance |
| 第 14 週 | 12/02 Special topic: Health technology assessment |
| 第 15 週 | 12/9 Group discussion: Target trial emulation |
| 第 16 週 | 12/16 Open book examination |
1. Pharmacoepidemiology. Brian L. Strom, Stephen E. Kimmel, Sean Hennessy. New York: Wiley-Blackwell. 6th ed., 2019. 2. International Society for Pharmacoepidemiology. Guidelines for Good Pharmacoepidemiology Practices (GPP). https://www.pharmacoepi.org/resources/policies/guidelines-08027 3. European Network of Centers for Pharmacoepidemiology and Pharmacovigilance. Guide on Methodological Standards in Pharmacoepidemiology. http://encepp.eu/standards_and_guidances/methodologicalGuide.shtml 4. US Food and Drug Administration. Framework for FDA’s real-world evidence program. https://www.fda.gov/media/120060/download 5. 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 6. European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) Module VIII – Post-authorisation safety studies (Rev 3) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129137.pdf 7. 授課教師指定參考教材