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| 研究生： |
廖珮君 Liao, Debbie |
|---|---|
| 論文名稱： |
新藥臨床實驗執行沿革與趨勢 Analysis: Outlook on Pharmaceutical Industry Outsourcing Trends |
| 指導教授： |
劉助
Liu, James |
| 學位類別： |
碩士
Master |
| 系所名稱： |
商學院 - 國際經營管理英語碩士學位學程(IMBA) International MBA Program College of Commerce(IMBA) |
| 論文出版年： | 2013 |
| 畢業學年度： | 101 |
| 語文別： | 英文 |
| 論文頁數： | 35 |
| 中文關鍵詞： | 臨床實驗 |
| 相關次數： | 點閱：54 下載：0 |
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The pharmaceutical and CRO industries are now very much interdependent on each other for the development of new drugs. This is an analysis on the changing trends of the conduct of clinical trials of new drugs in humans and the outsourcing options that are available. It is also an overview of how clinical trials are conducted in human subjects/patients.
1. Introduction 1
1.1. Pharmaceutical Industry Overview 1
1.2. Growth, Outlook and Challenges 3
1.2.1. Loss of Exclusivity 4
1.2.2. Innovation Crisis 4
2. Cost of Research and Development 6
3. Outsourcing Options 10
3.1. CRO – Overview and Outlook 10
3.2. Market Dynamics 11
3.3. Whom to Outsource? 15
4. Conducting a Clinical Trial 21
4.1. Overview – Phases 21
4.2. Process 25
4.2.1. Study Conduct 26
4.2.2. Clinical Study Protocol 27
4.2.3. Case Report Form 30
4.2.4. Regulatory Body Review 32
5. Conclusion 33
【1】 IMS Health, Phar,maceuticals and Biotech Industry Global Report 2011
【2】 H. Grabowski, J. Vernon, and J. DiMasi, “Returns on Research and Development for New Drug Introductions.” Pharmacoeconomics 20 (December 2002: suppl. 3, 11-29
【3】 Pharmaceuticals Research and Manufacturers of America, 2012
【4】 Tufts Center Report, Tufts CSDD R&D Management Reports
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