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    Title: 新藥臨床實驗執行沿革與趨勢
    Analysis: Outlook on Pharmaceutical Industry Outsourcing Trends
    Authors: 廖珮君
    Liao, Debbie
    Contributors: 劉助
    Liu, James
    廖珮君
    Liao, Debbie
    Keywords: 臨床實驗
    Pharmaceutical Industry
    Outsourcing
    Date: 2012
    Issue Date: 2013-06-03 11:11:37 (UTC+8)
    Abstract: 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
    Reference: 【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
    Description: 碩士
    國立政治大學
    國際經營管理英語碩士學位學程(IMBA)
    95933005
    101
    Source URI: http://thesis.lib.nccu.edu.tw/record/#G0095933005
    Data Type: thesis
    Appears in Collections:[國際經營管理英語碩士學程IMBA] 學位論文

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