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題名:新藥研發專案的預應式風險管理架構之研究
書刊名:科技管理學刊
作者:黃裕翔王瑞德 引用關係
作者(外文):Huang, Yu-hsiangWang, Juite
出版日期:2008
卷期:13:4
頁次:頁61-86
主題關鍵詞:風險管理新藥研發專案平衡計分卡品質機能展開Risk managementNew drug development projectBalanced scorecardQuality function deployment
原始連結:連回原系統網址new window
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  • 被引用次數被引用次數:期刊(1) 博士論文(0) 專書(0) 專書論文(0)
  • 排除自我引用排除自我引用:1
  • 共同引用共同引用:0
  • 點閱點閱:30
新藥研發由實驗室經過前臨床試驗、人體試驗到最後的藥物審核,往往需要十幾年的時間和數百億資金的需求;一旦失敗,有可能會造成企業倒閉的危機。有鑑於目前的新藥研發專案缺乏主動監控的風險管理模型,本研究藉由風險管理的相關研究,結合平衡計分卡與品質機能展開,提出預應式(proactive)風險管理的架構,由四個部份組成,(1)風險確認:應用平衡計分卡和品質機能展開的概念對指標進行質化分類,進而探討指標間關係的強弱程度。(2)風險評估與分析:分析各個透過模型計算而得的指標風險值,並按照其高低程度予以排序。(3)風險回應計劃:將分析結果應用於風險回應計劃之後,採取相關的因應行動。(4)風險監測與控制:對整個新藥研發流程的相關風險採取監控的方式,探究每個階段風險形成的原因,達到風險預應的效果。本研究貢獻如下,(1)結合平衡計分卡與品質機能展開的機制進行績效指標的質化分類,使新藥研發專案在衡量時能夠反應出組織的策略與目標進而達到預應的效果;(2)利用績效風險模型將風險量化以提供決策者做為主動監控的依據;(3)結合績效衡量系統提出預應式風險管理架構應用於生技製藥產業。
期刊論文
1.Bremser, W. G.、Barsky, N. P.(2004)。Utilizing the balanced scorecard for R&D performance measurement。R&D Management,34(3),229-238。  new window
2.Cooper, L. P.(2003)。A Research Agenda to Reduce Risk in New Product Development through Knowledge Management: A Practitioner Perspective。Journal of Engineering and Technology Management,20(1/2),117-140。  new window
3.Hauser, John R.、Clausing, Don(1988)。The house of quality。Harvard Business Review,66(3),63-73。  new window
4.Ogawa, S.、Piller, F. T.(2006)。Reducing the risks of new product development。Sloan Management Review,47(2),65-71。  new window
5.Kaplan, Robert S.、Norton, David P.(1992)。The Balanced Scorecard: Measures That Drive Performance。Harvard Business Review,70(1),71-79。  new window
6.Blau, G., Mehta, B., Bose, S., Pekny, J., Sinclair, G., Keunker, K.,、Bunch, P.(2000)。“Risk Management in the Development of New Product in Highly Regulated Industries”。Computer and Chemical Engineering,24(2),659-664。  new window
7.Blau, G. E., Pekny, J. F., Varma, V. A.,、Bunch, P. R.(2004)。“Managing a Portfolio of Interdependent New Product Candidates in The Pharmaceutical Industry”。Journal of Product Innovation Management,21,227-245。  new window
8.Boehm, B. W.、DeMarco, T.(1997)。“Software Risk Management”。IEEE Software,14,17-19。  new window
9.Browning, T. R., Deyst, J. J., Eppinger, S. D.,、Whitney, D. E.(2002)。“Adding Value in Product Development by Creating Information and Reducing Risk”。IEEE Transactions on Engineering Management,49(4),443-458。  new window
10.Bush, J. K., Dai, W. S., Dieck, G. S., Hostelley, L. S.,、Hassall, T.(2005)。“The Art And Science of Risk Management - A US Research-Based Industry Perspective”。Drug Safety,28(1),1-18。  new window
11.Drongelen, I. K.、Bilderbeek, J.(1999)。“R&D Performance Measurement: More Than Choosing a Set of Metrics”。R&D management,29(1),35-46。  new window
12.Gidel, T.、Gautier, R.、Duchamp, R.(2005)。Decision-Making Framework Methodology: An Original Approach to Project Risk Management in New Product Design。Journal of Engineering Design,16(1),1-23。  new window
13.Keizer, J. A., Vos, J. -P.,、Halman, J. I. M.(2005)。“Risks in New Product Development: Devising a Reference Tool”。R&D Management,35(3),297-309。  new window
14.Klees, J. E.、Joines, R.(1997)。“Occupational Health Issues in the Pharmaceutical Research and Development Process”。Occupational Medicine,12,5-27。  new window
15.Pass, D.、Postle, M.(2002)。“Unlocking the Value of R&D: Managing the Risks”。BioPharm,15(6),67-71。  new window
16.Rajapakse, A., Titchener-Hooker, N. J.,、Farid, S. S.(2005)。“Modeling of the Biopharmaceutical Drug Development Pathway and Portfolio Management”。Computers & Chemical Engineering,29(6),1357-1368。  new window
17.Raz, T., Shenhar, A. J.,、Dvir, D.(2002)。“Risk Management, Project Success, and Technological Uncertainty”。R&D management,32(2),101-109。  new window
18.Rogers, M. J., Gupta, A.、Maranas, C. D.(2002)。“Real Options Based Analysis of Optimal Pharmaceutical Research and Development Portfolios”。Industrial & Engineering Chemistry Research,41,6607-6620。  new window
19.Smith, P. G.(1999)。“Managing Risk as Product Development Schedules Shrink”。Research-Technology Management,42(5),25-32。  new window
20.Subramanian, D., Pekny, J. F., Reklaitis, G. V.,、Blau, G. E.(2003)。“Simulation-optimization framework for stochastic optimization of R&D pipeline management”。AICHE Journal,49(1),96-112。  new window
21.Sullivan, L. P.(1986)。“Quality Function Deployment”。Quality Progress,21(6),39-50。  new window
22.Williams, T. M.(1995)。“A Classified Bibliography of Recent Research Relating To Project Risk Management”。European Journal of Operational Research,85,18-38。  new window
研究報告
1.巢佳莉(2002)。「肝炎預防與治療藥物發展現況」。  延伸查詢new window
2.巢佳莉(2002)。「肝病相關醫藥與診斷最新進展」。  延伸查詢new window
3.陶光恆、曾念國(2004)。「生技公司研發技術及產品成功商業化之策略分析」。  延伸查詢new window
4.Saari, H. L.(2004)。“Risk Management in Drug Development Projects”。  new window
5.Zingales, F.、Hockerts, K.(2003)。“Balanced Scorecard and Sustainability: Example from Literature and Practice”。  new window
圖書
1.Kirkwood, Craig W.(1997)。Strategic Decision Making: Multiobjective Decision Analysis With Spreadsheets。Belmont:Duxbury Press。  new window
2.Chapman, C.、Ward, S.(1997)。Project risk management-Process, techniques and insights。New York:John-Wiley & Sons。  new window
3.行政院衛生署(1998)。「藥事法解釋彙編」。  延伸查詢new window
4.Edwards, P. J.、Bowen, P. A.(1998)。“Risk and Risk Management in Construction: A Review and Future Directions for Research”。  new window
5.Project Management Institute PMI(2000)。A Guide to the Project Management Body of Knowledge (PMBOK Guide)。PA。  new window
 
 
 
 
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