請用此 Handle URI 來引用此文件:
http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/61739
完整後設資料紀錄
DC 欄位 | 值 | 語言 |
---|---|---|
dc.contributor.advisor | 林宗哲(Zhong-Zhe Lin) | |
dc.contributor.author | Kuan-Yu Chen | en |
dc.contributor.author | 陳冠佑 | zh_TW |
dc.date.accessioned | 2021-06-16T13:11:23Z | - |
dc.date.available | 2020-07-02 | |
dc.date.copyright | 2020-07-02 | |
dc.date.issued | 2020 | |
dc.date.submitted | 2020-06-22 | |
dc.identifier.citation | 中文 林建煌,(2013),行銷管理,第五版,臺北市,華泰。 林志六,(2008),新藥開發與臨床試驗,第一版,臺北市,秀威資訊。 賴源河,(2019),實用企業併購法,第二版,臺北市,五南。 賴景昌,林國仕,知識經濟,科學發展,337期,58-63頁。 羅國良,劉芳君,(2016),委託試驗服務之發展與市場趨勢簡析,財團發人農業科技研究院產業發展中心。 秦慶瑤,(2001),臨床試驗體系委外產業現況,財團法人生物技術開發中心 姚廷諺,(2014),CRO產業創新系統之研究,科技管理研究所碩士學位論文,國立交通大學。 楊士菁,(2012),以資源依賴理論探討新藥研發外包的服務整合-以藥明康德公司和昌達生物公司為例,科技管理學院高階經營管理碩士在職專班碩士學位論文,國立清華大學。 鍾曉芬,(2010),台灣臨床試驗服務公司 (CRO) 營運模式之探討- 以藥品研發為例,商學院經營管理碩士學程科技與創新組學位論文,國立政治大學。 鍾婉平,(2011),從智慧資本的觀點探討臨床試驗服務公司CRO之核心能耐,科技管理研究所碩士學位論文,國立政治大學。 邱青萸,(2005),臺灣藥物臨床試驗申請廠商對此環境觀點探討,健康管理研究所碩士學位論文,臺中健康暨管理學院。 邱琬婷,(2009),個人電腦產業併購之探討-惠普與宏碁併購案之比較,管理學院企業管理碩士學程碩士學位論文,國立交通大學。 黃河川,(2002),企業工作委外程度之影響因素分析-以國內生物科技廠商為例,工業管理研究所碩士學位論文,國立成功大學。 黃明國,黃梅芬,(2013),從併購理論探討醫療機構併購策略,醫院,第四十六卷 第一期,13-25頁。 黃子郁,(2010),企業購併績效之研究-以美商電子公司為例,商學院企業管理學系碩士在職專班碩士學位論文,東吳大學。 吳嘉凌,(2012),生物技術服務業發展策略之研究-以台灣委託研發機構之臨床試驗為例,高階經理人碩士在職專班學位論文,國立中興大學。 吳貞德,(2010),臨床研究委外機構_整合型資訊運作管理中心之個案研究,管理研究所EMBA碩士在職專班碩士學位論文,國立臺灣科技大學。 吳昌儒,(2015),醫療委外服務策略分析,科技管理研究所碩士學位論文,國立交通大學。 吳安妮,(1992),台灣企業併購動機之實證研究,管理評論,1-28頁。 吳承桓,(2017),併購如何創造綜效-以台灣與韓國為例,財務金融學系碩士學位論文,國立中央大學。 吳志明,朱素玥,方文昌,(2006),供應鏈關係中信任與承諾影響因素之研究-交易成本及社會交換理論觀點,資訊管理學報,第十三卷,91-118頁。 彭朱如,(2011),臨床試驗委託研究機構價值單元、資源優勢與策略之個案研究,商管專業學院碩士學位學程,國立政治大學。 趙玲珠,(2005),臨床試驗委託研究機構競爭策略之探討_以國際精鼎科技股份有限公司為例,經營管理研究所碩士學位論文,臺中健康暨管理學院。 黎班杰,(2018),藥物發展的開放式創新 以公司L與委託研究機構QPS為例,國際專業管理碩士班碩士學位論文,國立清華大學。 張弘欣,(2010),關係管理對研發委外作業績效影響之研究-以臺灣生技產業與委託研究機,科技管理研究所碩士學位論文,國立中興大學。 曾瑞鈴,(2009),學院資本主要下的美國生技醫藥產業:兼論台灣現況,社會科學論叢,第三卷第二期,119-154頁。 陳則銘,(2005),企業併購之相關智慧財產管理策略與法律規劃研究-以併購美國高科技公司時之專利查核評估探微,智慧財產研究所碩士學位論文,國立政治大學。 陳重安,(2011),政府契約委外的再檢視:目標、理論應用、績效衡量、與知識論基礎,公共行政學報,第四十期,111-143頁。 陳琪,(1993),美國反托拉斯法之簡介,公平交易季刊,第一卷第四期,45-67頁。 翁鶯娟,張昭基,(2017),併購與策略聯盟在公司理財文獻之回顧與展望:亞州市場之研究,台大管理論叢,第27卷第3期1-52頁。 翁崇雄,(1998),期望服務與服務績效影響服務品質評量之研究,臺大管理論叢,9(1),153-176頁。 江彥墅,(2006),企業併購決策因素分析之研究-以台灣上市櫃公司為例,資訊管理系EMBA碩士學位論文,國立臺灣科技大學。 徐碩彥,(2018),生物藥品委外生產趨勢,生技製藥暨食品科學院製藥碩士學位學程碩士學位論文,中國醫藥大學。 洪鳳儀,(2011),知識密集服務業之知識管理與服務創新的關聯性研究-以A法律事務所為例,商管專業學院碩士學位學程碩士學位論文,國立政治大學。 孫禎罄,(2015),知識密集型服務業的創新保護模式探討-以資訊服務業為例, 科技管理研究所碩士學位論文,國立清華大學。 藍月妏,(2018),藥品臨床試驗計畫審查流程精進措施與其實施成效,當代醫藥法規月刊,90,1-7頁。 譚雅芸,(2016),歐美日台早期臨床試驗計畫審查流程比較,當代醫藥法規月刊,69,1-8頁。 輝瑞,(2016),臺灣臨床試驗大未來,輝瑞杏苑,第10期,2-8頁。 財團法人生物技術開發中心,(2018),2018醫藥產業年鑑,臺北市,IT IS智網服務中心。 財團發人台灣經濟研究院,(2018),2018-2019產業技術白皮書,初版,臺北市,經濟部技術處。 英文 Alvesson, M. (1995). Management of knowledge-intensive companies. Berlin : New York , Walter de Gruyter. Anderson, E., Weitz, B. (1992). The use of pledges to build and sustain commitment in distribution channels. Journal of Marketing Research, 29(1), pp. 18-34. Arrow, K. J. (1984). The Economics of Agency. Stanford Institute for Economics Technical Reprt NO.451. Baláž, V. (2004). Knowledge-intensive business services in transition economies. The Service Industries Journal, 24(4), pp. 83-100. Barney, J. (1991). Firm resources and sustained competitive advantage. Journal of Management, 17(1), pp. 99-120. Berry, L. L. (1980). Services Marketing is Different. Business, Vol. 30, No. 3, pp. 24-29. Bettencourt, L. A., Ostrom, A. L., Brown, S. W., Roundtree, R. I. (2002). Client co-production in knowledge-intensive business services. California Management Review, 44(4), pp. 100-128. Betz, F. (1987). Managing Technology: Competing through New Ventures, Innovation, and Corporate Research. Englewood Cliffs, N.J., Prentice-Hall. Blau, P. M. (1964). Exchange and Power in Social Life. New York: John Wiley. Brinkley, I. (2006). Defining the knowledge economy. London: The work foundation, pp. 19. Cheon, M. J., Grover, V., Teng, J. T. (1995). Theoretical Perspectives on the Outsourcing of Information Systems. Journal of Information Technology, 10(4), pp. 209-219. Coase, R. H. (1937). The Nature of the Firm. The Economica Journal, 4(16), pp. 386-405. Dautel, V. (2015). L’adoption d’innovations technologiques et/ou organisationnelles dans la région métropolitaine de Luxembourg. Journal of Economie Prevision(1), pp. 71-90. DePamphilis, D. (2019). Mergers, acquisitions, and other restructuring activities: An integrated approach to process, tools, cases, and solutions. 10th ed., Academic Press. DiMasi, J. A., Hansen, R. W., Grabowski, H. G. (2003). The price of innovation: New estimates of drug development costs. Journal of Health Economics, 22(2), pp. 151-185. Dimitrios, N. K., Sakas, D. P., Vlachos, D. S. (2014). Modeling the scientific dimension of academic conferences. Journal of Procedia-Social and Behavioral Sciences, 147, pp. 576-585. Eisenhardt, K. (1989). Agency Theory: An Assessment and Review. Academy of Management Review, 14(1), pp. 57-74. Emerson, R. (1962). Power-Dependence Relations. American Sociological Review 27, pp. 31-41. Evaluate, (2017). EvaluatePharma®World Preview 2017, Outlook to 2022. www.evaluate.com/PharmaWorldPreview2017. Evaluate, (2019). EvaluatePharma®World Preview 2019, Outlook to 2024. www.evaluate.com/PharmaWorldPreview2019. Ganesan, S. (1994). Determinants of long-term orientation in buyer-seller relationships. Journal of Marketing, 58(2), pp. 1-19. Gibson, V. M. (1993). Outsourcing Can Save Money And Increase Efficiency. HR Focus, 70(3), pp.19-19. Grant, R. M. (1991). The resource-based theory of competitive advantage: implications for strategy formulation. California Management Review, 33(3), pp. 114-135. Hauknes, J., Antonelli, C. (1999). Knowledge intensive services–what is their role. Paper presented for the OECD Forum on Realising the Potential of the Service Economy, Paris, 28 September. Paris: OECD. Hertog, P. D. (2000). Knowledge-intensive business services as co-producers of innovation. International Journal of Innovation Management, 4(04), pp. 491-528. Homans, G. C. (1958). Social behavior as exchange. American Journal of Sociology, 63(6), pp. 597-606. Healthcare, (2019). CRO Sector M A Drivers and Market Trends. https://resultshealthcare.com/insight/cro-sector-drivers-and-market-trends/ Inkpen, A. C., Tsang, E. W. K. (2005). Social capital, networks, and knowledge transfer. Academy of Management Review, 30(1), pp. 146-165. Jensen, M. C., Meckling, W. H. (1976). Theory of the firm: Managerial behavior, agency costs and ownership structure. Economics Social Institutions, 3(4), pp. 305-360. John, G. (1984). An empirical investigation of some antecedents of opportunism in a marketing channel. Journal of Marketing Research, 21(3), pp. 278-289. Koch, A., Strotmann, H. (2008). Absorptive capacity and innovation in the knowledge intensive business service sector. Journal of Economics of Innovation and New Technology, 17(6), pp. 511-531. Kotler, P. (1994). Marketing management, analysis, planning, implementation, and control. 8th ed., Englewood Cliffs, N.J., Prentice-Hall. Kotler, P., Armstrong, G. (2013). Principles of Marketing. 16th Global Edition., Harlow, Pearson. Kotter, J. P. (1979). Managing external dependence. Academy of Management Review, 4(1), pp. 87-92. Laabs, J. J. (1993). Why HR is turning to outsourcing. Personnel Journal. 72(9), pp. 92-101. Larsen, J. N. (2000). Supplier-user interaction in knowledge-intensive business services: types of expertise and modes of organization. Services and the knowledge-based economy, London, New York: Continuum, pp. 146-154. Lee. J. N. (2001). The impact of knowledge sharing, organizational capability and partnership quality on IS outsourcing success. Information Management , 38(5), pp. 323-335. Lei, D., Hitt, M. A. (1995). Strategic restructuring and outsourcing: The effect of mergers and acquisitions and LBOs on building firm skills and capabilities. Journal of Management, 21(5), pp. 835-859. Mayer, R. C., Davis, J. H., Schoorman, F. D. (1995). An integrative model of organizational trust. Academy of Management Review, 20(3), pp. 709-734. McIvor, R. (2009). How the transaction cost and resource-based theories of the firm inform outsourcing evaluation. Journal of Operations Management, 27(1), pp. 45-63. Miles, I. (2016). Twenty years of service innovation research. Service Innovation, pp. 3-34. Miles, I., Kastrinos, N., Flanagan, K., Bilderbeek, R., Den Hertog, P., Huntink, W., Bouman, M. E. p. (1995). Knowledge-intensive business services: users, carriers and sources of innovation. European Innovation Monitoring Systems. EIMS Publication No 15. Innovation Programme, DGXIII, Luxembourg. Muller, E., Doloreux, D. (2009). What we should know about knowledge-intensive business services. Technology in Society, 31(1), pp. 64-72. Muller, E., Zenker, A. (2001). Business services as actors of knowledge transformation: the role of KIBS in regional and national innovation systems. Research Policy, 30(9), pp. 1501-1516. O'Farrell, P. N., Moffat, L. A. (1995). Business services and their impact upon client performance: an exploratory interregional analysis. Regional Studies, 29(2), pp. 111-124. OECD, (2017). OECD Science, Technology and Industry Scoreboard 2017-THE DIGITAL TRANSFORMATION. https://www.oecd.org/sti/oecd-science-technology-and-industry-scoreboard-20725345.htm OECD, (1999). OECD Science, Technology and Industry Scoreboard 1999- BENCHMARKING KNOWLEDGE-BASED ECONOMIES. https://www.oecd-ilibrary.org/industry-and-services/oecd-science-technology-and-industry-scoreboard-1999_sti_scoreboard-1999-en Penrose, E. (1959). The Theory of the Growth of the Firm. Oxford : Oxford University Press. Pfeffer, J., Salancik, G. (1978). The External Control of Organizations: A Resource Dependence Perspective. Harper Row, New York. Phan, P. H., Peridis, T. (2000). Knowledge creation in strategic alliances: Another look at organizational learning. Asia Pacific Journal of Management, 17(2), pp. 201-222. Prahalad, C. K., Hamel, G. (1997). The core competence of the corporation. Strategische Unternehmungsplanung/Strategische Unternehmungsführung pp. 969-987. Quinn, J. B., Hilmer, F. G. (1994). Strategic Outsourcing. MIT Sloan Management Review, 35(4), pp. 43. Rands, T. (1992). The key role of applications software make-or-buy decisions. The Journal of Strategic Information Systems, 1(4), pp.215-223. Ross, S. A. (1973). The economic theory of agency: The principal's problem. The American Economic Review, 63(2), pp. 134-139. Strambach, S. (2001). Innovation processes and the role of knowledge-intensive business services (KIBS). Innovation Networks, pp. 53-68. Toivonen, M. (2006). Future prospects of knowledge-intensive business services (KIBS) and implications to regional economies. ICFAI Journal of Knowledge Management, 4(3), pp. 18-39. Trautwein, F. (1990). Merger motives and merger prescriptions. Strategic Management Journal, 11(4), pp. 283-295. Wai Chow Lee, J., Mohamad, O., Ramayah, T. (2010). Outsourcing: Is the social exchange theory still relevant in developing countries? , Journal of Research in Interactive Marketing, 4(4), pp. 316-345. Williamson, O. E. (1979). Transaction-cost economics: the governance of contractual relations. The Journal of Law and Economics, 22(2), pp. 233-261. Williamson, O. E. (1973). Markets and hierarchies: some elementary considerations. The American Economic Review, 63(2), pp. 316-325. Williamson, O. E. (1987). Transaction cost economics: The comparative contracting perspective. Journal of Economic Behavior Organization, 8(4), pp. 617-625. Williamson, O. E. (2007). The economic institutions of capitalism. Firms, markets, relational contracting. Das Summa Summarum des Management, pp. 61-75. Wood, P. A., Bryson, J., Keeble, D. (1993). Regional patterns of small firm development in the business services: evidence from the United Kingdom. Environment and Planning A: Economy and Space, 25(5), pp. 677-700. Yourgenome, (2016). How are drugs designed and developed ? https://www.yourgenome.org/facts/how-are-drugs-designed-and-developed Yourgenome, (2016). What is a clinical trial ? https://www.yourgenome.org/facts/what-is-a-clinical-trial Zieba, M. (2013). Knowledge-intensive business services (KIBS) and their role in the knowledge-based economy Preliminary version. GUT Faculty of Management and Economics Working Paper Series A (Economics, Management, Statistics), 7, pp. 1-16. | |
dc.identifier.uri | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/61739 | - |
dc.description.abstract | 隨著全球人口快速攀升、人口老化和疾病種類增加,全球醫藥市場需求不斷增加且逐年成長,因此國際知名藥廠對新藥研發的投資皆是不遺餘力,然而在競爭激烈的產業環境驅使下,藥廠為了縮短新藥研發時程和減少支出成本,逐漸將研發、臨床試驗、製造和銷售等業務活動尋求專業性委外分工,促使臨床試驗委託研究服務業(Contract Research Organization, CRO)快速的成長。近年全球CRO企業將發展重心逐漸轉移至成本較低且人才資源豐富的亞太地區,同時台灣政府積極推動產業升級轉型,而生醫產業是政策重點發展產業之一;在全球新藥研發製造產業鏈中,CRO產業已是不可或缺的一環且其重要性與日俱增,台灣本土公司面對國際大型CRO企業和鄰近國家強烈的競爭下,需要不斷強化和擴展企業之核心能耐才能生存和增加競爭力。本研究透過文獻之收集和彙整探討CRO產業概況、商業流程委外之因素、知識密集服務業之特性以及CRO產業併購活動對於新藥研發流程之影響,並針對市場、政策、法規、人才培育和企業發展策略等面向,提出本研究對於台灣CRO產業發展策略之建議。 | zh_TW |
dc.description.abstract | A combination of rapid global population growth, population ageing and the increasing variety of diseases has spurred the global pharmaceutical market growth and expanding. The pharmaceutical companies have increased their investment in new drug research and development. In order to reduce R D costs and speeding up the time-to-market process, pharmaceutical companies tend to outsource projects such as R D, clinical trials, manufacturing and sales to other industries, and promote the high growth of the Contract Research Organization (CRO) industry. In recent years, international CRO companies focus on the development of the market because of the talent resources and low cost of Asia-Pacific region. Meanwhile Taiwan government also actively promotes industrial upgrading and transformation. The biomedical industry is one of the key policy development industries. CRO has become important partner to pharmaceutical and biotechnology companies in the development of new drugs. As fierce competition between CRO companies and neighboring countries, Taiwan's CRO companies necessary to continuously strengthen and expand the core competence of the corporate in order to increase their competitiveness and survival. In this study explores the CRO industry overview, the factors of business process outsourcing (BPO), the characteristics of knowledge-intensive business service (KIBS) industries, and the impact of M A activities of the CRO industry on the R D process of new drugs through the collection and compilation of the literature. Also aiming at the market analysis, policies, regulations, talent cultivation, and corporate development strategy, this study puts forward suggestions for the development strategy of Taiwan's CRO industry. | en |
dc.description.provenance | Made available in DSpace on 2021-06-16T13:11:23Z (GMT). No. of bitstreams: 1 U0001-2206202015265800.pdf: 3652954 bytes, checksum: 020030007a33726c2ec46a57ba733e41 (MD5) Previous issue date: 2020 | en |
dc.description.tableofcontents | 目錄 口試委員審定書 i 誌謝 ii 中文摘要 iii ABSTRACT iv 圖目錄 ix 表目錄 xi 第一章 緒論 12 第一節 研究動機與目的 12 第二節 研究範圍 14 第三節 研究方法 15 第四節 研究架構 16 第二章 新藥的研究和發展流程 17 第一節 新藥探索前期階段(Pre-discovery phase) 18 第二節 人體臨床試驗(Clinical trial phase) 21 第三節 新藥製造(Manufacturing) 23 第四節 第四期人體臨床試驗(Phase 4 Clinical Trial) 23 第三章 全球藥品市場和CRO產業發展現況 24 第一節 全球藥品銷售市場概況 24 第二節 全球醫藥研發投資概況 25 第三節 台灣藥品銷售市場概況 26 第四節 全球CRO產業發展概況 27 第五節 近年台灣與亞太鄰近國家新增臨床試驗案成長趨勢 30 第六節 台灣CRO企業 33 第七節 CRO企業併購活動 41 第四章 知識密集服務業:臨床試驗委託研究服務業 46 第一節 知識密集服務產業 (KNOWLEDGE-INTENSIVE BUSINESS SERVICES) 46 第二節 知識密集服務業之定義和分類 50 第三節 知識密集服務業與服務創新 53 第四節 小結 57 第五章 臨床試驗委託研究服務業興起之因素 59 第一節 商業流程委外 61 第二節 商業流程委外之定義 62 第三節 商業流程委外之決策理論 63 第四節 小結 72 第六章 全球CRO產業的併購潮 73 第一節 企業併購理論 73 第二節 企業併購之意義 74 第三節 企業併購的歷史發展 74 第四節 企業併購之種類 77 第五節 企業併購之動機 83 第六節 小結 86 第七章 結論與建議 88 第一節 研究結論 88 第二節 研究建議 92 參考文獻 97 | |
dc.language.iso | zh-TW | |
dc.title | 台灣臨床試驗委託研究服務業之發展策略探討 | zh_TW |
dc.title | A Study on the Development Strategy of Contract Research Organization in Taiwan | en |
dc.type | Thesis | |
dc.date.schoolyear | 108-2 | |
dc.description.degree | 碩士 | |
dc.contributor.coadvisor | 何佳安(Ja-An Ho) | |
dc.contributor.oralexamcommittee | 黃恆獎(Heng-Chiang Huang) | |
dc.subject.keyword | 臨床試驗,臨床試驗委託研究服務業,知識密集服務業,商業流程委外,策略, | zh_TW |
dc.subject.keyword | clinical trial,contract research organization (CRO),knowledge-intensive service industry (KIBS),business process outsourcing (BPO),strategy, | en |
dc.relation.page | 106 | |
dc.identifier.doi | 10.6342/NTU202001101 | |
dc.rights.note | 有償授權 | |
dc.date.accepted | 2020-06-23 | |
dc.contributor.author-college | 進修推廣學院 | zh_TW |
dc.contributor.author-dept | 生物科技管理碩士在職學位學程 | zh_TW |
顯示於系所單位: | 生物科技管理碩士在職學位學程 |
文件中的檔案:
檔案 | 大小 | 格式 | |
---|---|---|---|
U0001-2206202015265800.pdf 目前未授權公開取用 | 3.57 MB | Adobe PDF |
系統中的文件,除了特別指名其著作權條款之外,均受到著作權保護,並且保留所有的權利。