請用此 Handle URI 來引用此文件:
http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/38539
完整後設資料紀錄
DC 欄位 | 值 | 語言 |
---|---|---|
dc.contributor.advisor | 李吉仁 | |
dc.contributor.author | Chun-Ping Yang | en |
dc.contributor.author | 楊君萍 | zh_TW |
dc.date.accessioned | 2021-06-13T16:36:41Z | - |
dc.date.available | 2010-07-12 | |
dc.date.copyright | 2005-07-12 | |
dc.date.issued | 2005 | |
dc.date.submitted | 2005-07-06 | |
dc.identifier.citation | 參考文獻
梁容禎與高純琇,民93,九十二年度國內上市後藥物之ADR通報案例分析,藥物安全簡訊,5: 4-7。 蔡甫昌、朱怡康、黃天祥,民94,「遺傳檢測與諮詢的倫理議題與執業準則∼罹病傾向之遺傳檢測:以BRCA檢驗為例」,6月16日發表於「醫學倫理與法律」科技整合學術研討會第五場,該論文係國科會三年期研究計畫「遺傳諮詢的倫理原則與規則-以原則主義為進路」(NSC91-3112-H-002-004, NSC92-3112-H-002-006, NSC93-3112-H-002-008)。 吳凱琳 譯,民94,創新的兩難:企業面對新科技的掙扎與抉擇,台北:商周出版。 許恩得 譯,民93,競合策略:賽局理論的經營智慧,台北:台灣培生教育出版股份有限公司。 Acton, G. 2004a. Clinical genomics: The impact of genomic technology on clinical trials and medical practice. Newton Upper Falls, MA: Cambridge Healthtech Institute. Acton, G. 2004b. Toxicogenomics and Predictive Toxicology: Market and Business Outlook. Waltham, MA: Cambridge Healthtech Advisors. Belmont, J. W., & Gibbs, R. A. 2004. Genome-wide linkage disequilibrium and haplotype maps. Am J Pharmacogenomics, 4(4): 253-262. Besanko, D., Dranove, D., Shanley, M., & Schaefer, S. 2004. Economics of strategy (3rd ed.). Hoboken, NJ: John Wiley & Sons, Inc. Brandenburger, A. M., & Nalebuff, B. J. 1996. Co-opetition. New York, NY: Currency Doubleday. Chitta, R. 2004. Molecular diagnostics— A latest tool in diagnostics. San Antonio, TX: Frost & Sullivan. Cho, M. K., Illangasekare, S., Weaver, M. A., Leonard, D. G. B., & Merz, J. F. 2003. Effects of patents and licenses on the provision of clinical genetic testing services. Journal of Molecular Diagnostics, 5(1): 3-8. 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: 151-185. DiMasi, J.A. 2002. The value of improving the productivity of the drug development process: Faster times and better decisions. Pharmacoeconomics, 20(15) Supplement 3: 1-10. Evans, W. E. 2004. Pharmacogenetics of thiopurine S-methyltransferase and thiopurine therapy. Ther Drug Monit., 26(2):186-191. Fierz, W. 2004. Challenge of personalized health care: To what extent is medicine already individualized and what are the future trends? Med Sci Monit, 10(5): RA111-123. Flanagan, N. 2004. Tailored medicine no longer science fiction: Pharmacogenomics becomes integrated the drug discovery process. Genetic Engineering News, 24(15): 30 & 37. Frueh, F. W., & Gurwitz, D. 2004. From pharmacogenetics to personalized medicine: A vital need for educating health professionals and the community. Pharmacogenomics, 5(5): 571-579. Ginsburg, G. S., & McCarthy, J. J. (2001). Personalized medicine: Revolutionizing drug discovery and patient care. TRENDS in Biotechnology, 19(12): 491-496. Grabowski, H., Vernon, J., & DiMasi, J. 2002. Returns on research and development for 1990’s new drug introductions. Pharmacoeconomics, 20(15) Supplement 3: 11-29. Ho, R. J. Y., & Gibaldi, M. 2003. Biotechnology and biopharmaceuticals: Transforming proteins and genes into drugs. Hoboken, NJ: John Wiley & Sons, Inc. Ibarreta, D., Elles, R., Cassiman, J.-J., Rodriguez-Cerezo, E., & Dequeker, E. 2004. Towards quality assurance and harmonization of genetic testing services in the European Union. Nature Biotechnology, 22(10): 1230-1235. Israel, E., Drazen, J. M., Liggett, S. B., Boushey, H. A., Cherniack, R. M., Chinchilli, V. M., Cooper, D. M., Fahy, J.V., Fish, J. E., Ford, J. G., Kraft, M., Kunselman, S., Lazarus, S. C., Lemanske, R. F., Martin, R. J., McLean, D. E., Peters, S. P., Silverman, E. K., Sorkness, C. A., Szefler, S. J., Weiss, S. T., & Yandava, C. N. 2000. The effect of polymorphisms of the beta(2)-adrenergic receptor on the response to regular use of albuterol in asthma. Am J Respir Crit Care Med., 162(1): 75-80. Issa, A. M. 2002. Ethical perspectives on pharmacogenomic profiling in the drug development process. Nature Reviews Drug Discovery, 1: 300-308. Jain, K. K. 2004. Applications of biochips: From diagnostics to personalized medicine. Current Opinion in Drug Discovery & Development, 7(3): 285-289. Kohn, E. C., Lu, Y., Wang, H., Yu, Q., Yu, S., Hall, H., Smith, D. L., Meric-Bernstam, F., Hortobagyi, G. N., & Mills, G. B. 2004. Molecular therapeutics: Promise and challenges. Seminars in Oncology, 31(1) Suppl. 3: 39-53. Langheier, J. M., & Snyderman, R. 2004. Prospective medicine: The role for genomics in personalized health planning. Pharmacogenomics, 5(1): 1-8. Lazarou, J., Pomeranz, B., & Corey P. 1998. Incidence of adverse drug reactions in hospitalized patients. JAMA, 279: 1200-1205. Lemmens, N. (Ed.). 2004. Roche’s AmpliChip test gets EU approval: The AmpliChip CYP450 becomes the first pharmacogenomic microarray to receive the CE mark for diagnostic use. Pharmacogenomics, 5(7): 763. McGlennen, R. C. 2001. Miniaturization technologies for molecular diagnostics. Clinical Chemistry, 47(3): 393–402. McLeod, H. L., & Evans, W. E. 2001. Pharmacogenomics: unlocking the human genome for better drug therapy. Annu. Rev. Pharmacol. Toxicol. 41: 101–121. McLeod, H. L., & Siva, C. 2002. The thiopurine S-methyltransferase gene locus ― Implications for clinical pharmacogenomics. Pharmacogenomics, 3(1): 89-98. Medical Economics Company. 2000. Physicians' Desk Reference® (54th ed.). Montvale, NJ: Thomson PDR. Norton, R. M. 2001. Clinical pharmacogenomics: applications in pharmaceutical R & D. Drug Discov. Today, 6: 180–185. Nwanguma, B. C. 2003. The human genome project and the future of medical practice. African Journal of Biotechnology, 2(12): 649-656. Overend-Freeman, E. (Ed.). 2005. Will pharmacogenomics revolutionize clinical trials? New York, NY: Datamonitor. Pusztai, L., & Hess, K. R. 2004. Clinical trial design for microarray predictive marker discovery and assessment. Annals of Oncology, 15: 1731–1737. Rioux, P. P. 2000. Clinical trials in pharmacogenetics and pharmacogenomics: methods and applications. Am. J. Health Syst. Pharm. 57: 887–898. Rubenstein, K. 2004. Microarray: Technologies, applications, markets. Waltham, MA: Cambridge Healthtech Advisors. Schifreen, R. S., Storts, D. R., and Buller, A. M. 2002. The challenge of using SNPs in the understanding and treatment of disease. BioTechniques, 32: S14-S21. Shroff, A. P. 1998. Outsourcing trends in the biotech, pharmaceutical, and medical device industries― A regulatory perspective. Pharmaceutical Technology, 22(11): 60-66. Sindrup SH, & Brosen K. 1995. The pharmacogenetics of codeine hypoalgesia. Pharmacogenetics, 5(6):335-346. Tetlow, S. 2003. Successful pharmacogenomics business models. Newton Upper Falls, MA: Cambridge Healthtech Institute. The International HapMap Consortium. 2003. The international HapMap project. Nature, 426: 789-796. The International HapMap Consortium. 2004. Integrating ethics and science in the international HapMap project. Nature Reviews Genetics, 5: 467-475. The Pharmacogenetics Working Group. 2001. Terminology for sample collection in clinical genetic studies. The Pharmacogenomics Journal, 1: 101-103. Tishkoff, S. A., & Verrelli, B. C. 2003. Role of evolutionary history on haplotype block structure in the human genome: Implications for disease mapping. Current Opinion in Genetics & Development, 13: 569-575. Van den Oord, E. J. C. G., & Neale, B. M. 2004. Will haplotype maps be useful for finding genes? Molecular Psychiatry, 9: 227-236. 其他參考資料來源 行政院衛生署藥政處 公告,民94,多標的陣列平台基因診斷試劑¾查驗登記審查指引:以去氧核糖核酸標誌、變異及基因表現類多標的陣列平台診斷測試為例,http://www.doh.gov.tw/ufile/Doc/200503_microarray,Accessed April 26, 2005. 黃慧嫻,民94,基因檢測管理涉及之法制問題,http://stlc.iii.org.tw/doc/940221.ppt, Accessed April 19, 2005. Amgen. 2004. Amgen 2004 Annual Report. http://www.amgen.com/pdfs/Investors_2004_AnnualReport.pdf. Accessed June 22, 2005. AstraZeneca. 2004. Annual Report and Form 20-F Information 2004. http://www.astrazeneca.com/sites/7/imagebank/typearticleparam511562/astrazeneca-2004-annual-report.pdf. Accessed June 22, 2005. Branca, M. A. 2004a. Pharma Genomic Harvest: Part I Pfizer. http://www.bio-itworld.com/news/012904_report4257.html. Pfizer deal tables. http://www.bio-itworld.com/news/table.html. Bio-IT World (online). Accessed Jan. 29, 2004. Branca, M. A. 2004b. Pharma Genomic Harvest: Part II GlaxoSmithKline. http://www.bio-itworld.com/news/021304_report4399.html. GSK deal tables. http://www.bio-itworld.com/news/table021304.html. Bio-IT World (online). Accessed Feb. 13, 2004. Branca, M. A. 2004c. Pharma Genomic Harvest: Part III Merck. http://www.bio-itworld.com/news/031204_report4598.html. Merck genomics deals. http://www.bio-itworld.com/news/table021904.html. Bio-IT World (online). Accessed March 12, 2004. Branca, M. A. 2004d. Pharma Genomic Harvest: Part IV AstraZeneca. http://www.bio-itworld.com/news/051104_report5055.html. AstraZeneca deal tables. http://www.bio-itworld.com/news/table041604.html. Bio-IT World (online). Accessed May 11, 2004. Brandenburger, A., and Nalebuff, B. 1996. Co-opetition interactive. http://mayet.som.yale.edu/coopetition/index2.html. Accessed April 2, 2005. BusinessWeek online. 2005. Affymetrix to acquire ParAllele. http://www.businessweek.com/ap/financialnews/D8AECTF81.htm?campaign_id=apn_home_down. Accessed June 2, 2005. CenterWatch Newsletter. 2003. A Turning Point for Pharmacogenomics. http://www.centerwatch.com/bookstore/backissues/vol10iss12.html. Accessed June 16, 2004. Centers for Medicare & Medicaid Services. 2003. Health care industry market update. http://www.cms.hhs.gov/marketupdate. Accessed Oct. 12, 2003. Congressional Budget Office. 2004. Would prescription drug importation reduce U.S. drug spending? http://www.cbo.gov/ftpdocs/54xx/doc5406/04-29-PrescriptionDrugs.pdf. Accessed March 16, 2005. Davies, K. (Ed.). 2004. Merck and the Meta-Analysis. Bio-IT World. http://tmlr.net/jump/?c=0,8070,8073,,,,10987,10988,10989,10990&a=695&m=2696&p=1002269&t=212. Accessed Nov. 17, 2004. FDAAdvisoryCommittee.com. 2005a. Pfizer Camptosar To Serve As Example Of Pharmacogenetic Toxicity Risk. http://www.fdaadvisorycommittee.com/FDC/AdvisoryCommittee/Stories/1103-0404_BiomarkerP.htm. Accessed Nov. 5, 2004. FDAAdvisoryCommittee.com. 2005b. Iressa survival data adequately disseminated to physicians/patients. http://www.fdaadvisorycommittee.com/FDC/AdvisoryCommittee/Stories/030405_IressaR.htm. Accessed March 5, 2005. FDAAdvisoryCommittee.com. 2005c. J&J Zarnestra phase III data needed prior to approval. http://www.fdaadvisorycommittee.com/FDC/AdvisoryCommittee/Stories/050505_ZarnestraR.htm. Accessed May 6, 2005. FDAAdvisoryCommittee.com. 2005d. BI Aptivus needs further studies to guide use after accelerated approval. http://www.fdaadvisorycommittee.com/FDC/AdvisoryCommittee/Committees/Antiviral+Drugs/051905_aptivus/051905_AptivusR.htm. Accessed May 20, 2005. Genentech. 2004. Genentech 2004 Annual Report. http://www.gene.com/gene/ir/financials/annual-reports/2004/2004annualreport.pdf. Accessed June 22, 2005. GenomeWeb News. 2003. Affymetrix to Supply ParAllele Biosciences with GeneChip Arrays. http://www.genomeweb.com/articles/view.asp?Article=2005531174137. Accessed March 20, 2003. GenomeWeb News. 2004a. Affymetrix to Distribute ParAllele's Genotyping Products. http://www.genomeweb.com/articles/view.asp?Article=2005531174137. Accessed May 21, 2004. GenomeWeb News. 2004b. Affy, basking in AmpliChip approval, signs J&J Unit as IVD customer. http://www.genomeweb.com/articles/view.asp?Article=200412289331. Accessed Dec. 28, 2004. GenomeWeb News. 2005. Affy to Buy ParAllele for $120M in Stock; Deal Expected to Close in Q3. http://www.genomeweb.com/articles/view.asp?Article=2005531174137. Accessed June 2, 2005. Gillings, D. 2004. Pharmacogenomics and the Role of CROs. Quintiles Transnational Corp. http://www.quintiles.com/Performance/Presentations.htm?year=2004. Accessed Nov. 22, 2004. Harris, G. 2005a. F.D.A. Is Advised to Let Pain Pills Stay on Market. http://www.nytimes.com/2005/02/19/politics/19fda.html?ex=1113019200&en=bcdd8c18b53b0786&ei=5070&th. Accessed Feb. 19, 2005. Harris, G. 2005b. F.D.A. to Create Advisory Board on Drug Safety. Feb. 16, Late Edition - Final , Section A , Page 1 , Column 1. New York, NY: The New York Times Company. Huml, R. 2002. Pharmacogenomics Role in Drug Development: A regulatory development: a regulatory perspective. Quintiles Transnational Corp. http://www.quintiles.com/NR/rdonlyres/ey76az5vj2aeep4mk6qxdh4kc2rrnmkarudx5w5wofhz64vq5k3yo5hg6oarf4odvkoswpdclmpde56adelbvfya3pc/rhumldec02.pdf. Accessed Dec. 21, 2004. Khaleeli, N., & Fernandez, D. 2003. Patent prosecution in pharmacogenomics. http://www.iploft.com/NU-Pharmaco.pdf. Accessed Jan. 14, 2005. Khaleeli, N., & Fernandez, D. 2004. The promise of pharmacogenomics. http://www.larta.org/lavox/articlelinks/2004/041206_pharma.asp. Assessed Jan. 14, 2005. Krochmal, M. 2005. With Roche's Key PCR Patents Now Expired, What is Upshot for Genomics? http://www.genomeweb.com/articles/view.asp?Article=20053299350. Accessed March 29, 2005. Landers, P. 2003. Cost of developing a new drug increases to about $1.7 Billions. The Wall Street Journal, Dec. 8. Lesko, L. J. 2004. Regulatory perspective on integrating pharmacogenomics into drug development and regulatory decision-making. http://www.fda.gov/cder/genomics/presentations/PSWC.pdf. Accessed Nov. 23, 2004. Navigant Consulting, Inc. 2003. Pharmacogenomics: A strategic market outlook and business analysis. http://www.navigantconsulting.com/lifesciences/SMR/pgenom/pgenomTOC.pdf. Accessed Nov. 22, 2004. Navigant Consulting, Inc. 2004. Nucleic acid testing. http://www.navigantconsulting.com/lifesciences/SMR/nat/natSP.pdf. Accessed Nov. 22, 2004. Novartis. 2004. 2004 Annual Report. http://www.novartis.com/downloads/annual_reports/AR04_full.pdf. Accessed June 22, 2005. Otte. A. 2004. The evolving relationship between pharma/biotechnology companies and CROs. http://www.jcroa.gr.jp/pdf/2004/sympo04_3_1.pdf. Accessed March 7, 2005. Perlegen Sciences, Inc. 2005. Perlegen Sciences licenses late-stage compound from Mitsubishi Pharma: Companies usher in new era of personalized medicines in metabolic disease. http://www.perlegen.com/index.htm?newsroom/pr/2005/2005_04_12_MCC-555_Joint_Press_Release.htm. Accessed April 15, 2005. PhRMA. 2003. Pharmaceutical Industry Profile 2003. http://www.phrma.org/publications/publications/profile02/. Washington, DC: Pharmaceutical Research and Manufacture Association. PricewaterhouseCoopers. 2005. Personalized medicine: The emerging pharmacogenomics revolution. http://www.pwc.com/techforecast/pdfs/pharmaco-wb-x.pdf. Accessed March 20, 2005. Santicerma, A. J., Engelhart, M. M., & Harvey, M. H. 2004. The future of clinical diagnostics: Pharmaceutical industry trends will directly impact the clinical diagnostic world, resulting in a more integrated therapeutic strategy. http://www.actmagazine.com/appliedclinicaltrials/content/printContentPopup.jsp?id=125728. Accessed Nov. 12, 2004. Siitari, H. 2002. Nucleic acid diagnostics market: Unmet needs and product potential. Technology Review 125/2002. Helsinki: Tekes. http://www.tekes.fi/english/publications. Accessed Nov. 22, 2004. The Associated Press. 2005. Merck announces resignation of chief and names replacement. http://www.nytimes.com/aponline/business/AP-Merck-CEO.html?ei=5094&en=8cc17495ab8ade1d&hp=&ex=1115352000&partner=homepage&pagewanted=print. The New York Times Company. Accessed May 6, 2005. U.S. Food and Drug Administration. 2003a. Analyte specific reagents; small entity compliance guidance; guidance for industry. http://www.fda.gov/cdrh/oivd/guidance/1205.pdf. Accessed Nov. 12, 2003. U.S. Food and Drug Administration. 2003b. Guidance for industry pharmacogenomic data submissions (draft guidance). http://www.fda.gov/cder/guidance/5900dft.pdf. Accessed Nov. 12, 2003. U.S. Food and Drug Administration. 2005a. Attachment to guidance on pharmacogenomic data submissions: Examples of voluntary submissions or submissions required under 21 CFR 312, 314, or 601. http://www.fda.gov/cder/guidance/6400fnlAttch.pdf. Acessed March 23, 2005. U.S. Food and Drug Administration. 2005b. Genomics at FDA. http://www.fda.gov/cder/genomics/default.htm. Accessed March 22, 2005. U.S. Food and Drug Administration. 2005c. Guidance for industry and FDA staff: Class II special controls guidance document― Drug metabolizing enzyme genotyping system. http://www.fda.gov/cdrh/oivd/guidance/1551.pdf. Accessed March 11, 2005. U.S. Food and Drug Administration. 2005d. Guidance for industry pharmacogenomic data submissions. http://www.fda.gov/cder/guidance/6400fnl.pdf. Acessed March 23, 2005. U.S. Food and Drug Administration. 2005e. Drug- diagnostic concept paper: Draft (not for implementation). http://www.fda.gov/cder/genomics/pharmacoconceptfn.pdf. Accessed April 11, 2005. Uyama, Y. 2004. Current situations of pharmacogenomics in Japan. http://www.jpma.or.jp/news/pdf/040716_04.pdf. Accessed March 1, 2005. Womack, C. 2005. Lilly and ParAllele to launch Affy-based drug-metabolism genotyping assay in August or September. http://www.genomeweb.com/articles/view.asp?Article=200531713221. Accessed March 18, 2005. | |
dc.identifier.uri | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/38539 | - |
dc.description.abstract | 科技的創新常是造成產業生態改變的重要因素,而創新科技的管理更是企業是否能夠成功掌握新市場脈動的關鍵。無論是從企業內部建立創新能耐,或是從外部借重創新資源,皆考驗著高階經理人之遠見與經營策略。尤其是當新市場正在發展初期,企業如何運用競合策略來開拓市場機會,更是產業發展與企業成長之關鍵考量。
藥物基因體學(簡稱PGx)是研究人體基因如何影響個人對藥物反應之差異性的新興科學。Genentech用於治療乳癌藥物Herceptin的成功,顯示出應用PGx有助於新藥開發經濟效益的提升與個人化醫療之發展。然而,PGx營運模式仍處於發展階段,無論是在市場規模或產品最終應用上,皆充滿高度不確定性與挑戰。 本論文係以生技醫藥產業為研究範圍,探討PGx的應用對於生技醫藥產業之發展產生哪些潛在效益;並希望透過產業結構分析與競合策略等理論架構,來進一步解析PGx應用如何影響生技醫藥產業結構與競合動態。本研究係以產業層次分析為主,以理論輔助強化推論的邏輯性,並據以提出競合結構下攸關廠商的營運策略、以及相關產業發展政策之建議。 本研究首先從新藥開發價值鏈出發,就技術面、市場面、與法規面建立推論模型,並輔以文獻資料作為佐證,歸納得知PGx應用可產生「提升新藥開發之經濟效益」與「發展個人化醫療」等兩項潛在效益。接著,藉由PGx成功個案歸納出,PGx應用改變「產品開發模式」與「廠商競合模式」,並透過新藥開發價值鏈分析PGx商品化之成功關鍵與市場機會。最後,本研究透過Roche、Affymetrix、與ParAllele三個案之價值網分析,探討PGx賽局中各參賽者之策略考量。本研究發現,業內領導廠商對於PGx應用應以委外策略為主,而新進廠商積極採取PGx策略將具有先佔優勢。最後,本文分別針對實務面以及後續研究提出策略性建議。 | zh_TW |
dc.description.abstract | Techology innovation is one of the critical factors triggering the emergence of new market opportunities, which results in the changes of industry landscape. Facing potential industry changes, a firm has to figure out how to strategically manage technological innovation in order to capture opportunities of value creation.
Pharmacogenomics (PGx) is a field of knowledge dealing with how genes affect the way individuals respond to drugs. Genentech's Herceptin is the successful example of applying PGx-based approaches to drug development. The drug was approved around eight years sooner than the average blockbuster, with estimated US$35 million saving on the costs of clinical trials and an estimated US$2.5 billion on revenue generation during that eight-year period. Despite its promise to both the improvement of the efficiency of new drug development and the facilitatation of personalized medicine, PGx faces significantly technical, financial, and commercial challenges before it can be broadly applied to clinical practices. A final hurdle will be overcoming industry doubts that a business model exists for PGx. Overall, given the situation that pharmaceutical companies still have a dominant thinking on blockbuster drugs, the idea of creating a nitch market for a new therapeutic would be not so attractive. The purpose of this thesis is to explore what and how the potential impact of applying PGx in biomedical industry is, with a special emphasis on its impact on the co-opetition dynamics among various value-net players. First, we analyze what kinds of potential benefits result from PGx applications along the value chain of drug discovery. We found that PGx applications not only improve the efficiency of new drug development but also facilitate personalized medicine. Next, based on several successful cases, we further indicate that PGx applications could change both product development model and companies’ co-optition structure. To further discuss effective strategies responding to the development of PGx applications, we provide rather detailed analysis on the collaborations among Roche, Affymetrix, and ParAllele. Based on the case study, we propose that it would be an win-win collaboration between incumbents and PGx specialists in capturing value creation based on PGx applications. Strategic implications and policy suggestions are also discussed. | en |
dc.description.provenance | Made available in DSpace on 2021-06-13T16:36:41Z (GMT). No. of bitstreams: 1 ntu-94-R90724089-1.pdf: 1779548 bytes, checksum: 22718e1e99574981ed70311140b2744a (MD5) Previous issue date: 2005 | en |
dc.description.tableofcontents | 目錄
謝 辭--------------------------------------------------I 中文摘要-------------------------------------------------II Thesis Abstract-----------------------------------------III 目 錄-------------------------------------------------IV 表 目 錄--------------------------------------------------V 圖 目 錄-------------------------------------------------VI 附 錄 目 錄---------------------------------------------VII 第一章 緒 論--------------------------------------------1 第一節、 研究背景與動機-----------------------------------1 第二節、 研究問題與目的----------------------------------10 第三節、 研究方法----------------------------------------13 第四節、 論文章節架構------------------------------------15 第二章 文獻探討------------------------------------------16 第一節、 產業結構分析------------------------------------16 第二節、 賽局理論與競合策略------------------------------18 第三節、 科技創新對產業的影響----------------------------25 第三章 藥物基因體學與生技醫藥產業應用分析---------------27 第一節、 藥物基因體學(PGx)的內涵-----------------------27 第二節、 PGx應用於生技醫藥產業之潛在效益分析-------------30 第三節、 PGx應用對於新藥開發模式潛在效益之探討-----------33 第四節、 PGx法規驅動個人化醫療之發展---------------------36 第四章 藥物基因體學對生技醫藥產業結構之影響-------------40 第一節、 PGx策略之成功模式分析---------------------------40 第二節、 PGx應用對於產品開發模式影響之探討---------------44 第三節、 廠商的競合關係分析------------------------------51 第四節、 競合模式之個案分析------------------------------58 第五章 結論與建議 ---------------------------------------70 第一節、 研究結論與意涵----------------------------------70 第二節、 未來展望與建議----------------------------------73 參考文獻-------------------------------------------------76 其他參考資料來源-----------------------------------------80 附 錄-------------------------------------------------86 表 目 錄 表1-1、藥物治療與藥效反應---------------------------------7 表3-1、PGx相關之研究論文與臨床試驗案件逐年增加-----------28 表3-2、依新藥開發價值鍊分析PGx應用產生之潛在效益---------31 表3-3、傳統藥物與PGx藥物之市場性、開發模式、及經濟效益之比較------------------------------------------------------34 表4-1、依據目標應用市場分析PGx營運模式之成功關鍵---------47 表4-2、PGx產品開發效益之市場機會分析---------------------49 圖 目 錄 圖1-1、新藥開發時程長且成功率低---------------------------3 圖1-2、新藥開發各階段成本分析-----------------------------4 圖1-3、新藥研發經費逐年增加,但每年核准上市之新藥數目不增反減--------------------------------------------------------5 圖1-4、PGx應用之潛在效益是否有助於解決當前產業瓶頸-------11 圖1-5、PGx應用如何影響產業結構---------------------------11 圖1-6、本論文之研究流程----------------------------------13 圖1-7、本論文之研究架構----------------------------------14 圖2-1、五力分析模型--------------------------------------17 圖2-2、價值網之基本架構圖--------------------------------20 圖3-1、基因多型性對於PK及PD之影響------------------------28 圖3-2、PGx檢測使醫療行為趨向於個人最佳化照護-------------30 圖3-3、PGx有助於降低臨床試驗成本並改善試驗結果-----------35 圖4-1、TPMT多型性檢測協助Thiopurine藥物劑量之選擇,以降低藥害風險---------------------------------------------------44 圖4-2、依據目標應用市場分析PGx營運模式------------------46 圖4-3、Roche的價值網分析---------------------------------60 圖4-4、Affymetrix的價值網分析---------------------------63 圖4-5、ParAllele的價值網分析----------------------------65 圖5-1、PGx應用之潛在效益有助於解決當前產業瓶頸-----------70 圖5-2、PGx應用影響產業結構之推論分析---------------------71 附 錄 目 錄 附錄一、生技醫藥產業特性分析-----------------------------86 附錄二、私製檢測(”home-brew” tests)------------------88 附錄三、基因檢測(Genetic Tests)------------------------89 附錄四、中英名詞對照-------------------------------------90 | |
dc.language.iso | zh-TW | |
dc.title | 藥物基因體學對生技醫藥產業生態影響之探討 | zh_TW |
dc.title | An Explorative Study on the Impact of Pharmacogenomics on the Landscape of Biomedical Industry | en |
dc.type | Thesis | |
dc.date.schoolyear | 93-2 | |
dc.description.degree | 碩士 | |
dc.contributor.oralexamcommittee | 湯明哲,劉恆逸 | |
dc.subject.keyword | 藥物基因體學,生技醫藥產業,競合策略, | zh_TW |
dc.subject.keyword | Pharmacogenomics,Biomedical industry,Co-opetition, | en |
dc.relation.page | 94 | |
dc.rights.note | 有償授權 | |
dc.date.accepted | 2005-07-07 | |
dc.contributor.author-college | 管理學院 | zh_TW |
dc.contributor.author-dept | 國際企業學研究所 | zh_TW |
顯示於系所單位: | 國際企業學系 |
文件中的檔案:
檔案 | 大小 | 格式 | |
---|---|---|---|
ntu-94-1.pdf 目前未授權公開取用 | 1.74 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。