請用此 Handle URI 來引用此文件:
http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/80303完整後設資料紀錄
| DC 欄位 | 值 | 語言 |
|---|---|---|
| dc.contributor.advisor | 王俊傑(Chun-Chieh Wang) | |
| dc.contributor.author | Huei-Yu Tu | en |
| dc.contributor.author | 杜惠于 | zh_TW |
| dc.date.accessioned | 2022-11-24T03:04:07Z | - |
| dc.date.available | 2021-11-19 | |
| dc.date.available | 2022-11-24T03:04:07Z | - |
| dc.date.copyright | 2021-11-19 | |
| dc.date.issued | 2021 | |
| dc.date.submitted | 2021-06-28 | |
| dc.identifier.citation | 吳東哲、鄒昀廷(2019)。何謂藥品專利連結?。民109年5月9日,取自https://www.wispro.com/tw/2019/04/22/patent-linkage/。 李彥錚(2008)。「中型企業」與「微、小型企業」評分模型之區隔。金融聯合徵信雙月刊,3:9-13。 理律法律事務所(2014)。美國專利連結與橘皮書登錄制度研究。經濟部智慧財產局103年度委託研究報告(編號:N07469M04019104155-1)。台北市:經濟部。 陳蔚奇(2010)。論美國專利連結制度於我國實行之妥適性。國立交通大學,新竹市。 劉玳縈(2019)。新藥開發創新組織模式Chours之探討。民109年4月10日,取自:https://portal.stpi.narl.org.tw/index/article/10530。 潘家涓、黃芝穎(2014)。生技製藥產業之併購趨勢與未來發展。民109年4月10日,取自:https://www2.deloitte.com/tw/tc/pages/life-sciences-and-health care/articles/newsletter-11-16.html。 謝愷、陳恆德、葉嘉新(2015)。藥物開發評估利器:目標產品概況簡介。民109年4月10日,取自:http://scitechreports.blogspot.com/2015/12/blog-post _30.html。 游佩芬(2020)。製藥產業觀測:回顧2019、展望2020(一)。民109年3月13日,取自:https://ieknet.iek.org.tw/iekrpt/rpt_more.aspx?actiontype=rpt indu _idno=6 domain=76 rpt_idno=569985838 Ahuja, G. Lampert, C. M. (2001). Entrepreneurship in the Large Corporation: a Longitudinal Study of How Established Firms Create Breakthrough Inventions. Strategic Management Journal, 22(6-7), 521-543. Angell, M. (2005). The Truth About the Drug Companies: How They Deceive Us and What to Do About It. New York City: Random House Trade. Arnold, D. G. Troyer, J. L. (2016). Does Increased Spending on Pharmaceutical Marketing Inhibit Pioneering Innovation. Journal of Health Politics, Policy and Law, 41(2), 157-179. Artz, K. W., Norman P. M., Hatfield, D. E., Cardinal, L. B. (2010). A Longitudinal Study of the Impact of R D, Patents, and Product Innovation on Firm Performance. Journal of Product Innovation Management, 27(5), 725-740. Caprino, L. Russo, P. (2006). Developing a Paradigm of Drug Innovation: An Evaluation Algorithm. Drug discovery today, 11(21-22), 999-1006. Chandy, K. Tellis, G. J. (1998). Organizing for Radical Product Innovation: The Overlooked Role of Willingness to Cannibalize. Journal of Marketing Research, 35(4), 474-487. Christensen, C. M. Raynor, M. E. (2003). Why hard-nosed executives should care about management theory. Harvard business review, 1-10. Coccia, M. (2017). Sources of Technological Innovation: Radical and Incremental Innovation Problem-Driven to Support Competitive Advantage of Firms. Technology Analysis Strategic Management, 29(9), 1048-1061. Cohen, F. J. (2005). Macro trends in pharmaceutical innovation. Nature Reviews Drug Discovery, 4, 78-84. Dewar, R. D. Dutton, J. E. (1986). The Adoption of Radical and Incremental Innovations: An Empirical Analysis. Management Science, 32(11), 1371-1520. Du, J., Li, P., Guo, Q., Tang, X. (2019). Measuring the Knowledge Translation and Convergence in Pharmaceutical Innovation by Funding-Science-Technology- Innovation Linkages Analysis. Journal of Informetrics, 13(1), 132-148. DiMasi, J. A. (2002). The Value of Improving the Productivity of the Drug Development Process. Pharmaco Economics, 20, 1-10. Dubey, J. Dubey, R. (2010). Pharmaceutical Innovation and Generic Challenge: Recent Trends and Causal Factors. International Journal of Pharmaceutical and Healthcare Marketing, 4(2), 175-190. Ernst, H. Fischer, M. (2014). Integrating the R D and Patent Functions: Implications for New Product Performance. Journal of Product Innovation Management, 31(1), 118-132. Ernst, H. (2003). Patent Information for Strategic Technology Management. World Patent Information, 25(3), 233-242. Freeman, C. Soete, L. (1997). The economics of industrial innovation. Oxfordshire: Taylor Francis. Gittelman, M. Kogut, B. (2003). Does Good Science Lead to Valuable Knowledge? Biotechnology Firms and the Evolutionary Logic of Citation Patterns. Management Science, 49(4), V-582. Griliches, Z. (1998). R D and Productivity: The Econometric Evidence. The University of Chicago Press. Grootendorst, P., Hollis, A., Levine, D. K., Pogge, T., Edwards, A. M. (2010). New Approaches to Rewarding Pharmaceutical Innovation. Canadian Medical Association Journal, 183(6), 681-685. Hamel, G. (1998). Opinion: Strategy Innovation and the Quest for Value. Sloan Management Review, 7-14. Hill, H. H. (2005). The Orange Book. Nature Reviews Drug Discovery, 4, 621. Hoshino, T., Banerjee, S., Cole, J. B., Itoh, M., Yatagai, T. (2011). Shape Analysis of Wavelength-Insensitive Grating in the Resonance Domain. Optics Communications, 284(10-11), 2466-2472. Huang, M. C., Fang, S. C., Chang, S. C. (2011). Tracking R D Behavior: Bibliometric Analysis of Drug Patents in the Orange Book. Scientometrics, 88, 805-818. Kesselheim, A. S. (2013). Defining “Innovativeness” in Drug Development: A Systematic Review. Clinical Pharmacology and Therapeutics, 94(3), 336-348. Keyhani, S., Wang, S., Hebert, P., Carpenter, D., Anderson, G. (2009). US Pharmaceutical Innovation in an International Context. American Journal of Public Health, 100(6), 1075-1080. Kiran, S. Kulkarni, M. (2018). Secondary Patents in the Pharmaceutical Industry: Missing the Wood for the Trees. Expert Opinion on Therapeutic Patents, 28(3), 241-250. Lichtenberg, F. R. (2005). The Impact of New Drug Launches on Longevity: Evidence from Longitudinal, Disease-Level Data from 52 Countries, 1982–2001. International Journal of Health Care Finance and Economics, 5, 47-73. Lipsky, M. S. Sharp, L. K. (2001). From idea to market: the drug approval process. The Journal of the American Board of Family Practice, 14(5), 362-367. Macke, T. M. Liang, B. A. (2012). Patent and Exclusivity Status of Essential Medicines for Non-Communicable Disease. PLOS ONE, 7(11), e51022. Mullard, A. (2020). 2019 FDA drug approvals. Nature Reviews Drug Discovery, 19, 79-84. Munos, B. (2009). Lessons from 60 Years of Pharmaceutical Innovation. Nature Reviews Drug Discovery, 8, 959-968. Munos, B. H. Chin, W.W. (2011). How to Revive Breakthrough Innovation in the Pharmaceutical Industry. Science Translational Medicine, 3(89), 16. Nerkar, A. (2003). Old Is Gold? The Value of Temporal Exploration in the Creation of New Knowledge. Management Science, 49(2), V-253. Paul, S. M., Mytelka, D. S., Dunwiddie, C. T., Persinger, C. C., Munos, B. H., Lindborg, S. R., Schacht, A. L. (2010). How to Improve R D Productivity: the Pharmaceutical Industry's Grand Challenge. Nature Reviews Drug Discovery, 9, 203-214. Prentis, R. A., Lis, Y. Walker, S. R. (1998). Pharmaceutical Innovation by the Seven UK‐Owned Pharmaceutical Companies (1964‐1985). British Journal of Clinical Pharmacology, 25(3), 387-396. Preskorn, S. H. (2000). The Stages of Drug Development and the Human Genome Project: Drug Discovery, Journal of Psychiatric Practice, 6(6), 341-344. Püntmann, I., Schmacke, N., Melander, A., Lindberg, G. Mühlbauer, B. (2010). EVITA: A Tool for the Early EValuation of Pharmaceutical Innovations with Regard to Therapeutic Advantage. BMC Clinical Pharmacology, 10(5). Roberts, R. (1998). Managing Innovation: The Pursuit of Competitive Advantage and the Design of Innovation Intense Environments. Research policy, 27(2), 159-175. Schnittker, J. Karandinos, G. (2010). Methuselah's Medicine: Pharmaceutical Innovation and Mortality in the United States, 1960–2000. Social Science Medicine, 70(7), 961-968. Schoenmakers, W. Duysters, G. (2010). The Technological Origins of Radical Inventions. Research Policy, 39(8), 1051-1059. Sorescu, A. B., Chand, R. K., Prabhu, J. C. (2003). Sources and Financial Consequences of Radical Innovation: Insights from Pharmaceuticals. Journal of Marketing, 67(4), 82-102. Sternitzke, C. (2010). Knowledge Sources, Patent Protection, and Commercialization of Pharmaceutical Innovations. Research Policy, 39(6), 810-821. U.S. GAO (2006). New Drug Development: Science, Business, Regulatory, and Intellectual Property Issues Cited as Hampering Drug Development Efforts. Report to Congressional Requesters (GAO-07-49). United States Government Accountability Office. https://www.gao.gov/products/GAO-07-49 Verhoeven, D., Bakker, J., Veugelers, R. (2016). Measuring Technological Novelty with Patent-Based Indicators. Research Policy, 45(3), 707-723. Yamanaka, T. Kano, S. (2016). Patent Term Extension Systems Differentiate Japanese and US Drug Lifecycle Management. Drug Discovery Today, 21(1), 111-117. Zannou, E. A., Li, P., Tong, W. Q. (2009). Chapter 40 - Product Lifecycle Management (LCM). Developing Solid Oral Dosage Forms, 911-921. USA Food and Drug Administration. (2020). Exclusivity and Generic Drugs:What Does It Mean? Retrieved from: https://www.fda.gov/files/drugs/published/Excl usivity-and-Generic-Drugs--What-Does-It-Mean-.pdf USA Food and Drug Administration. (2019). New Molecular Entity (NME) Drug and New Biologic Approvals. Retrieved from: https://www.fda.gov/drugs/nda-and- bla-approvals/new-molecular-entity-nme-drug-and-new-biologic-approvals USA Food and Drug Administration. (2020). Abbreviated New Drug Application (ANDA). Retrieved from: https://www.fda.gov/drugs/types-applications/abbrev iated-new-drug-application-anda USA Food and Drug Administration. (2020). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from: https://ww w.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book USA Food and Drug Administration. (2018). Priority Review. Retrieved from: https:// www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priorit NYSE. (2020). The NYSE Listed Company Network. Retrieved from: https://www. nyse.com/network National Bureau of Economic Research. (2014). Drugs@FDA Data - FDA Approved Drug Products Data. Retrieved from: https://data.nber.org/data/drugs-at-fda.html | |
| dc.identifier.uri | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/80303 | - |
| dc.description.abstract | 新藥研發是製藥公司維持競爭力至關重要的一環,為全面性的了解製藥公司的創新競爭力,本研究同時觀察製藥公司提交至美國FDA的新藥申請資料與橘皮書中的專利連結進行分析。本文首先以新藥申請時製藥公司所提供的藥品治療效果和化學成分將新藥分成漸進式創新、技術突破、市場突破與激進式創新四種創新類型,接著透過製藥公司藥品的藥證及其專利連結資料,探討製藥公司不同創新類型藥品的藥證及其專利連結表現。在藥證方面,研究結果指出無論是何種創新類型,大型企業均有較為突出的表現,而在四種創新類型中,大型企業和中小企業擁有的藥證數差異最大的是漸進式創新,顯示大型企業仰賴漸進式創新的藥證以維持創新研發資本;而在專利方面,本文發現無論是何種創新類型的藥品,製藥公司均會積極地申請專利,以保護製藥公司的創新研發成果。最後,本文研究結果亦指出漸進式創新與市場突破的藥整表現與製藥公司營業額顯著相關,若製藥公司擁有越多的漸進式創新與市場突破式創新藥證,且其藥證所剩之獨賣期越長,將顯著且正向地影響製藥公司的營業額。 | zh_TW |
| dc.description.provenance | Made available in DSpace on 2022-11-24T03:04:07Z (GMT). No. of bitstreams: 1 U0001-2606202100240300.pdf: 2703356 bytes, checksum: 56d8ea2aa4d2eedc731e205038607275 (MD5) Previous issue date: 2021 | en |
| dc.description.tableofcontents | 誌謝 i 中文摘要 ii 英文摘要 iii 第一章 緒論 1 第一節、 研究背景 1 第二節、 研究動機 3 第三節、 研究目的 6 第二章 文獻回顧 9 第一節、 製藥業的藥品研發 9 第二節、 藥品的專利保護制度 16 第三節、 藥品資訊與藥品創新 22 第三章 研究方法 31 第一節、 資料來源與樣本 31 第二節、 以藥證資訊衡量製藥公司藥品創新表現 38 第三節、 以藥證連結之專利衡量製藥公司藥品創新表現 43 第四章 研究結果 45 第一節、 以藥證資訊衡量製藥公司藥品創新的表現 45 第二節、 以藥證連結之專利衡量製藥公司藥品創新表現 53 第三節、 製藥公司藥品創新表現與營業額的連結 61 第四節、 綜合評比製藥公司的藥品創新競爭力 66 第五章 結論與建議 71 第一節、 結論 71 第二節、 研究建議 72 第三節、 研究限制 73 參考文獻 74 | |
| dc.language.iso | zh-TW | |
| dc.subject | 橘皮書 | zh_TW |
| dc.subject | 藥品創新 | zh_TW |
| dc.subject | 新藥申請 | zh_TW |
| dc.subject | 專利連結 | zh_TW |
| dc.subject | Drug Innovation | en |
| dc.subject | New Drug Application | en |
| dc.subject | Patent Linkage | en |
| dc.subject | Orange Book | en |
| dc.title | 製藥公司的藥品創新競爭力:以美國FDA藥證及其連結之專利進行分析 | zh_TW |
| dc.title | Drug Innovation Competitiveness in Pharmaceutical Companies: An Analysis of Approved Drugs and Patent Linkage in U.S. FDA | en |
| dc.date.schoolyear | 109-2 | |
| dc.description.degree | 碩士 | |
| dc.contributor.oralexamcommittee | 薛招治(Hsin-Tsai Liu),董蕙茹(Chih-Yang Tseng) | |
| dc.subject.keyword | 藥品創新,新藥申請,專利連結,橘皮書, | zh_TW |
| dc.subject.keyword | Drug Innovation,New Drug Application,Patent Linkage,Orange Book, | en |
| dc.relation.page | 80 | |
| dc.identifier.doi | 10.6342/NTU202101143 | |
| dc.rights.note | 同意授權(限校園內公開) | |
| dc.date.accepted | 2021-06-29 | |
| dc.contributor.author-college | 生物資源暨農學院 | zh_TW |
| dc.contributor.author-dept | 生物產業傳播暨發展學研究所 | zh_TW |
| 顯示於系所單位: | 生物產業傳播暨發展學系 | |
文件中的檔案:
| 檔案 | 大小 | 格式 | |
|---|---|---|---|
| U0001-2606202100240300.pdf 授權僅限NTU校內IP使用(校園外請利用VPN校外連線服務) | 2.64 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。
