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| DC 欄位 | 值 | 語言 |
|---|---|---|
| dc.contributor.advisor | 陳鴻基(Houn-Gee Chen) | |
| dc.contributor.author | Chris H. Lee | en |
| dc.contributor.author | 李玄曲 | zh_TW |
| dc.date.accessioned | 2021-06-08T04:25:18Z | - |
| dc.date.copyright | 2010-05-22 | |
| dc.date.issued | 2010 | |
| dc.date.submitted | 2010-05-20 | |
| dc.identifier.citation | 1. 'The Alternative Fix.' PBS. U.S. News, 6 Nov. 2003. Web. 09 Dec. 2009. <http://www.pbs.org>.
2. Bagchi, Debasis. Nutraceutical and Functional Food Regulations in the United States and Around the World. Elsevier, 2008. Print. 3. Balunas, Marcy J., and A. Douglas Kinghorn. 'Drug Discovery from Medicinal Plants.' Life Sciences 78 (2005): 431-41. Print. 4. Beyond Borders Global Biotechnology Report 2009. Rep. Ernst & Young, 2009. Print. CW0064. 5. 'Business Cluster - , the Free Encyclopedia.' Wikipedia. Web. 29 Apr. 2010. <http://www.wikipedia.org/wiki/Business_cluster>. 6. CFSAN/US FDA. Office of Nutritional Products Labeling and Dietary Supplements. Dietary Supplements: Aristolochic Acid. Print. 7. Chan, Kelvin, Kelvin Sze-Yin Leung, and Sandy Shuo Zhao. 'Harmonization of Monographic Standards Is Needed to Ensure the Quality of Chinese Medicinal Materials.' CM Journal 4.18 (2009): 1-5. Print. 8. Chen, Shaw T., Jinhui Dou, Robert Temple, Rajiv Agarwal, Kuei-Meng Wu, and Susan Walker. 'New Therapies from Old Medicines.' Nature Biotechnology 26.10 (2008): 1077-083. Print. 9. Chiang, Jong-Tsong. 'Investment & Internationalization TM CAM WM.' Chinese Herbal Medicine: Investment & Internationalization. National Taiwan University College of Management, Taipei. 11 Sept. 2009. Lecture. 10. Chin, Young-Won, Marcy J. Balunas, Hee Byung Chai, and A. Douglas Kinghorn. 'Drug Discovery From Natural Sources.' The AAPS Journal 28th ser. 8.2 (2006): 239-53. Print. 11. Chou, Kuei Tien. 'Reflexive Risk Governance in Newly Industrialized Countries.' Development and Society 38.1 (2009): 66. Print. 12. Committee on Chinese Medicine and Pharmacy. Department of Health, Executive Yuan. Web. 05 Apr. 2010. <http://www.ccmp.gov.tw>. 13. 'David M Eisenberg.' Focus Altern Complement Therapies. Web. 9 Dec. 2009. 14. The Desktop Guide to Complementary and Alternative Medicine An Evidence-Based Approach. St. Louis: Mosby, 2006. Print. 15. Drews, Jurgen. 'Drug Discovery: A Historical Perspective.' Science Magazine 17 Mar. 2000: 1960-964. Print. 16. 'Drug Administration Law of the People's Republic of China.' SFDA.gov.cn. Web. 26 Dec. 2009. 17. Eisenberg, David M., Roger B. Davis, Susan L. Ettner, Scott Appel, Sonja Wilkey, Maria L. Van Rompay, and Ronald C. Kessler. 'Trends in Alternative Medicine Use in the United States, 1990-1997: Results of a Follow-up National Survey.' JAMA 280 (1998): 1569-675. Web. 18. Eisenberg, David M., Ronald C. Kessler, Cindy Foster, Frances E. Norlock, David R. Calkins, and Thomas L. Delbanco. 'Unconventional Medicine in the United States -- Prevalence, Costs, and Patterns of Use.' The New England Journal of Medicine 328.4 (1993): 246-52. Print. 19. Ernst, Edzard, Max H. Pittler, and Barbara Wider. The Desktop Guide to Complementary and Alternative Medicine An Evidence-Based Approach. St. Louis: Mosby, 2006. Print. 20. Goldman, P. Herbal Medicines Today and the Roots of Modern Pharmacology. 2001. Print. Annals of Internal Medicine 135, pp. 594-600. 21. Innovation in Global Industries U.S. Firms Competing in a New World : Collected Studies. Washington, D.C: National Academies, 2008. Print. 22. Kaphle, Krishna, Leang-Shin Wu, Nai-Yen J. Yang, and Jen-Hsou Lin. 'Herbal Medicine Research in Taiwan.' Oxford Journals (2006): 149-55. Advanced Access Publications. Web. 11 Apr. 2010. 23. Lin, I-Hsin. 'The Development Strategy of Taiwan Traditional Medicine and Pharmacy.' 2008 CAM/TM Professional Training Program. China Medical University, Taichung. 15 Sept. 2008. Speech. 24. Liu, Annie. 'Worldwide Botanical New Drugs Industry Development & Strategy.' 2009 Botanical Market & Taiwan's Development and Strategies Conference. Taichung. 11 Nov. 2009. Lecture. 25. Liu, Yixuan, and Ming-Wei Wang. 'Botanical Drugs: Challenges and Opportunities Contribution to Linnaeus Memorial Symposium 2007.' Elsevier 82 (2008): 445-49. Sciencedirect.com. Web. 26. L-O-M(TM). Web. 21 Dec. 2009. <http://www.healtheverbiotech.com/cetacean/front/bin/ptlist.phtml?Category=147847>. 27. Nissen, Steve. 'Steven Nissen Gives Obama an Rx for FDA Reform.' Pharma-mkting.com. Pharma Marketing Network Forums. Web. 27 Nov. 2009. <http://www.forums.pharma-mkting.com/showthread.php?t=9239>. 28. 'PHY906 in Liver Cancer.' Welcome to PhytoCeutica, Inc. Web. 22 Dec. 2009. <http://www.phytoceutica.com/clinicalprogram0001.html>. 29. Porter, Michael E. 'Clusters and the New Economics of Competition.' Harvard Business Review (1998): 75-90. Web. 1 Apr. 2010. 30. Porter, Michael E. 'Clusters of Innovative Initiative.' Reading. Council on Competitiveness. Pittsburgh. 17 Apr. 2010. Monitor Company Group LP; and OntheFrontier. Web. 31. Porter, Michael E. 'The Competitive Advantage of Nations.' Harvard Business Review (1990): 71-91. Web. 1 Apr. 2010. 32. 'Public Health: Traditional Chinese Medicine.' Government Information Office. The Republic of China. Web. 25 Dec. 2009. <www.gio.gov.tw>. 33. Rovner, Sophie L. 'Hot Flashes: Still a Mystery.' Chemical & Engineering News 23 Nov. 2009: 33-35. Print. 34. Simon, Francoise, and Philip Kotler. Building Global Biobrands. New York: FreePress, 2003. Print. 35. Stange, Rainer, Robert Amhof, and Susanne Moebus. 'Complementary and Alternative Medicine: Attitudes and Patterns of Use by German Physicians in a National Survey.' Web. 9 Dec. 2009. 36. Su, Yu-Shan. Strategic Positioning of Taiwan in the Global Biotechnology Value Chain. Tech. no. National Taiwan University. Taiwan, 2007. Print. 37. Sun, Lizhe. Value Creation through Modernizing Chinese Medicine. Thesis. Massachusetts Institute of Technology, 2007. Web. 38. Switzerland. World Health Organization. WHO Medicines Strategy Countries at the Core 2004-2007. WHO, 2004. Print. Ser. 2004.5. 39. Switzerland. World Health Organization. WHO Traditional Medicine Strategy 2002?2005. Print. Ser. 2002.1. 40. Tallman, Stephen, Mark Jenkins, Nick Henry, and Steven Pinch. 'Knowledge, Clusters, and Competitive Advantage.' Academy of Management Review 29.No. 2 (2004): 258-71. Jstor. Web. 1 Apr. 2010. <http://www.jstor.org>. 41. US FDA. CDER. Guidance for Industry. Botanical Drug Products. June 04. Web. Oct. 2009. <http://www.fda.gov/cder/foi/nda/2006/021902s000TOC.html>. 42. World Health Organization. National Policy on Traditional Medicine and Regulation of Herbal Medicines Report of a Who Global Survey. Chicago: World Health Organization, 2005. Print. 43. Wu, Kuei-Meng, Hanan Ghantous, and Debra B. Birnkrant. 'Current Regulatory Toxicology Perspectives on the Development of Herbal Medicines to Prescription Drug Products in the United States.' Elsevier (2008). Print. 44. Wu, Kuei-Meng, Hanan Ghantous, and Debra B. Birnkrant. 'Food and Chemical Toxicology.' Elsevier 46 (2008): 2606-601. Print. 45. Yeh, Grace, “New Drug Development in Taiwan.” Monte Jade Science and Technology Association (West Coast) Journal 215 (2007): 8-11. Web. 46. Yang, Angela W., Garry Allan, Chun Guang Li, and Charlie Changli Xue. 'Effective Application of Knowledge Management in Evidence-based Chinese Medicine: A Case Study.' Oxford Journals 6.3 (2007): 393-98. Web. | |
| dc.identifier.uri | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/22706 | - |
| dc.description.abstract | Taiwan has many core competences in the TCM industry. Amongst the more tangible ones include clinical centers and an official committee to regulate TCM established since 1995. The intangible and equally valuable are the R&D talents, laws in favor of proprietary protection of firms, and reputation that’s developed over decades of manufacturing “Taiwan” branded quality products. By banking on these assets, Taiwan may be in a key position to develop a pipeline of botanical drugs to apply to the US FDA.
In so forth, this research demonstrates that Taiwan’s TCM industry can benefit from business clusters based on Professor Michael Porter’s argument in The Competitive Advantage of Nations, 1990, where he modeled the effect of the local business environment on competition in terms of four interrelated influences depicted as the Diamond Theory. Through his studies of the California Wine Industry, there are similarities in the vertical supply chain of the industry to that of the TCM industry, both originating from the agricultural sector. Thus it is pertinent to explore and learn from successful cases and how it may be fruitful for Taiwan’s TCM industry. In his literature, a business cluster is a geographical location where enough resources and competences are amassed and an industry has reached a critical threshold, giving it a key position in a given economic branch of activity, with a decisive sustainable competitive advantage over other places, or even world supremacy in that field . He further states that, “The most important sources of prosperity are created not inherited. Productivity does not depend on what industries a region competes in, but on how it competes. The prosperity of a region depends on the productivity of all its industries.” Where, ideally, the ultimate goal is for Taiwan to gain momentum in supplying a pipeline to the US FDA Botanical Drug Path, efficiently and by an industry cluster. | en |
| dc.description.provenance | Made available in DSpace on 2021-06-08T04:25:18Z (GMT). No. of bitstreams: 1 ntu-99-R96749011-1.pdf: 4179531 bytes, checksum: 1edd62aa083634c0301da3907e927a6f (MD5) Previous issue date: 2010 | en |
| dc.description.tableofcontents | Table of Contents
Acknowledgement i Abstract ii Key words iii Acronyms iv List of Figures vii List of Tables vii Chapter 1: Introduction 1 1.1 Historical Background 3 1.2 Defining the arena 3 1.3 WHO Promotes TCM 4 1.4 Summary of WHO’s Purpose 5 1.5 Research objective 5 Chapter 2: Literature Review and Analysis Tools 7 2.1 Philip Kotler: Consumerism Effects and the Consumer Paradox 7 2.2 Michael Porter: Clusters of Innovation Initiative 10 2.3 The California Wine Cluster v. Taiwan TCM Cluster 12 Chapter 3: Key Players in Taiwan, China, Japan, Australia, & Europe 17 3.1 Botanical Drugs Status & Motivation of Clusters 17 3.2 Taiwan’s Strategic Positioning from GMP to US FDA 20 3.3 SWOT Analysis for TAIWAN TCM 23 3.4 Taiwanese Government’s Role 30 3.3 Key Players 32 Chapter 4: Qualification Methods of TM/CAM 38 4.1 Overview 38 4.2 Systems Biology to shorten drug discovery and lower costs 40 4.3 Postgenomics opens doors for TM Drug Discovery 43 4.4 Other Modern New Drug Screening Methods 45 4.5 Case Summary: Veregen™ 47 Chapter 5: US Overview of Botanical Drugs 52 5.1 Chemical, Manufacturing, & Control (CMC) Information for Botanical Drug Products 53 5.2 INDs For Phase 1 and Phase 2 Clinical Studies Issues 55 5.3 CDER Overview for Botanical Drugs 55 5.4 General Regulatory Approaches 56 5.5 Is US FDA a path to be emulated? 57 5.6 In the Pipeline, Current Phase II’s: 58 5.8 Pathway to Botanical Drugs: Successful Singleton Drugs 59 Chapter 6: Conclusions and Recommendations 62 6.1 Future Trends and Developments: Strategic Goals for the 21st Century 64 References 66 Appendix A: Acronyms 69 Appendix B: Botanical Drug IND/NDA Process 70 Appendix C: REGULATORY APPROACHES FOR MARKETING BOTANICAL DRUG PRODUCTS 70 Appendix D: INFORMATION TO BE PROVIDED IN AN IND FOR A BOTANICAL DRUG 71 | |
| dc.language.iso | en | |
| dc.subject | 台灣 | zh_TW |
| dc.subject | 許可 | zh_TW |
| dc.subject | 藥品 | zh_TW |
| dc.subject | 群聚 | zh_TW |
| dc.subject | 植物 | zh_TW |
| dc.subject | 中草藥 | zh_TW |
| dc.subject | World Health Organization | en |
| dc.subject | Traditional Chinese Medicine | en |
| dc.subject | Clusters | en |
| dc.subject | CRO | en |
| dc.subject | CMO | en |
| dc.subject | US FDA | en |
| dc.subject | Botanical | en |
| dc.title | 台灣中草藥取得美國 FDA植物藥品許可之研究:產業群聚觀點 | zh_TW |
| dc.title | Taiwan’s Traditional Chinese Medicine to US FDA Botanical Drugs: A Cluster Perspective | en |
| dc.type | Thesis | |
| dc.date.schoolyear | 98-2 | |
| dc.description.degree | 碩士 | |
| dc.contributor.oralexamcommittee | 張 舜 德(Zhang Shun-De),游張松(Yu Chang-Sung) | |
| dc.subject.keyword | 群聚,台灣,中草藥,植物,藥品,許可, | zh_TW |
| dc.subject.keyword | Traditional Chinese Medicine,World Health Organization,Botanical,US FDA,CMO,CRO,Clusters, | en |
| dc.relation.page | 73 | |
| dc.rights.note | 未授權 | |
| dc.date.accepted | 2010-05-20 | |
| dc.contributor.author-college | 管理學院 | zh_TW |
| dc.contributor.author-dept | 商學研究所 | zh_TW |
| 顯示於系所單位: | 商學研究所 | |
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