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請用此 Handle URI 來引用此文件: http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/22706
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dc.contributor.advisor陳鴻基(Houn-Gee Chen)
dc.contributor.authorChris H. Leeen
dc.contributor.author李玄曲zh_TW
dc.date.accessioned2021-06-08T04:25:18Z-
dc.date.copyright2010-05-22
dc.date.issued2010
dc.date.submitted2010-05-20
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dc.identifier.urihttp://tdr.lib.ntu.edu.tw/jspui/handle/123456789/22706-
dc.description.abstractTaiwan 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.provenanceMade 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.tableofcontentsTable 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.isoen
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.subjectWorld Health Organizationen
dc.subjectTraditional Chinese Medicineen
dc.subjectClustersen
dc.subjectCROen
dc.subjectCMOen
dc.subjectUS FDAen
dc.subjectBotanicalen
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.titleTaiwan’s Traditional Chinese Medicine to US FDA Botanical Drugs: A Cluster Perspectiveen
dc.typeThesis
dc.date.schoolyear98-2
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.keywordTraditional Chinese Medicine,World Health Organization,Botanical,US FDA,CMO,CRO,Clusters,en
dc.relation.page73
dc.rights.note未授權
dc.date.accepted2010-05-20
dc.contributor.author-college管理學院zh_TW
dc.contributor.author-dept商學研究所zh_TW
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