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完整後設資料紀錄
DC 欄位 | 值 | 語言 |
---|---|---|
dc.contributor.advisor | 李素華 | zh_TW |
dc.contributor.advisor | Su-Hua Lee | en |
dc.contributor.author | 杜維誠 | zh_TW |
dc.contributor.author | Wei-Cheng Tu | en |
dc.date.accessioned | 2023-08-08T16:07:29Z | - |
dc.date.available | 2023-11-09 | - |
dc.date.copyright | 2023-08-08 | - |
dc.date.issued | 2023 | - |
dc.date.submitted | 2023-07-13 | - |
dc.identifier.citation | 药械组合产品研究及应用进展-中國醫療器械雜誌201203, 作者汤康丽,周俊蕾,李勇,瞿敏明,王钰婕,罗健, 上海微创医疗器械(集团)有限公司
Tertiary patenting on drug–device combination products in the United States, Reed F Beall & Aaron S Kesselheim Drug-device combination products: regulatory landscape and market growth-2015, journals, L Bayarri Generic drug device combination products: Regulatory and scientific considerations-2017, sciencedirect,Stephanie H. Choi, Yan Wang, Denise S. Conti, Sam G. Raney, Renishkumar Delvadia, Andrew A. Leboeuf, Kimberly Witzmann 美國:專利申請過程中隱瞞已知技術屬不正行為,將導致專利不可實施-2021, 惇安律師事務所, 簡哲永/王惠玲 從SmithKline Beecham Consumer Healthcare, L.P. v. Watson Pharms., Inc.案探討學名藥仿單之著作權侵-智慧財產權月刊191期- page 55 Advances in drug delivery related biosensors and medical devices-2018. Jie Shen, Diane J. Burgess UNITED THERAPEUTICS CORPORATION REPORTS FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS CENTER FOR DRUG EVALUATION AND RESEARCH 美國組合醫療產品監管體系研究與啟示-中國醫療器械雜誌2021, 作者董謙,田蒙,母瑞紅 藥械組合產品屬性界定常見問題的思考-中國醫療器械雜誌2019, 作者田佳鑫,許耘,楊曉冬,張家振,王永清,付小兵,樊瑜波 老年慢性阻塞性肺疾病病人使用吸入器之正確性及相關因素探討-2020, 高雄醫學大學護理學系碩士班論文, 作者溫宛虹 第一次使用吸入器就上手-氣喘與慢性阻塞性肺病吸入治療-台灣胸腔暨重症加護醫學會(2016,11月) Drug to Watch 2023-2023, Clarivate group Guideline on quality documentation for medicinal products when used with a medical device-July 2021, Committee for Medicinal Products for Human Use (CHMP) Guideline on the quality requirements for drug-device combinations-May 2019, Committee for Medicinal Products for Human Use (CHMP) Principles of Premarket Pathways for Combination Products Guidance for Industry and FDA Staff-Jan 2022, Food and Drug Administration 複合性藥物(含藥醫療器材)之法規管理現況-2016, 作者謝慧真,當代醫藥法規月刊 新藥臨床試驗簡介-2013, 作者/歐盈全、歐盈如;譯/王惟芬, 科學月刊 TEVA贏得FDA對EpiPen學名藥的認可https://news.gbimonthly.com/tw/article/show.php?num=23304 "CSL 787 is a nebulized human plasma-derived polyvalent immunoglobulin G (IgG) product, being developed by CSL Behring, for the prevention of chronic respiratory" https://adisinsight.springer.com/drugs/800056831 藥械合一 將成新趨勢https://www.chinatimes.com/newspapers/20150126000042-260202?chdtv FDA核准首款吸入式肺動脈高壓療法https://ibmi.taiwan-ealthcare.org/zh/news_detail.php?REFDOCTYPID=0o4dd9ctwhtyumw0&REFDOCID=0rcguq7knfa9izpe <肺動脈高壓>United Therapeutics(聯合治療)吸入性藥物專利判決出爐,Liquidia學名藥最快2024年上市http://www.genetinfo.com/international-news/item/62726.html 興櫃再添新兵》開發藥械合一模式 國邑藥品主攻肺動脈高壓https://tw.news.yahoo.com/%E8%88%88%E6%AB%83%E5%86%8D%E6%B7%BB%E6%96%B0%E5%85%B5-%E9%96%8B%E7%99%BC%E8%97%A5%E6%A2%B0%E5%90%88-%E6%A8%A1%E5%BC%8F-%E5%9C%8B%E9%82%91%E8%97%A5%E5%93%81%E4%B8%BB%E6%94%BB%E8%82%BA%E5%8B%95%E8%84%88%E9%AB%98%E5%A3%93-000116575.html 搶攻治新冠商機 健喬呼吸道用藥「布地奈德」加速海外布局https://www.chinatimes.com/realtimenews/20210628003840-260410?chdtv Drug Device Combination Product Market Is Booming Worldwide 2023-2028 | AbbVie Inc. (Allergan), Terumo Corporation, GlaxoSmithKline PLC, Novartis AG, Medtronic PLC, Abbott Laboratorieshttps://www.digitaljournal.com/pr/news/drug-device-combination-product-market-is-booming-worldwide-2023-2028-abbvie-inc-allergan-terumo-corporation-glaxosmithkline-plc-novartis-ag-medtronic-plc-abbott-laboratories 什么是药械组合产品http://www.zhengbiaoke.com/wap/service_show.aspx?id=%2081 Cost reduction strategies for emergency services: insurance role, practice changes and patients accountabilityhttps://pubmed.ncbi.nlm.nih.gov/18306043/ | - |
dc.identifier.uri | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/88062 | - |
dc.description.abstract | 現行的藥物開發流程,不管是全新藥開發或者高階學名藥,多是曠日廢時;早早從實驗室延伸出來所申請到手的專利,往往經過化學結構的確認、劑量的調配、賦形劑的搭配、適用疾病的選定以及臨床試驗及法規認證多道關卡後,最後才會走到上市許可,此時原先藥物專利保護的年限可能所剩無幾,藥物上市沒多久馬上就會面臨到巨獸學名藥公司對產品及市場的虎視眈眈。
複合式藥物(藥械合一/Combination Products)是美國FDA針對藥物、器械或者生物製劑組合而成的產品所給的名稱。此種產品除了藥物本身的療效外,亦直接搭配了與該藥物最適的遞送裝置(方式),可以提供患者最適的治療,亦可增加病患藥物依從性(Drug Compliance)、降低不良反應風險;此外,藥物與器械的專利屬兩種不同專業領域的範疇,在全球專業分工的企業經營模式下,鮮少有企業會同時具備藥物與器械豐富的專利及知識。 此篇除了介紹複合式藥物法規,亦透過案例分析複合式藥物的商業模式中,醫療器材公司如何在其產品及專利設計上適當的增加複合式藥物組合產品的在市場上的獨家銷售權,讓藥物開發公司原先認定所剩無幾的銷售年度可以延長,進而增加了醫療器材公司在藥物市場的不可取代性;又或者藥物開發公司透過老藥新用的模式配合複合式藥物法規,可以再次地以新藥的角色在市場上繼續銷售藥品,維持領先地位。 | zh_TW |
dc.description.abstract | In the current day, drug company spends a lot of time developing new drugs and specific generic drugs in different chemical structures, dose, and formulation by laboratory in the early stage. After collocation, selection of applicable diseases, clinical tr, trials and regulatory certification, it will finally reach marketing authorization. At this time, the original patent protection period of the drug may be running out, and the drug will soon face competition from generic companies.
Combination Products is the name given by the US FDA for products that combine drugs, devices, or biological agents. In addition to the curative effect of the drug itself, this product is also directly matched with the most suitable delivery device (method) for the drug, which can provide the most suitable treatment for the patient, increase the patient's drug compliance, and reduce the risk of adverse reactions; In addition, the patents of drugs and devices belong to two different professional fields. Under the business model of the global professional division of labor, few companies have rich patents and knowledge of drugs and devices at the same time. In addition to introducing the regulations on the combination of drugs and devices, this article also uses case studies to analyze how medical device companies can appropriately increase the exclusive sales rights of the combined products of durgs and devices in the market in terms of their products and patent designs in the business model of drug-device combination, so that the drug development company originally determined that the few remaining sales years can be extended, thereby increasing the irreplaceability of the medical device company in the drug market, and the company can continue to sell drugs in the market and maintain a leading position. | en |
dc.description.provenance | Submitted by admin ntu (admin@lib.ntu.edu.tw) on 2023-08-08T16:07:29Z No. of bitstreams: 0 | en |
dc.description.provenance | Made available in DSpace on 2023-08-08T16:07:29Z (GMT). No. of bitstreams: 0 | en |
dc.description.tableofcontents | 致謝 I
中文摘要 II Abstract III 圖目錄 VI 表目錄 VII 第一章 緒論 1 1.1 研究背景 1 1.2 研究動機 2 1.3 研究目的 3 1.4 研究方法及流程 4 第二章 複合式藥物介紹 5 2.1 美國複合式藥物法規 5 2.2 複合式藥物產品種類 6 2.3 知名複合式藥物產品介紹 8 2.3.1亞培XIENCE Sierra™ 8 2.3.2 Johnson & Johnson ACUVUE®Theravision® 9 2.3.3 Mylan EpiPen® 10 2.3.4 Insmed ARIKAYCE® 11 2.4 複合式藥物市場 11 2.4.1 人口老化和慢性疾病的增加 12 2.4.2 政策支持和市場需求 14 2.4.3 法規的更新 14 2.4.4 醫療保健成本的壓力 15 2.4.5 多元產品的出現、全球趨勢 16 2.5 複合式藥物SWOT分析 16 第三章 新藥開發公司與醫材公司角色 19 3.1 複合式藥物開發主導者、主要資金贊助者 19 3.2 產品開發 19 3.3 臨床試驗 20 3.4 藥證擁有者 20 3.5 專利的申請 21 3.6 個別面臨的風險 23 3.7 小結 26 第四章 以醫材公司為角度看商業模式 27 4.1 商業模式圖 27 4.2 契機 30 4.2.1 原廠高價藥物專利到期 30 4.2.2 原複合式藥物產品專利到期,更換裝置延續生命 33 4.2.3 組合產品療效更好 34 4.2.4 組合產品用藥順從性更高 37 4.2.5 老藥新用組合產品更改適應症提高價值 40 4.3 專利保護 41 4.3.1 專利分析 42 4.3.2 器械專利保護藥品模式 47 4.3.3 實際案例、 47 4.4 小結 48 第五章 研究結論與建議 49 5.1 本研究之發現 49 5.2 研究結論 49 5.3建議 50 參考文獻 52 參考網站 53 | - |
dc.language.iso | zh_TW | - |
dc.title | 複合式藥物商業模式之研究-以醫材公司為角度 | zh_TW |
dc.title | Study on Business Model of Drug Device Combination Products: From the Viewpoint of Medical Device Company | en |
dc.type | Thesis | - |
dc.date.schoolyear | 111-2 | - |
dc.description.degree | 碩士 | - |
dc.contributor.oralexamcommittee | 吳全峰;張濱璿 | zh_TW |
dc.contributor.oralexamcommittee | Chuan-Feng Wu;Pin-Hsuan Chang | en |
dc.subject.keyword | 複合式藥物,藥械合一,老藥新用,藥物依從性, | zh_TW |
dc.subject.keyword | Combination Products,Drug Compliance,drug repurposing, | en |
dc.relation.page | 53 | - |
dc.identifier.doi | 10.6342/NTU202301495 | - |
dc.rights.note | 未授權 | - |
dc.date.accepted | 2023-07-14 | - |
dc.contributor.author-college | 進修推廣學院 | - |
dc.contributor.author-dept | 生物科技管理碩士在職學位學程 | - |
顯示於系所單位: | 生物科技管理碩士在職學位學程 |
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