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  1. NTU Theses and Dissertations Repository
  2. 工學院
  3. 工業工程學研究所
Please use this identifier to cite or link to this item: http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/80144
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???org.dspace.app.webui.jsptag.ItemTag.dcfield???ValueLanguage
dc.contributor.advisor周雍強(Yon-Chun Chou)
dc.contributor.authorLi-Ying Chengen
dc.contributor.author鄭莉瑩zh_TW
dc.date.accessioned2022-11-23T09:28:32Z-
dc.date.available2021-08-13
dc.date.available2022-11-23T09:28:32Z-
dc.date.copyright2021-08-13
dc.date.issued2021
dc.date.submitted2021-07-05
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Retrieved from https://www.biopharm.org.tw/images/2020/Biotechnology-Industry-in-Taiwan-2020.pdf [37] 読めばわかる!オーソライズド ジェネリック(AG). Retrieved from https://www.daiichisankyo-ep.co.jp/ag/ [38] 衛生福利部. (2015). 全面完成藥廠符合PIC/S GMP,並積極推動藥品「源頭」與「運銷」管理. Retrieved from https://www.mohw.gov.tw/cp-2642-20865-1.html [39] 衛生福利部中央健康保險署. (2014). 新制健保藥價調整改革上路. Retrieved from https://www.nhi.gov.tw/News_Content.aspx?n=FC05EB85BD57C709 sms=587F1A3D9A03E2AD s=1B03BA6DD08418DE [40] 鄭景玲. (2019). 製藥工程師報到-技職新亮點、製藥大躍進. Retrieved from https://rndc.ntut.edu.tw/p/404-1037-97738.php?Lang=zh-tw [41] 篠原, 拓. (2019). オーソライズド・ジェネリックの拡大-後発薬市場の活性化は進むか? Retrieved from https://www.nli-research.co.jp/report/detail/id=61569?pno=2 site=nli [42] 醫藥產業年鑑2017. (2017). (許毓真 Ed.): 財團法人生物技術開發中心.
dc.identifier.urihttp://tdr.lib.ntu.edu.tw/jspui/handle/123456789/80144-
dc.description.abstract"過去,「授權學名藥」(Authorized Generic, AG)被視為專利藥廠削減學名藥挑戰專利意願、阻止first-filer進入市場的武器,但近年來,專利藥廠與學名藥廠的合作時有所聞,專利藥廠與學名藥廠之間的授權實例逐漸增加,專利藥廠與學名藥廠的競合變得更加多元。「授權學名藥」應可成為學名藥廠在自行以逆向工程研發藥品以外的另外一種策略選擇。 然而,台灣製藥產業中的授權學名藥並不常見,因此在以學名藥廠觀點出發的相關研究中,尚未有充分的解釋,或很少被檢視。本研究之目的,在於探討學名藥廠在何種條件下可選擇與專利藥廠策略結盟,選擇上市「授權學名藥」,並且運用設計結構矩陣(Design Structure Matrix, DSM)來改善評估流程。 本研究經整理歸納文獻後,提出可行性決策假說模型,將開發標的藥品依照技術可行性與市場可行性分類為四個象限。第一象限之藥品可視原廠品牌力效果高低,選擇「授權學名藥」策略或自行開發;第二象限之藥品應選擇「授權學名藥」策略;第三象限之藥品不予開發;第四象限的藥品則選擇自行開發。 公司在使用模型決策前,須先進行可行性評估工作。評估工作的流程順序繁雜,可先使用設計結構矩陣分析來進行流程精簡與改善後再執行。經過評估,公司可得知開發標的藥品在可行性決策模型上的最終落點,進而做出最終決策。期待此假說模型及運用DSM改善流程的方式能作為學名藥廠的未來參考,建議未來相關研究能補足此假說模型之不足,並精進流程管理上Domain Mapping Matrix (DMM)與Multi Domain Matrix(MDM)的相關應用。"zh_TW
dc.description.provenanceMade available in DSpace on 2022-11-23T09:28:32Z (GMT). No. of bitstreams: 1
U0001-3006202122454000.pdf: 1810847 bytes, checksum: b0c67662a89cc5ca7bedd771c49875b9 (MD5)
Previous issue date: 2021
en
dc.description.tableofcontents誌謝 I 中文摘要 II ABSTRACT III CONTENTS目錄 V 圖目錄 VII 表目錄 VIII CHAPTER 1 緒論 1 1.1 問題背景 1 1.2 研究目的 4 1.3 研究方法 5 1.4 論文結構 6 CHAPTER 2 文獻回顧 7 2.1 學名藥產業的重要性 7 2.2 台灣學名藥產業面臨的困難 12 2.3 現有流程改善方法-設計結構矩陣之介紹 17 2.3.1 活動型矩陣 20 2.3.2 改善耦合區塊的流程 22 2.3.3 活動型矩陣的優點與限制 22 2.4 DOMAIN MAPPING MATRIX與MULTIPLE DOMAIN MATRIX 24 CHAPTER 3 建構學名藥廠選擇策略之評估流程與模型 27 3.1 可行性決策模型 27 3.1.1 技術可行性 27 3.1.2 市場可行性 27 3.1.3 決策模型 28 3.2 運用DSM改善可行性評估流程 30 CHAPTER 4 結論 40 4.1 DSM改善流程之成果 40 4.2 專家會議驗證 42 4.3 結論 43 參考書目 44
dc.language.isozh-TW
dc.subject授權學名藥zh_TW
dc.subject設計結構矩陣zh_TW
dc.subjectAuthorized generic drugsen
dc.subjectDesign Structure Matrixen
dc.title選擇自行研發或爭取授權開發學名藥之決策流程zh_TW
dc.titleA Study on the Decision-Making Flow for Choosing Between Self-Development and Authorized Development of Generic Drugsen
dc.date.schoolyear109-2
dc.description.degree碩士
dc.contributor.oralexamcommittee洪一薰(Hsin-Tsai Liu),林文堯(Chih-Yang Tseng),林信宏
dc.subject.keyword授權學名藥,設計結構矩陣,zh_TW
dc.subject.keywordAuthorized generic drugs,Design Structure Matrix,en
dc.relation.page46
dc.identifier.doi10.6342/NTU202101221
dc.rights.note同意授權(全球公開)
dc.date.accepted2021-07-06
dc.contributor.author-college工學院zh_TW
dc.contributor.author-dept工業工程學研究所zh_TW
Appears in Collections:工業工程學研究所

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