課程基本資料
系所 / 年級Department/Grade-Level
藥學系碩士班 1年級
課號 / 班別Course Code
71M000104 / A
學分數Credits
2 學分
選 / 必修Elective / Required
選修(Elective)
科目中文名稱Course Title (Chinese)
前導生產
科目英文名稱Course Title (English)
Scale up
負責教師Instructor
翁豐富(Wong, Fung-Fuh)
開課期間Course Load
一學期
人數上限Enrollment Max.
70 人
已選人數Enrollment Taken
2 人
抽籤自動遞補等候人數Number of the waiting list after ballot
0 人
備註Memo
丙組選修(藥物化學)
可選學制 (availability)
大學部
不可選
二技部
不可選
碩士班
1年級 至4年級
博士班
不可選

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教學綱要
課程概述Course Description
教材內容包含實驗室有機藥物合成與放大製程之差異,適化之工廠放大製程及理論,實際cGMP製藥之運作模式(藥物製造與分析檢驗及包材考量),製程放大之安全考量及人員環安等相關議題。
教學目標Course Objectives
將有機藥物合成之概念,引進放大製程理論,將結合藥廠實務及cGMP製藥之運實際作模式,使學生在藥物合成設計時,能考量未來製程放大及人員環安等相關注意事項。 The objective of this class introduce the concept of process scale-up into the medical organic synthesis. To make students understand the actual cGMP system in the API pharmaceutical factory. And causes the student can consider in the future the system regulation enlargement and the personnel surrounds and so on peacefully the related matters needing attention.when the medicine synthesis design.
先修科目Prerequisites
有機化學 Organic Chemistry
教學方式Teaching Methods
案例或故事討論 Case study or event discussion 講課 Lecturing 影片欣賞與討論 Movie review and discussions
評量方式Assessment
期中筆試 Midterm exam 期末筆試 Final exam 期中報告 Midterm report 期末報告 Final report 出席狀況 Class attendance
報告成績(20%)、小考(20%)及期中、期末考(各30%)。
參考書目Reference
1. Anderson, N. G. In Practical Process Research and Development; Academic press: New York, 2000. 2. Cybulski, A.; Moulijn, J.A.; M.M. Sharma, M.M. Sharma, Sheldon R.A. In Fine chemicals manufacture: technology and engineering; Elseriver Science D. V., 2001. 3. Takuji, H. In Innovation in the Pharmaceutical Industry: The process of Drug Discovery and development; Edward Elgar Publishing Limited: Cheltenham, UK, 2003.
教學進度Course Schedule
2016/09/12 Evolution of cGMP Regulations on API (Active Pharmaceutical Ingredients) Evolution of cGMP Regulations on API (Active Pharmaceutical Ingredients) 翁豐富(Wong, Fung-Fuh)
2016/09/19 Introduction of Pharmaceutical Business Introduction of Pharmaceutical Business 翁豐富(Wong, Fung-Fuh)
2016/09/26 New Drug Discovery and Development New Drug Discovery and Development 翁豐富(Wong, Fung-Fuh)
2016/10/03 Analysis and Control of API Analysis and Control of API 翁豐富(Wong, Fung-Fuh)
2016/10/10 Materials Management Materials Management 翁豐富(Wong, Fung-Fuh)
2016/10/17 Approach to Process Development (I) Approach to Process Development (I) 翁豐富(Wong, Fung-Fuh)
2016/10/24 Approach to Process Development (II) Approach to Process Development (II) 翁豐富(Wong, Fung-Fuh)
2016/10/31 Route Selection Route Selection 翁豐富(Wong, Fung-Fuh)
2016/11/07 Reagent Selection Reagent Selection 翁豐富(Wong, Fung-Fuh)
2016/11/14 期中考 mild Exam. 翁豐富(Wong, Fung-Fuh)
2016/11/21 Solvent Selection Solvent Selection 翁豐富(Wong, Fung-Fuh)
2016/11/28 Running the Reaction Running the Reaction 翁豐富(Wong, Fung-Fuh)
2016/12/05 Effects of Water Effects of Water 翁豐富(Wong, Fung-Fuh)
2016/12/12 In-process Controls In-process Controls 翁豐富(Wong, Fung-Fuh)
2016/12/19 Optimizing the reaction by Minimizing Impurities Optimizing the reaction by Minimizing Impurities 翁豐富(Wong, Fung-Fuh)
2016/12/26 Optimizing catalytic reactions Optimizing catalytic reactions 翁豐富(Wong, Fung-Fuh)
2017/01/02 Work-up Work-up 翁豐富(Wong, Fung-Fuh)
2017/01/09 期末考 Final Exam. 翁豐富(Wong, Fung-Fuh)