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)