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課程名稱 |
生技製藥一
Pharmaceutical Biotechnology (Ⅰ) |
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開課學期 |
105-2 |
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授課對象 |
醫學院 藥學系 |
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授課教師 |
孔繁璐 |
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課號 |
PHARM5006 |
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課程識別碼 |
423 U0530 |
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班次 |
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學分 |
1.0 |
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全/半年 |
半年 |
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必/選修 |
選修 |
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上課時間 |
星期五8(15:30~16:20) |
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上課地點 |
水森316 |
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備註 |
總人數上限：20人 |
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Ceiba 課程網頁 |
http://ceiba.ntu.edu.tw/1052PHARM5006_ |
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課程簡介影片 |
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核心能力關聯 |
核心能力與課程規劃關聯圖 |
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課程大綱
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為確保您我的權利,請尊重智慧財產權及不得非法影印
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課程概述 |
This is the first part of a half-year course aimed to introduce students to various biotechnology-related techniques and their applications in the discovering and manufacturing of biopharmaceuticals as well as biomedical research. The course begins with a general introduction to the physicochemical characteristics of proteins and the basics in protein production and manufacturing. Since the production, downstream processing, and characterization of biopharmaceuticals are in many aspects very different from conventional small molecular therapeutics, issues relevant to the handling and delivering of those products are also highlighted (Pharm 5006). Finally, several approved and potential biopharmaceuticals are discussed (Pharm 5007). One hour of lecture per week. |
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課程目標 |
To introduce (Pharmacy) students to various biotechnology-related techniques and their applications in the discovering and manufacturing of biopharmaceuticals as well as biomedical research |
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課程要求 |
Biochemistry or consent of instructor |
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預期每週課後學習時數 |
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Office Hours |
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指定閱讀 |
待補 |
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參考書目 |
1. (CS) D. J.A. Crommelin, R.D. Sindelar (2002), Pharmaceutical
Biotechnology – An Introduction for Pharmacists and Pharmaceutical
Scientists, Hardwood Academic Publishers (or newer version)
2. (KM) O. Kayser, R.H. Muller (2004), Pharmaceutical Biotechnology – Drug
Discovery and Clinical Applications, Wiley-VCH
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評量方式
(僅供參考) |
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週次 |
日期 |
單元主題 |
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第1週 |
2/24 |
Introduction |
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第2週 |
3/3 |
Molecular Biotechnology/Gene Expression and Its Regulation (I) 講義已更新
Chapter 1 (CS), Chapters 2 and 3 (KM) |
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第3週 |
3/10 |
Molecular Biotechnology/Gene Expression and Its Regulation (II) 講義已更新
Chapters 1 and 6 (CS) |
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第4週 |
3/17 |
Production of Biotech Compounds (I)
Chapter 3 (CS), Chapters 2, 3, and 6 (KM) |
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第5週 |
3/24 |
Production of Biotech Compounds (II)
Chapter 3 (CS), Chapters 2, 3, and 6 (KM) |
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第6週 |
3/31 |
Physicochemical properties, structure and stability of peptides & proteins (I)
Chapter 2 (CS), Chapter 6 (KM) |
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第7週 |
4/7 |
Physicochemical properties, structure and stability of peptides & proteins (II)
Chapter 2 (CS), Chapter 6 (KM) |
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第8週 |
4/14 |
Formulation of Biotech Products, including Biopharmaceutical Considerations
Chapter 4 (CS), Chapter 9 (KM) – microbiological considerations, excipients, shelf life, delivery (routes of administration and absorption enhancement, rate controlled and target site specific delivery) |
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第9週 |
4/21 |
期中考週 |
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第10週 |
4/28 |
Patents in the Pharmaceutical Biotechnology Industry (I)
Chapter 10 (KM) |
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第11週 |
5/5 |
Patents in the Pharmaceutical Biotechnology Industry (II)
Chapter 10 (KM) |
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第12週 |
5/12 |
停課一次
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第13週 |
5/19 |
Drug Approval in the EU and the United States (I)
Chapter 11 (KM) |
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第14週 |
5/26 |
Drug Approval in the EU and the United States (II) Chapter 11 (KM)
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/biosimilars/ |
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第15週 |
6/2 |
Hybridoma Technology & Applications in the Production of Monoclonal Antibodies (I)
Chapter 13 (CS) |
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第16週 |
6/9 |
Hybridoma Technology & Applications in the Production of Monoclonal Antibodies (II)
Chapter 13 (CS) |
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第17週 |
6/16 |
Development of xxx 作業繳交期限: 6/26/2017 3:00 am |
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第18週 |
6/23 |
期末考週 |
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