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課程名稱 |
生技製藥一
PHARMACEUTICAL BIOTECHNOLOGY(Ⅰ) |
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開課學期 |
96-1 |
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授課對象 |
醫學院 藥學研究所 |
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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 |
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全/半年 |
半年 |
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必/選修 |
必修 |
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上課時間 |
星期一7(14:20~15:10) |
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上課地點 |
基1203 |
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備註 |
與何蘊芳合開
總人數上限：18人 |
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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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課程概述 |
生技製藥 |
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課程目標 |
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課程要求 |
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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 |
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參考書目 |
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評量方式
(僅供參考) |
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No. |
項目 |
百分比 |
說明 |
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1. |
Written Exam |
90% |
one mid-term |
2. |
Class participation |
10% |
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週次 |
日期 |
單元主題 |
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第1週 |
9/17 |
Introduction |
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第2週 |
9/24 |
Molecular Biotechnology/Gene Expression and Its Regulation (I) Chapter 1 (CS), Chapters 2 and 3 (KM) — gene expression, specific DNA technology (sequencing, hybridization, PCR, etc.), recombinant DNA technology (cloning), introduction to expression systems (prokaryotic/eukaryotic, microbes /animal cells/plant cells) |
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第3週 |
10/01 |
Molecular Biotechnology/Gene Expression and Its Regulation (II) Chapters 1 and 6 (CS) — principles of site directed mutagenesis & applications in improving properties of proteins (protein engineering), the impact of biotechnology on drug discovery |
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第4週 |
10/08 |
Production of Biotech Compounds Chapter 3 (CS), Chapters 2, 3, and 6 (KM) — cultivation in various expression systems (prokaryotic/eukaryotic, microbes/animal cells/plant cells), downstream processing/characterization/bioanalysis (KM Ch. 6), issues to consider in production and purification processes |
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第5週 |
10/15 |
Physicochemical properties, structure and stability of peptides & proteins Chapter 2 (CS) — protein structure, protein folding, protein stability, analytical techniques |
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第6週 |
10/22 |
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7週 |
10/29 |
Patents in the Pharmaceutical Biotechnology Industry/Drug Approval in the EU and the United States Chapters 10 and 11 (KM) |
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第8週 |
11/05 |
PK/PD of Peptide and Protein Drugs/Dispensing biotechnology products Chapter 5 (CS), Chapter 8 (KM) — also includes protein binding, interspecies scaling, heterogeneity of protein therapeutics, chemical modifications, immunogenicity Chapter 18 (CS) — storage, handling, preparation, administration, outpatient/home care issues |
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第9週 |
11/12 |
Midterm Exam |
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