生物科技與製藥產業學
New drug development and biopharmaceutical industry
學期
111-2
學分
2
學分
當期課號
130601
永久課號
MDTM30021
開課單位
傳統醫藥研究所
授課教師
莊其穆、藍耿立
校區
陽明
類別
選修
上課時間表
| 節 | 週四 |
|---|---|
1 08:00–08:50 | 生物科技與製藥產業學 YR103 2 節連堂 |
2 09:00–09:50 |
* 根據陽明交大上課時間表所列
週次計畫
| 週次 | 主題 |
|---|---|
| 第 1 週 | Introduction |
| 第 2 週 | From bench to bedside (I)From bench to bedside (I) |
| 第 3 週 | From bench to bedside (II)From bench to bedside (II) |
| 第 4 週 | The current status of new drug development |
| 第 5 週 | Early discovery processes of drug development |
| 第 6 週 | The investigational new drug (IND) application |
| 第 7 週 | Design and statistical issues for phase I trialPatent application and maintenance |
| 第 8 週 | 校際活動周放假 |
| 第 9 週 | Patent application and maintenance (I)Design and statistical issues for phase I trial |
| 第 10 週 | Design and statistical issues for phase II trialPress release and investor relationship |
| 第 11 週 | Patent application and maintenance (II)Design and statistical issues for phase II trial |
| 第 12 週 | Design and statistical issues for phase III trialPortfolio evaluation in biotech |
| 第 13 週 | Press release and investor relationshipDesign and statistical issues for phase III trial |
| 第 14 週 | Portfolio evaluation in biotechCase studies of new startup biotech companies |
| 第 15 週 | Case studies of new startup biotech companiesRegulatory aspects of drug development |
| 第 16 週 | Regulatory aspects of drug developmentMerger and acquisition in biotech/pharm industry |
| 第 17 週 | Merger and acquisition in biotech/pharm industryCase study and report (I) |
| 第 18 週 | Case study and report (I)Case study and report (II) |
教科書
教科書名: (1) Medical Biochemistry and Biotechnology: by Dr. Amanullah Mohammed (Sep 28, 2012) (2) Nature Review of Drug Discovery (3) Bioentrepreneur (Nature Biotechnology's portal dedicated to scientists interested in commercializing their research)