課程名稱 |
轉譯醫學及臨床試驗 Translational Medicine and Clinical Trials |
開課學期 |
103-2 |
授課對象 |
醫學院 轉譯醫學博士學位學程 |
授課教師 |
楊志新 |
課號 |
md&ph5072 |
課程識別碼 |
420 U4700 |
班次 |
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學分 |
2 |
全/半年 |
半年 |
必/選修 |
選修 |
上課時間 |
星期二7,8(14:20~16:20) |
上課地點 |
基醫104 |
備註 |
本課程中文授課,使用英文教科書。限醫學院基礎學科碩博生及校際聯盟外校生生物相關科系博班生。本學程非MD生之必選課。與施庭芳、林家齊、陳恆德、林君榮、俞松良、鄧哲明、沈麗娟、高純琇、徐志宏、郭頌鑫、許 駿、簡國龍合開 總人數上限:124人 |
Ceiba 課程網頁 |
http://ceiba.ntu.edu.tw/1032md_ph5072_ |
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 |
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 |
03/03From bench to bedside and from bedside to bench
03/10Pathophysiology for molecular biologists, how to cure or control disease
03/17Basic pharmacology for molecular biologists
03/24Pharmacokinetics for molecular biologists, absorption, distribution, metabolism and excretion.
03/31Drug formulation and novel drug delivery systems
04/07Preclinical development of new compounds or biologics. Chemistry, manufacture and control (CMC) and preclinical requirements for entry into human
04/14Clinical development of new drugs or biologics
04/21Regulations and international standards for drug development, GMP, GLP, GCP etc.
04/28Phase 0 and phase I clinical studies. Can the compound be used in human? Does the drug have any pharmacological effect on human?
05/05Phase II and phase III clinical studies. Is there any value for the drug to be registered?
05/12Post-marketing obligations, commitment and activities. Phase IV studies, pharmacovigilance
05/19Biostatistics in clinical trials. What is the probability that the drug effect we show in the clinical trial is true? What is the effect size of the treatment?
05/26Non-interventional clinical research and development of biomarkers. Prediction or prognosis. Ethical issues to conduct a clinical research. Standardization, validation, registration and certification of the tests.
06/02Medical imaging studies to guide drug development
06/09Case study : anticancer drug development
06/16Case study : Liver cancer treatment
06/23期末考
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課程目標 |
教學目標:
本課程對象為醫學院學習基礎研究的碩博士生,主要學習目標為了解基礎醫學研究的結果如何應用到臨床及如何將基礎研究的結果開發上市。課程包括臨床醫學藥學之簡介、臨床前研究之設計、臨床試驗之設計及判讀、上市後之研究及相關轉譯醫學概念。
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課程要求 |
待補 |
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 |
參考書目 |
待補 |
評量方式 (僅供參考) |
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週次 |
日期 |
單元主題 |
第1週 |
3/3 |
本週為第一週上課。
From bench to bedside and form bedside to bench |
第2週 |
3/10 |
Pathophysiology for molecular biologists, how to cure or control disease |
第3週 |
3/17 |
Basic pharmacology for molecular biologists |
第4週 |
3/24 |
Pharmacokinetics for molecular biologists, absorption, distribution, metabolism and excretion. |
第5週 |
3/31 |
Drug formulation and novel drug delivery systems |
第6週 |
4/07 |
Preclinical development of new compounds or biologics. Chemistry, manufacture and control (CMC) and preclinical requirements for entry into human |
第7週 |
4/14 |
Clinical development of new drugs or biologics |
第8週 |
4/21 |
Regulations and international standards for drug development, GMP, GLP, GCP etc |
第9週 |
4/28 |
Phase 0 and phase I clinical studies. Can the compound be used in human? Does the drug have any pharmacological effect on human? |
第10週 |
5/05 |
Phase II and phase III clinical studies. Is there any value for the drug to be registered? |
第11週 |
5/12 |
Post-marketing obligations, commitment and activities. Phase IV studies, pharmacovigilance |
第12週 |
5/19 |
Biostatistics in clinical trials. What is the probability that the drug effect we show in the clinical trial is true? What is the effect size of the treatment? |
第13週 |
5/26 |
Non-interventional clinical research and development of biomarkers. Prediction or prognosis. Ethical issues to conduct a clinical research. Standardization, validation, registration and certification of the tests. |
第14週 |
6/02 |
DCE-MRI and PET-MR in cancer imaging |
第15週 |
6/09 |
Case study : Liver cancer treatment
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第16週 |
6/16 |
Clinical studies and translation studies of radiation oncology
- molecular targets as radiosensitizers |
第17週 |
06/23 |
期末考 |
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