課程名稱 |
轉譯醫學及臨床試驗 Translational Medicine and Clinical Trials |
開課學期 |
106-2 |
授課對象 |
醫學院 腫瘤醫學研究所 |
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 |
2.0 |
全/半年 |
半年 |
必/選修 |
選修 |
上課時間 |
星期二8,9(15:30~17:20) |
上課地點 |
基醫104 |
備註 |
本課程中文授課,使用英文教科書。腫瘤所學生非醫生身份者必選。醫學校區研究所共同課程,與林滿玉合開。限醫學院基礎學科之碩博生。與林家齊、陳恆德、林君榮、俞松良、鄧哲明、沈麗娟、高純琇、徐志宏、許 駿、簡國龍合授 總人數上限:124人 |
Ceiba 課程網頁 |
http://ceiba.ntu.edu.tw/1062md_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 |
02/19From bench to bedside and from bedside to bench
02/26Pathophysiology for molecular biologists, how to cure or control disease
03/05Basic pharmacology for molecular biologists
03/12Pharmacokinetics for molecular biologists, absorption, distribution, metabolism and excretion.
03/19Drug formulation and novel drug delivery systems
03/26Preclinical development of new compounds or biologics. Chemistry, manufacture and control (CMC) and preclinical requirements for entry into human
04/09Clinical development of new drugs or biologics
04/16Regulations and international standards for drug development, GMP, GLP, GCP etc.
04/23Phase 0 and phase I clinical studies. Can the compound be used in human? Does the drug have any pharmacological effect on human?
04/30Phase II and phase III clinical studies. Is there any value for the drug to be registered?
05/07Post-marketing obligations, commitment and activities. Phase IV studies, pharmacovigilance
05/14Biostatistics 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?
05/21Non-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.
05/28Medical imaging studies to guide drug development
06/04Case study : anticancer drug development
06/11Case study : Liver cancer treatment
06/18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 |
2/27 |
From bench to bedside and from bedside to bench |
第2週 |
3/06 |
Pathophysiology for molecular biologists, how to cure or control disease |
第3週 |
3/13 |
Basic pharmacology for molecular biologists |
第4週 |
3/20 |
Pharmacokinetics for molecular biologists, absorption, distribution, metabolism and excretion |
第5週 |
3/27 |
Clinical development of new drugs or biologics |
第6週 |
4/03 |
春假停課 |
第7週 |
4/10 |
Preclinical development of new compounds or biologics. Chemistry, manufacture and control (CMC) and preclinical requirements for entry into human |
第8週 |
4/17 |
Drug formulation and novel drug delivery systems |
第9週 |
4/24 |
Commercialization of academia achievements in new drug R&D- Taiwan's strategies in regulatory science and project management |
第10週 |
5/01 |
Phase 0 and phase I clinical studies. Can the compound be used in human? Does the drug have any pharmacological effect on human? |
第11週 |
5/08 |
Phase II and phase III clinical studies. Is there any value for the drug to be registered? |
第12週 |
5/15 |
Post-marketing obligations, commitment and activities. Phase IV studies, pharmacovigilance |
第13週 |
5/22 |
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14週 |
5/29 |
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15週 |
6/05 |
Case study : Liver cancer treatment |
第16週 |
6/12 |
Final Exam |
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