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課程名稱 |
生技產品統計Ⅱ中草藥評估
STATISTICAL METHOD FOR BIOTECHMOLGY PRODUCT(Ⅱ) |
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開課學期 |
97-2 |
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授課對象 |
學程 系統生物與生物資訊學程 |
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授課教師 |
劉仁沛 |
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課號 |
Agron5048 |
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課程識別碼 |
621 U6370 |
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班次 |
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學分 |
3 |
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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 |
星期一2,3,4(9:10~12:10) |
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上課地點 |
農藝108 |
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備註 |
先修統計學
總人數上限：30人 |
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Ceiba 課程網頁 |
http://ceiba.ntu.edu.tw/972biotech-2 |
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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 |
本課程將介紹有關評估中草藥及生技產品的統計方法。首先我們將介紹中草藥及生技產品研發過程與上市的相關法規及所需之資料。然後引入統計評估的觀念-不偏性(準確度)與燮異性(精密度)。再介紹各種動物毐性試驗設計輿分析及決定NOAELS的統計方法。最後再介紹評估中草藥及生技產品之療效與安全性的各種臨床試驗設計輿分析。我們亦介紹討論試驗計畫書(Protocol)的格式與內容及個案報告表(case report form)之設計。 |
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課程目標 |
Introduction: Principles in Evaluation of Traditional Chinese Medicine and Healthy Food Products
1. Stages of Development
2. Principles for Eliminaton of Bias and Control of Varibaility
II. Animal Studies
1. Designs for Toxicological Studies
2. Analyses of Toxicity Studies: Acute, Subchronic, NOAEL
III. Clinical Trials
1. Designs for Clinical Trials: Parallel, Crossover, Factorial, and Others
2. Analyses of Clinical Trials: Continuous, Categorical, Censored Data
3. Evaluation of Efficacy and Safety
4. Methods for Equiavlence and Non-inferiority
5. Sample Size Determination
6. Use of Genomic Information: Targeted Clinical Trials
IV. Review of Current Regulations
美國FDA的Guidance on Botanical Drug Products
我國衛生署中醫藥委員會中草藥新藥臨床試驗申請須知
Good Clinical Practice and Inspection
V. Protocols and Case Report Form
VI. Oral Presentations
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課程要求 |
Homework: 35%, Midterm: 20%,
Oral Final Presentation: 35%,
Attendance: 10% |
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預期每週課後學習時數 |
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Office Hours |
每週四 08:00~08:50
每週二 08:00~08:50 備註： other time by appointment |
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指定閱讀 |
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參考書目 |
Chow, S.C., and Liu, J.P. (2004) Design and Analysis of
Clinical Trials, 2nd Edition, Wiley.
Chow, S.C. and Liu, J.P. (2008) Design and Analysis of Bioavailability and
Bioequivalence Studies, CRC/Chapman & Hall
Chow S.C., and Liu, J.P. (1998) Design and Analysis of
Animal Studies in Pharmaceutical Development, Marcel
Dekker, Inc.
美國FDA的Guidance on Botanical Drug Products
我國衛生署中醫藥委員會中草藥新藥臨床試驗申請須知 |
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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. |
期中考 |
20% |
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2. |
期末考(Final Oral Presentation) |
35% |
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3. |
隨堂測驗 |
0% |
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4. |
作業 |
35% |
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5. |
報告 |
0% |
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6. |
Attendance |
10% |
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週次 |
日期 |
單元主題 |
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第1週 |
2009/02/16 |
I.Introduction:Principles in Evaluation of Traditional Chinese Medicine and Healthy Food Products |
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第2週 |
2009/02/23 |
I-1.Stages of Development |
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第3週 |
2009/03/02 |
I-2.Principles for Eliminaton of Bias and Control of Varibaility |
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第4週 |
2009/03/09 |
I-2.Principles for Eliminaton of Bias and Control of Varibaility;
II. Animal Studies: II-1 Designs for Toxicological Studies
有可能參加台荷中草藥研討會 |
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第5週 |
2009/03/16 |
II. Animal Studies: II-1 Designs for Toxicological Studies |
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第6週 |
2009/03/23 |
II-2.Analyses of Toxicity Studies: Acute, Subchronic, NOAEL, Estimating the Maximum Recommended Starting Dose in the First Human Clinical Trials |
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第7週 |
2009/03/30 |
II-2.Analyses of Toxicity Studies: Acute, Subchronic, NOAEL, Estimating the Maximum Recommended Starting Dose in the First Human Clinical Trials; III. Clinical Trials; III-1 Designs for Clinical Trials: Parallel, Crossover, Factorial, and Others |
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第8週 |
2009/04/06 |
III-1.Designs for Clinical Trials: Parallel, Crossover, Factorial, and Others |
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第9週 |
2009/04/13 |
III-2 Analysis of Clinical Trials: Continuous, Categorical, and Censored Data |
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第10週 |
2009/04/20 |
III-2.Analyses of Clinical Trials: Continuous, Categorical, Censored Data; III-3. Evaluation of Efficacy and Safety |
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第11週 |
2009/04/27 |
III-4 Statistical Methods for Equiavlence and Non-inferiority |
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第12週 |
2009/05/04 |
III-5.Sample Size Determination and Interim Analyses |
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第13週 |
2009/05/11 |
III-6 Use of Genomic Information: Targeted Clinical Trials |
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第14週 |
2009/05/18 |
IV-1. Review of Current Regulations;
IV-2. Good Clinical Practice and Inspection
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第15週 |
2009/05/25 |
V.Protocols, Case Report Form, and Data Management |
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第16週 |
2009/06/01 |
Final Oral Presentations |
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第17週 |
2009/06/08 |
Final Oral Presentations |
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