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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 |
94-2 |
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授課對象 |
生物資源暨農學院 農藝學系 |
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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 |
621EU6370 |
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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 |
星期二2,3,4(9:10~12:10) |
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上課地點 |
農藝108 |
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備註 |
先修統計學本課程以英語授課。
限學士班三年級以上
總人數上限：60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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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 |
In vivo Statistical Evaluations for Chinese Medicine(中草藥) and Botanical Drug Products(植物藥品) |
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課程目標 |
To provide an introduction to the statistical principles and methods in biopharmaceutical and biotechnology products — In vivo Evaluations for Chinese Medicine and Botanical Drug Products. |
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課程要求 |
I. Introduction: Principles in Evaluatiion of Traditional Chinese Medicine
II. In Vivo Evaluation
1. Stages of Development
2. Principles for Eliminaton of Bias and Control of Varibaility
2. Study Designs: Parallel, Crossover, Factorial, Group Sequential
3. Types of Studies: Multicenter, Superiority, Non-inferiority
III. Methods of Analyses
1. Continuous, Categorical, and Censored Data
2. Methods for Equiavlence and Non-inferiority
3. Sample Size Determination
4. Interim Analysis
5. Issues: Analysis Datasets, Missing Values, Multiplicity,
6. Ues of Genomic Information: Targeted Clinical Trials and Drug and Diagnostic Co-Development
IV. Data Management
1.Case Report Forms and Research Information System
V. Field Trips to CDE or to CCMP or to a CRO(being arranged)
VI. Oral Presentations
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預期每週課後學習時數 |
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Office Hours |
每週一 08:00~09:00 |
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指定閱讀 |
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參考書目 |
1. Chow, S.C., and Liu, J.P. (2004) Design and Analysis of Clinical Trials, 2nd Edition, Wiley.
2. Chow S.C., and Liu, J.P. (2000) Design and Analysis of Bioavailability and Bioequivalence Studies, 2nd Edition, Marcel Dekker, Inc.
3. Taiwan and US FDA Registration Laws and Guidelines for Approval of Tradtional Chinese Medicine
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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 |
25% |
Written Midterm |
2. |
期末考 |
30% |
Written Final Exam |
3. |
作業 |
20% |
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4. |
Oral 報告 |
25% |
Oral Presentation |
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週次 |
日期 |
單元主題 |
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第1週 |
2/21 |
1. Introduction: Principles in Evaluatiion of Traditional Chinese Medicine
2. Stages of Development
3. Principles for Eliminaton of Bias and Control of Varibaility |
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第2週 |
2/28 |
Holiday
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第3週 |
3/07 |
1. Parellel Design
2. Crossover Design
3. Factorial Design
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第4週 |
3/14 |
1. Phase I and II Designs |
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第5週 |
3/21 |
1. Multicenter Studies
2. Superiority and Non-inferiority Studies |
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第6週 |
3/28 |
1. Cluster Randomization Studies
2. Group Sequential Designs |
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第7週 |
4/04 |
Spring Break |
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第8週 |
4/11 |
1. Field Trip to Committee on Chinese Medicine and Pharmacy (TBA) |
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第9週 |
4/18 |
1. Type of Data
2. Statistical Methods for Continuous Data
2. Statistical Methods for Categorical Data
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第10週 |
4/25 |
1. Statistical Methods for Categorical Data
2. Statistical Methods for Censored Data
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第11週 |
5/02 |
1. Interim Analysis
2. Sample Size Determination |
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第12週 |
5/09 |
1. Issues in Analysis: Analysis Set, Missing Values, Multiplicity |
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第13週 |
5/16 |
1. Special Topic I: Combination Products |
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第14週 |
5/23 |
1. Special Topic II: Bridging Studies
2. Special Topic III: Vacine Studies |
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第15週 |
5/30 |
1. Data Management: Case Report Form and Research Infomration System |
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第16週 |
6/06 |
1. Field Trip to CRO (TBA) |
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第17週 |
6/13 |
1. Oral Presentations |
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第18週 |
6/20 |
1. Oral Presentations |
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