科目名稱 生技產品統計方法(I) Statistical Methods for Biotechnolgy Products (I) – In vitro Evaluations

教學目標 To provide an introduction to the statistical principles and methods in biopharmaceutical and biotechnology products – in vitro evaluations

先修科目 Introductory Statistics

教學內容及進度
I. Evaluation for Biopharmaceutical Products
1. Principles for Evaluation of Biopharmaceutical Products
2. Review of Statistical Process Control
3. USP Specifications of Biopharmaceutical Products
Dissolution
Content Uniformity
Disintegration
Setting up and Evalution of Specifications
4. Stability Studies
Regulatory Requirements
Design - Accelerated Testing and Designs for Long-term Studies
Analysis - Fixed-effects and Random-effects Model
II. Methods for Evaluation of Performance Multiplex Diagnostic Tests
1. Overview of Biochips and Microaraay Technology
2. Issues of Biochip Products Based on Microarray Technology
3. Evaluation of Microarray Products
4. Examples of Regulatory Evaluation of Biochip Products
5. Tests Based on Quantative Measurements
6. Clinical Validation and Effectiveness

教材課本
Chow, S.C. and Liu, J.P. (劉仁沛) (1995) Statistical Design and Analysis in Pharmaceutical Science: Validation, Process Controls and Stability, Marcel Dekker
美國FDA and 我國衛生署的審查準則
美國Clinical and Laboratories Standard Institutes的準則

備註(含成績考核方式作業篇數等)
Homework: 30%, Written Report: 30%, Final Exam: 40%