| 當期課號 | 7256 | Course Number | 7256 |
|---|---|---|---|
| 授課教師 | 王順成 | Instructor | WANG,SHUN CHENG |
| 中文課名 | 生技產品安全評估 | Course Name | Safety Evaluation Technique for Bioproducts |
| 開課單位 | 生化科技研究所碩士班一A | Department | |
| 修習別 | 選修 | Required/Elective | Elective |
| 學分數 | 3 | Credits | 3 |
| 課程目標 | 讓學生由生物安全評估之原理結合操作方法，以學習生技產品實際上市應用程序。 | Objectives | This course is designed for understanding of the principle together with the methods in the safety evaluation techniques. It prepares for developing an insight in regard to proper application of experimental results, especially on bioproducts. |
| 教材 | 自編講義,並使用電腦投影片教學動物中心進行動物實習 | Teaching Materials | handout , powerpoint and practice in animal center |
| 成績評量方式 | 期中及期末考各乙次 各佔總成績50% | Grading | middle exami. 50% final exami. 50% |
| 教師網頁 | scwang | ||
| 教學內容 | 1.總論：生技產品之開發與安全性評估之相關性2.生技產品3.生技產品功能性評估之動物模式4.生技產品安全性評估之動物模式5.生技產品之口服急毒性安全評估技術６.生技產品之皮膚急毒性安全評估技術７.生技產品之呼吸急毒性安全評估技術８.生技產品之眼及皮膚刺激安全評估技術９.生技產品之皮膚過敏安全評估技術１０.生技產品之遲發性神經毒性安全評估技術１１生技產品之安全風險評估 | Syllabus | 1.Introduction:The relationship between safety evaluation techniques and the development of bioproduct 2.The drug development and safety evaluation animal models 3. Functional evaluation of bioproduct on animal model 4.Safety evaluation animal models 5.Acute oral toxicity test 6. acute dermal toxicity test 7. Acute inhalation toxicity test 8. Acute eye and dermal irritation test 9.Acute dermal sentization test 10.Acute delayed neurotoxicity test 11.Risk assessment of bioproduct |