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題 名 | 臨床試驗藥品管理經驗分享=Experiences in Management of Investigation Products |
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作 者 | 張維漢; 陳偉立; 林佳慧; 王秀尹; | 書刊名 | 藥學雜誌 |
卷 期 | 27:1=106 2011.03[民100.03] |
頁 次 | 頁34-38 |
分類號 | 418.11 |
關鍵詞 | 臨床試驗藥品管理; 藥品優良臨床試驗準則; 藥師; Management of investigational product; Good clinical practice; Pharmacist; |
語 文 | 中文(Chinese) |
中文摘要 | 醫學研究種類繁多,其中屬藥品臨床試驗,如新藥開發、上市藥品拓展新適應症、新劑型開發以至學名藥欲證明與原開發廠療效相同,都需運用科學方式提供足以信賴之證據,方可運用於臨床上。臨床試驗除計劃主持人、研究護士、臨床研究專員外,尚須藥師參與擔任管理臨床試驗藥品的角色。 臨床試驗藥品與一般臨床藥品的管理有許多不同,本文提供某醫學中心藥師實際參與臨床試驗藥品管理之經驗,期望拋磚引玉對此類藥品管理有所迴響。 |
英文摘要 | All varieties of medical researches are required to be scientifically validated before clinical applications and clinical trials involved drug intervention also included. Examples of clinical trials involved drug intervention are new drug development, new indication and formulation explorations, and bioequivalence comparison to brand drugs. In addition to principal investigators, clinical research coordinators, and clinical research associates, pharmacists also play a vital role in the management of investigational products. In the aspect of drugs management, there are lots of difference between investigational drugs and ordinary medications. With the expectation of eliciting more responses to investigational drug management, this article provides practical experiences of pharmacists in a teaching hospital setting. |
本系統中英文摘要資訊取自各篇刊載內容。