頁籤選單縮合
題名 | 美國醫院藥局的研究用藥服務=The Investigational Drug Service in American Hospital Pharmacy |
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作者 | 黃志偉; 王筱萍; 秦亞惠; 陳智德; | 書刊名 | 藥學雜誌 |
卷期 | 29:1=114 2013.03[民102.03] |
頁次 | 頁133-137 |
分類號 | 418.11 |
關鍵詞 | 藥品臨床試驗; 研究用藥服務; Investigational drug service; Good clinical practice; Institution Review Boards; |
語文 | 中文(Chinese) |
中文摘要 | 世界各地的醫療機構皆不斷地參與新藥研發工作,而在美國藥師已於臨床試驗藥品的管理上扮演著重要角色。本文以俄亥俄州立大學醫學中心為例,從研究人員的組成、藥品優良臨床試驗規範、臨床試驗計劃書審核與試驗開始前的準備,及臨床試驗計劃的執行幾方面,介紹美國醫院藥局所提供的研究用藥服務,以期台灣藥師能對臨床試驗具備基本概念,進而建構符合自己醫院需求的研究用藥服務。 |
英文摘要 | Research to develop new agents is occurring in health system practice settings throughout the world. Pharmacists have played a pivotal role in the management of drugs used in the conduct of clinical research in United States. Taking Ohio State University Medical Center as an example, we introduce the investigational drug service settings in United States through several aspects, such as components of study personnel, Good Clinical Practice, review of clinical trial protocol and preparations before trial opened, and implementation of clinical trial. We hope that pharmacists in Taiwan could get general concepts about clinical trials and further develop a structure with procedures specific to its own needs and organization. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。