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題名 | 小兒用藥之臨床試驗基本概念=Basic Concepts of Clinical Trials in Pediatric Populations |
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作者 | 黃志偉; 王筱萍; 秦亞惠; 黃旭山; | 書刊名 | 藥學雜誌 |
卷期 | 29:2=115 2013.06[民102.06] |
頁次 | 頁106-109 |
分類號 | 418.1 |
關鍵詞 | 臨床試驗; 小兒族群; 研究設計; Clinical trials; Pediatric populations; Research design; |
語文 | 中文(Chinese) |
中文摘要 | 人體臨床試驗的進行對當今醫療作業的進展而言是不可或缺的,其在執行過程中必須滿足已廣為接受的倫理、法律與科學性規範。而透過臨床研究來評估小兒族群的用藥亦是決定小兒用藥安全性與有效性極重要的一環。小兒族群相較於成人具有截然不同的病生理特性,因此,在此族群進行臨床試驗必須合併特殊考量。本篇文章主要透過藥品臨床試驗的基本原則、藥動學特性、研究設計及倫理議題幾個層面來介紹小兒用藥的臨床試驗。 |
英文摘要 | Clinical research involving human is recognized as essential to the advancement of medicine practice and must meet accepted ethical, legal, and scientific standards today as implementing. The performance of clinical studies to evaluate drugs in children is critical for determining the safety and efficacy of medications in children. There are different characteristics in physiology and pathology of pediatric populations compared with adults so that clinical trials for those should be conducted with special considerations. In this article, we introduced the clinical trials for pediatric populations through several aspects, including basic principles of clinical drug research, pharmacokinetic characteristics, research design, and ethical issues. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。