中国临床药理学杂志2017，Vol.33Issue(13)：1244-1247,4.DOI:10.13699/j.cnki.1001-6821.2017.13.021
Ⅰ期药物临床试验质量管理的特点
Characteristic of drug phase Ⅰ clinical trial under new conditions
摘要
Abstract
Drug phase Ⅰ clinical trials not only bridge the preclinical and subsequent phase Ⅱ and Ⅲ clinical studies but also benefit for early efficacy and safety assessment,development strategy and risk assessment.Good quality management and control can ensure true and accurate results and provide the important reference for the recommended dosage and administration plan.We will present the quality management of phase Ⅰ clinical trials under new situations from both clinical and bioanalysis parts,hoping to ensure the medication safety of peoples and assist healthy China.关键词
药物/Ⅰ期临床试验/质量管理Key words
drug/phase Ⅰ clinical trial/quality management分类
医药卫生引用本文复制引用
杜萍,李鹏飞,刘丽宏..Ⅰ期药物临床试验质量管理的特点[J].中国临床药理学杂志,2017,33(13):1244-1247,4.基金项目
国家重大新药创制科技重大专项基金资助项目(2014ZX09303302) （2014ZX09303302）
北京市自然科学基金资助项目(7164262) （7164262）
