摘要
Ⅰ期药物临床研究桥接了临床前研究和后续的Ⅱ期和Ⅲ期临床研究,对药物的早期有效性和安全性评价、开发策略和风险评估等至关重要。良好的质量管理和控制能够保证试验结果的真实、准确,从而为后续临床试验的推荐给药剂量和给药方案等提供重要参考。本文将从临床部分和检测部分阐述Ⅰ期药物临床试验的质量管理,旨在从源头上切实保障人民群众的用药安全、助力健康中国。
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.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2017年第13期1244-1247,共4页
The Chinese Journal of Clinical Pharmacology
基金
国家重大新药创制科技重大专项基金资助项目(2014ZX09303302)
北京市自然科学基金资助项目(7164262)
关键词
药物
Ⅰ期临床试验
质量管理
drug
phase Ⅰ clinical trial
quality management
