摘要
质量源于设计(Qb D)在人用药品注册技术要求国际协调会(ICH)和美国食品药品监督管理局(FDA)的有关质量控制文件的推动下,已经成为科学技术与质量风险相结合的系统新研发方法。本文结合ICH及FDA关于Qb D的指南,分析了Qb D的目的,概述了实施Qb D方法的6种要素,列举了目前常用的实施Qb D几种工具:先验知识、风险评估、过程分析、机理模型、实验设计、数据分析,并综述了FDA实施Qb D的情况及获益。Qb D已被国际注册和国际药品研发认识,而对于中国制药工业来说,为提高药物研发和审评的质量和水平,国家食品药品监督管理局(CFDA)在技术指导文件和监管法律法规层面逐步实现与国际接轨,Qb D将有利于提高我国制药业整体的质量水平。
Quality by design (QbD) has become a new method combinate science with quality risk in drug research and development, driveing by guidelines do ICH and FDA. This paper analyzes the purpose of QbD, summarizes six el- ements to implement QbD, lists the currently popular QbD tools to opreation: prior knowledge, risk assessment, mechanical model, process analytical technology, design of experiments and data analysis, and summarizes the situation of the FDA's implement QbD and benefit. Be acknowleged by international registration and drug research and develop- ment, QbD will improve the quality of Chiua's pharmaceutical industry. CFDA is implementing regulatory laws and related technical guidances gradually realize international conformity.
作者
苏娴
高云佳
SU Xian GAO Yunjia(Clinical Research Institute, Peking University, Beijing 100191, China Center for Modernization of Traditional Chinese Medicine, Peking University, Beijing 100191, China)
出处
《中国医药导报》
CAS
2017年第29期178-180,共3页
China Medical Herald
关键词
质量源于设计
药品研发
设计空间
关键质量属性
Quality by design
Pharmaceutical research and development
Design space
Critical quality attribute