摘要
在传统的"经验描述"新药开发模式下,创新药研发无法综合利用已有信息,开发效率低下,并且容易引发安全性隐患。因此,探索并建立更高效更安全的创新药物临床开发新模式和新机制尤为必要。近年来,FDA和EMEA陆续提出并践行的以"知识综合"为特征的药物临床研究模式就是其中的重要代表。它利用模型与模拟技术定量地综合分析和预测创新药在患者体内的暴露/效应关系及其影响因素,帮助在获取足够信息的同时,在临床试验中尽量减少所需受试者数量,并保障临床试验的安全性。
Under the traditional＂empirical trial design＂, innovative drug development cannot make comprehensive use of the existing information from previous studies. The development efficiency is low. And it is easy to cause safety issues.Therefore, it is particularly necessary to explore and establish new models, more efficient and safer strategies for the clinical development of innovative drugs. In recent years, the＂knowledgeable＂clinical research strategy for new drug has been proposed and practiced by the FDA and EMEA. It employed the model and the simulation technology to quantitatively analyze and predict exposure/response relationships of innovative drug and its influence factors in patients.It helped in obtaining sufficient information from clinical data at the same time, to minimize the required number of subjects, and to ensure the safety of subjects in clinical trials.
出处
《世界科学技术-中医药现代化》
CSCD
2017年第7期1113-1117,共5页
Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology
基金
国家"十二五"重大新药创制专项(2012ZX09303006-002):自身免疫病
糖尿病及骨质疏松药物新药临床评价研究技术平台
课题负责人:胡蓓
张奉春
国家"十三五"重大新药创制专项(2017ZX09304031-001):"创新药物早期临床药理学评价技术平台建设
负责人:赵维刚
