成人用药数据外推至儿科人群的技术要求及审评考虑

发布时间：2018-05-30 05:08

  本文选题：数据外推 + 儿童用药品　； 参考：《中国新药杂志》2017年18期

【摘要】：儿童药短缺及其带来的儿科人群临床超说明书用药现象是困扰全球的严峻问题。鉴于儿科人群药物临床试验难以开展,将成人数据外推至儿科人群的方法,可以最大化利用现有数据、减少不必要的儿科试验,从而加速儿童药的研发,是保障儿童药临床需求、并用科学的方法保证其安全性、有效性的最有效措施之一。本文分析了我国的现状和近年来鼓励儿童药研发的政策背景,介绍了CFDA最新发布的《成人用药数据外推至儿科人群的技术指导原则》、中国数据外推的模式和几种常见的应用数据外推的情况;并从药品审评角度提出了建议优先开展外推的儿童药种类、及对其审评资料的考虑,以期促进和引导我国数据外推的开展。
[Abstract]:The shortage of drugs in children and the phenomenon of clinical overdose in pediatric population are serious problems all over the world. Given the difficulty of conducting clinical trials of paediatric drugs, the method of extrapolating adult data to paediatric populations can maximize the use of available data and reduce unnecessary paediatric trials, thus accelerating the development of drugs for children, It is one of the most effective measures to ensure the safety and effectiveness of children's drugs. This paper analyzes the present situation of our country and the policy background of encouraging drug development for children in recent years. The technical guidelines for extrapolation of adult drug use data to pediatrics population released recently by CFDA, the data extrapolation model in China and the extrapolation of several common applied data were introduced. From the point of view of drug evaluation, this paper puts forward the suggestion of giving priority to the extrapolation of children's drugs and the consideration of the evaluation data in order to promote and guide the extrapolation of data in our country.
【作者单位】： 国家食品药品监督管理总局药品审评中心;
【分类号】：R95
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本文编号：1954044