本文選題：數(shù)據(jù)外推 + 兒童用藥品　； 參考：《中國新藥雜志》2017年18期

【摘要】：兒童藥短缺及其帶來的兒科人群臨床超說明書用藥現(xiàn)象是困擾全球的嚴(yán)峻問題。鑒于兒科人群藥物臨床試驗(yàn)難以開展,將成人數(shù)據(jù)外推至兒科人群的方法,可以最大化利用現(xiàn)有數(shù)據(jù)、減少不必要的兒科試驗(yàn),從而加速兒童藥的研發(fā),是保障兒童藥臨床需求、并用科學(xué)的方法保證其安全性、有效性的最有效措施之一。本文分析了我國的現(xiàn)狀和近年來鼓勵(lì)兒童藥研發(fā)的政策背景,介紹了CFDA最新發(fā)布的《成人用藥數(shù)據(jù)外推至兒科人群的技術(shù)指導(dǎo)原則》、中國數(shù)據(jù)外推的模式和幾種常見的應(yīng)用數(shù)據(jù)外推的情況;并從藥品審評(píng)角度提出了建議優(yōu)先開展外推的兒童藥種類、及對(duì)其審評(píng)資料的考慮,以期促進(jìn)和引導(dǎo)我國數(shù)據(jù)外推的開展。
[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.
【作者單位】： 國家食品藥品監(jiān)督管理總局藥品審評(píng)中心;
【分類號(hào)】：R95
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本文編號(hào)：1954044