[关键词]
[摘要]
为改善儿童用药现状,提高儿童用药水平,保障儿童健康,国家陆续推出了一系列鼓励儿童药物研发的利好政策。随着政策的推行,儿科药物的临床研究势必会越来越多。从事药物研发相关人员应该根据患儿疾病谱、死亡率及死因顺位、疾病负担等临床需求的迫切程度以及儿童用新药的研发需求,选择优先关注的领域,开发以临床价值为导向、与临床实际需求严密结合的儿童用新药。着重介绍了近年来儿童疾病的相关情况以及儿童用药研发方向,旨在为儿童药物临床研发立项的前期评估提供一定参考。
[Key word]
[Abstract]
In order to improve children's medication information, the government has launched a series of positive policies to encourage clinical research on pediatric drugs. Thus the prophase of the project is of great importance, so as to develop clinical value oriented new drugs that focused on the priority area of concern according to the urgent degree of clinical demands. Researchers have to get familiar with the situation of childhood diseases as well as the clinical demand of pediatric medication. This article introduces the children's mortality rate and disease burden, as well as the changes of disease spectrum in recent years. Its purpose is to give reference to pediatric R&D relevant personnel for the prophase of the project.
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