我国儿童药品研发与临床用药安全展望

doi:10.19803/j.1672-8629.20220720

中国药物警戒 ›› 2023, Vol. 20 ›› Issue (1): 1-6.
DOI: 10.19803/j.1672-8629.20220720

我国儿童药品研发与临床用药安全展望

蒋建东

中国医学科学院药物研究院,中国医学科学院医药生物技术研究所,北京 100050

收稿日期:2022-12-12 发布日期:2023-01-19
作者简介:蒋建东,男,教授,中国工程院院士,药理学。中国工程院院士,中国医学科学院药物研究院院长,医药生物技术研究所病毒研究室主任,国务院学位委员会委员,中国药学会副理事长,中国医药创新促进会副会长。主要从事抗病毒,抗代谢性疾病和抗肿瘤的新药研究,发现了新的降血脂信号通路机理及药物,发现了新的难以引起耐药的抗病毒机理、靶点与药物。获得国家科技进步二等奖及国家自然科学二等奖等奖项,近年来主持了4项重大国际合作项目。
基金资助:
国家自然科学基金资助项目（82151525）; 国家科技重大专项重大新药创制（2018ZX09721003-008-026）

Development and clinical safety of paediatric medicines in China

JIANG Jiandong

Institute of Pharmaceutical Science, Chinese Academy of Medical Sciences & Peking Union Medical College, Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100050, China

Received:2022-12-12 Published:2023-01-19

摘要/Abstract

摘要： 目的探讨我国儿童药品研发的方向与路径,为提高儿童临床用药安全性提供建议。方法分析整理近年来国内外儿童药品研发和临床用药的政策、法规与相关文献,介绍我国儿童药品研发的现状与不足,厘清影响儿童药品临床用药安全性的因素。结果和结论 针对儿童药品领域的难题,参考相关先进经验,对我国儿童药品研发和临床用药安全进行展望,并提出了对策和建议。

关键词: 儿童药品, 药品研发, 临床用药安全, 现状, 展望

Abstract: Objective To explore the priorities of development of paediatric medicines in China and give advice on the safety of paediatric drugs in clinical use. Methods By analyzing the guidelines, regulations and related literature on development of paediatric medicines and clinical use at home and abroad in recent years, the status quo of and problems with development of paediatric medicines in China were presented, and the factors influencing the safety of clinical use of paediatric medicines were clarified. Results and Conclusion In view of the challenges to paediatric medicines and with reference to related experience, this paper outlines the prospect of the research and development of paediatric medicines and clinical drug safety in China, and puts forward corresponding countermeasures and suggestions.

Key words: paediatric medicines, drug development, clinical drug safety, current situation, outlook

中图分类号:

R951

蒋建东. 我国儿童药品研发与临床用药安全展望[J]. 中国药物警戒, 2023, 20(1): 1-6.

JIANG Jiandong. Development and clinical safety of paediatric medicines in China[J]. Chinese Journal of Pharmacovigilance, 2023, 20(1): 1-6.

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我国儿童药品研发与临床用药安全展望

Development and clinical safety of paediatric medicines in China

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