FDA儿科临床药理学研究指导原则简介

Introduction of guideline for general clinical pharmacology considerations for pediatric drug products from FDA

儿科临床药理学是临床药理学的一个重要内容,是儿科临床安全有效用药的理论基础,急待加速发展。FDA于2014年12月发布了《儿科临床药理学研究指导原则草案》,详细描述了儿科临床药理学的研究内容和方法。本文介绍该指导原则的主要内容,期望对促进我国儿科临床药理学发展和加强注册药品相应内容的管理有益。

The clinical pharmacology of pediatrics is the major part of clinical pharmacology,which is expected to develop rapidly,and it is the academic basis of safe and efficient use of drugs in pediatrics. In december 2014,FDA addressed the draft guideline of ＂General clinical pharmacology considerations for pediatric drug products ＂recounting the content and method of clinical pharmacology of pediatrics. Here,we introduce the main content of the above guideline hoping to improve the native development of clinical pharmacology of pediatrics and reinforce the supervision on registration drugs.