儿童用药口感研究设计与评价的审评考虑

Review considerations on the design and evaluation of the oral sensory features in pediatric medications

近年来,我国采取一系列措施鼓励儿童用药研发生产,满足儿童用药需求。儿童因其生理和心理发育特点,在不良感觉的耐受性方面与成人不同,口感不佳所导致的不良用药行为风险在儿童也相应增高,因此良好口感在儿童用药开发时具有更强的临床意义与价值。2022年11月国家药品监督管理局药品审评中心发布了《儿童用药口感设计与评价的技术指导原则(试行)》,本文将结合《指导原则》内容,就其撰写背景、相关审评考虑予以介绍,以期为儿童用药口感设计与评价提供参考,助力儿童用药研发。

Recent years,China has released a series of policies to encourage drug research and development in pediatric populations,aiming to meet pediatric populations'medical needs.Because of the physical and psychological developmental characteristics,tolerance of aversive feelings when taking medications are different between pediatric population and adults.So pediatric populations are at a relatively higher risk of not taking medications as prescribed when the medication tasted unpleasant.Therefore,sound design and evaluation of oral sensory features have important clinical significance and value in developing pediatric medications."Technical guidance for the design and evaluation of the oral sensory features of pediatric drugs(trial version)"was released in November 2022,by Centre for Drug Evaluation,National Medical Products Administration of China.Based on the guidance,this article will introduce the drafting background and review considerations,hoping to provide reference for the design and evaluation of oral sensory features,and promote drug developing in pediatric population.