基于案例浅谈食物影响研究相关问题  

Discussion on food impact during oral drug development though case studies

作　　者：刘霏霏 李健 刘意林 高丽丽 贺锐锐 LIU Fei-fei;LI Jian;LIU Yi-lin;GAO Li-li;HE Rui-rui(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076

出　　处：《中国临床药理学杂志》2024年第21期3206-3210,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：药物与食物同服可能对药物的吸收和系统暴露产生影响,进而引起药物在治疗疾病时的安全性和有效性发生改变。食物影响研究在药物研发中非常重要,食物通过对药物作用机制和机体生理环境等的作用对药物的安全性和有效性产生显著影响,包括对药物研发过程、上市后药物临床应用及患者的依从性。不同的膳食结构也可能导致食物对药物影响的程度发生变化。本文就口服给药的药物制剂,结合经典的药物研发案例,根据相关法规和指导原则等,从药物研发案例中食物影响研究思路出发,分析食物影响研究在药物研发过程中的重要作用,阐明药物临床药理食物影响特性,明确实际用法用量,为药物研发中食物影响研究设计等提供参考。Co-administration of an orally administered drug with food can increase the systemic exposure of the drug,to have a significant impact on the safety and efficacy of orally administered drug products.Food-effect studies is very important in drug development.Food exerts its effects on the mechanisms of drug action and physiological environment of the body,to have a significant impact on the safety and efficacy of drugs,including the drug development process,post market clinical application of drugs,and patient compliance.The effect of food is different across meals with different fat or caloric contents.This article discusses orally administered drug products,combining drug development cases,according to relevant regulations and guidelines,starting from the approach of food-effect studies in drug development,to analyze the key role of food-effect studies in the drug development process,to elucidate the clinical pharmacology and food-effect characteristics,to clarify the actual usage and dosage,to provide reference for the design of food-effect studies in drug development.

关 键 词：食物影响研究 口服药物 药物研发案例 用法用量 

分 类 号：R97[医药卫生—药品]