FDA“乳糜泻:开发无麸质饮食辅助治疗药物供企业用的指导原则(草案)”介绍  

Introduction to FDA’s "Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet Guidance for Industry (Draft)"

作　　者：王慧明 萧惠来 WANG Huiming;XIAO Huilai(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《药物评价研究》2023年第1期14-18,共5页Drug Evaluation Research

摘　　要：美国食品药品监督管理局(FDA)于2022年4月发布了“乳糜泻:开发无麸质饮食辅助治疗药物供企业用的指导原则(草案)”。该指导原则草案提出了无麸质饮食辅助治疗药物临床试验方案的建议,详细说明了开发这类药物临床试验关键要素的许多具体建议,包括试验人群、试验设计、疗效及安全性评估等方面。而我国目前尚没有类似的指导原则。详细介绍FDA该指导原则草案主要内容,期望对我国这类药物开发的临床研究及其监管有帮助。The U. S. Food and Drug Administration(FDA) published in April 2022 "Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet Guidance for Industry(Draft)." The draft guideline puts forward recommendations for clinical trial protocols for gluten-free dietary adjuvant therapeutic drugs, detailing many specific recommendations for the development of key elements of clinical trials of such drugs, including trial population, trial design, efficacy and safety evaluation,etc. China currently does not have similar guidelines. Introduce the draft guideline of FDA in detail, hoping to be helpful to the clinical research and supervision of the development of such drugs in China.

关 键 词：美国食品药品监督管理局(FDA) 乳糜泻 无麸质饮食 辅助治疗药物 临床试验方案 指导原则 

分 类 号：R951[医药卫生—药学]