经口吸入和鼻用制剂生物等效性试验实施管理  

Management of bioequivalence trials for orally inhaled and nasal drug products

作　　者：王晓倩 刘红娇 刘川 陈西敬 WANG Xiao-qian;LIU Hong-jiao;LIU Chuan;CHEN Xi-jing(School of Basic Medicine and Clinical Pharmacy,China Pharmaceutical University,Nanjing 211198,China;Clinical Service Center,Beijing 100024,China)

机构地区：[1]中国药科大学基础医学与临床药学学院,南京211198 [2]北京科林利康医学研究有限公司,北京100024

出　　处：《中国新药杂志》2022年第10期983-990,共8页Chinese Journal of New Drugs

基　　金：广州市民生科技攻关计划资助研究课题项目(2018 03010036)。

摘　　要：经口吸入和鼻用制剂处方与制备工艺复杂,给药途径特殊,如何高质量地完成相应的生物等效性试验已成为监管部门和药品生产企业的共同挑战。本文对临床试验调研阶段、启动阶段、实施阶段及结束阶段的操作难点与注意事项进行分析和总结,以期为我国经口吸入和鼻用制剂生物等效性试验的开展提供参考,提高试验的成功率。Orally inhaled and nasal drug products have complex prescriptions and preparation processes, as well as special routes of administration. How to complete the corresponding bioequivalence trials with high quality has become a joint challenge for regulatory authorities and pharmaceutical manufacturers. This article analyzed and summarized the operational difficulties and precautions during the investigation phase, start-up phase, implementation phase and end phase of clinical trials, to provide a reference for the conduction of bioequivalence trials of orally inhaled and nasal drug products in China to improve the success rate.

关 键 词：经口吸入和鼻用制剂 生物等效性 临床运营管理 

分 类 号：R965[医药卫生—药理学]