中国临床药理学杂志2024，Vol.40Issue(9)：1360-1362,3.DOI:10.13699/j.cnki.1001-6821.2024.09.025
吸入制剂生物等效性试验中受试者管理的关键要素
Key factors for subject management in bioequivalence trials of orally inhaled drug products
摘要
Abstract
Due to the unique characteristics and complexity of administration of orally inhaled drug products,bioequivalence trial for orally inhaled generic drugs presents greater challenges in clinical implementation compared to conventional oral administration.This difficulty is particularly evident inmainly attributed to the variability during the self-administration inhalation of inhaled drugss by subjects.Therefore,effective management of subjects is crucial in clinical trials involving orally inhaled products.This paper,based on the experience in conducting bioequivalence trials for orally inhaled drug products,discusses key factors and measures for successful subject management in clinical trials.The aim is to enhance the clinical implementation capabilities of researchers in the evaluation of generic consistency for inhaled drug products and to ensure the quality of clinical trials.关键词
经口吸入制剂/生物等效性试验/受试者管理Key words
orally inhaled drug products/bioequivalence trial/subject management分类
医药卫生引用本文复制引用
王晶晶,张菁,魏琼,曹钰然..吸入制剂生物等效性试验中受试者管理的关键要素[J].中国临床药理学杂志,2024,40(9):1360-1362,3.基金项目
上海申康医院发展中心研究型医师创新转化能力培训基金资助项目(SHDC2022CRS004B) （SHDC2022CRS004B）
