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
王晶晶 1张菁 1魏琼 1曹钰然1
作者信息
- 1. 复旦大学附属华山医院临床药理研究中心,上海 200040
- 折叠
摘要
经口吸入制剂由于自身的特殊性和给药复杂性,其仿制药生物等效性试验在临床实施过程中比一般的口服给药难度大,尤其体现在受试者自主进行吸入给药过程中可能产生的偏差.因此在经口吸入制剂临床试验中受试者的管理尤为重要.本文基于研究团队完成的经口吸入制剂生物等效性试验经验,探讨做好临床试验中受试者管理的关键要素及措施,旨在提高吸入制剂仿制药一致性评价中研究者的临床实施能力,确保临床试验质量.
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引用本文复制引用
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(SHDC2022CRS004B)
出版年
2024
国家科技期刊平台
NSTL
万方数据