口溶膜剂生物等效性试验研究中的受试者管理要点  

Points for Subject Consideration in Bioequivalence Pilot Studies of Oral Soluble Membrane Agents

作　　者：张娟[1] 程敏 胡彩露 张飞 ZHANG Juan;CHENG Min;HU Cailu;ZHANG Fei(The Central Hospital of Wuhan,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430014,China)

机构地区：[1]华中科技大学同济医学院附属武汉中心医院,武汉430014

出　　处：《药学与临床研究》2024年第5期476-477,共2页Pharmaceutical and Clinical Research

摘　　要：口溶膜作为一种新型口服给药系统,相较于传统口服片剂,其生物等效性临床研究实施过程面临较大挑战。本文综述在临床研究中,研究者需对受试者行为判定、服药训练及给药主观指标评价等行为进行严格且规范化的管理,以保障临床试验高质量开展。As a novel oral drug delivery system,oroally dissolved films face greater challenges in the implementation process of bioequivalence clinical researches compared with traditional oral tablets.This article reviews that,in clinical researches,researchers need to perform strict and standardized management of subject behaviors such as subject behavior judgment,medication training and evaluation of subjective indicators to ensure high-quality conduct of clinical trials.

关 键 词：口溶膜 生物等效性试验 受试者管理 质量 

分 类 号：R943[医药卫生—药剂学]