中国临床药理学杂志2024，Vol.40Issue(17)：2572-2574,3.DOI:10.13699/j.cnki.1001-6821.2024.17.024
健康绝经期女性受试者在生物等效性试验中筛选失败原因分析
Analysis of reasons for failure in screening healthy menopausal female subjects in a bioequivalence trial
沈珍 1樊莲莲 1李慕鹏 1甘春燕 1申屠建中2
作者信息
- 1. 德阳市人民医院Ⅰ期临床研究中心,四川德阳 618000
- 2. 德阳市人民医院Ⅰ期临床研究中心,四川德阳 618000||浙江大学医学院附属第一医院临床研究中心,浙江杭州 310003
- 折叠
摘要
Abstract
Objective To clarify and analyze the reasons for failure in screening healthy menopausal female in a bioequivalence trial.Methods To summarize and clarify the data of 185 healthy menopausal female subjects participating in a bioequivalence trial of estradiol valerate conducted,and summarize the reasons for screening failure.Results The main reasons for screening failure include laboratory tests(32.04％),gynecological transvaginal color Doppler ultrasound(16.57％),vital signs(14.36％),chest computed tomography(CT,11.60％),and medical history/medication history(7.73％).Conclusion Screening failures in healthy menopausal female subjects were characterized mainly by abnormal gynecological transvaginal color Doppler ultrasound and non-compliance with basal hormone levels compared to generally healthy subjects.关键词
戊酸雌二醇/生物等效性试验/健康绝经期女性受试者/受试者筛选/特殊检查Key words
estradiol valerate/bioequivalence trial/healthy menopausal female subjects/subjects screening/special examination分类
药学引用本文复制引用
沈珍,樊莲莲,李慕鹏,甘春燕,申屠建中..健康绝经期女性受试者在生物等效性试验中筛选失败原因分析[J].中国临床药理学杂志,2024,40(17):2572-2574,3.
