Analysis of reasons for failure in screening healthy menopausal female subjects in a bioequivalence trial
10.13699/j.cnki.1001-6821.2024.17.024
- VernacularTitle: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
- Author:
Zhen SHEN
1
;
Lian-Lian FAN
;
MU-Peng LI
;
Chun-Yan GAN
;
Jian-Zhong SHENTU
Author Information
1. 德阳市人民医院Ⅰ期临床研究中心,四川德阳 618000
- Keywords:
estradiol valerate;
bioequivalence trial;
healthy menopausal female subjects;
subjects screening;
special examination
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(17):2572-2574
- CountryChina
- Language:Chinese
-
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.
