The Influence of Gender Factors on Subjects Screening in Bioequivalence Test
10.3870/j.issn.1004-0781.2025.05.027
- VernacularTitle:性别因素对生物等效性试验受试者筛选的影响
- Author:
Yunshan HE
1
;
Jianjun ZHOU
;
Lilan PENG
;
Hongli ZOU
;
Guojiang PENG
;
Niuxiu LI
Author Information
1. 湘南学院附属医院药物临床试验机构办公室,郴州 423000;湘南学院附属医院Ⅰ期临床试验研究室,郴州 423000
- Publication Type:Journal Article
- Keywords:
Bioequivalence studies;
Subjects;
Gender differences;
Cause analysis
- From:
Herald of Medicine
2025;44(5):834-839
- CountryChina
- Language:Chinese
-
Abstract:
Objective To explore the impact of gender factors in participant selection during bioequivalence studies,and to provide insights for improving the screening success rate in subsequent trials.Methods A retrospective study was con-ducted to summarize the screening information of healthy subjects in the bioequivalence study conducted in the Phase Ⅰ Clinical Trial Laboratory of the Affiliated Hospital of Xiangnan University from July 2021 to July 2023.The number of failed screening ca-ses in different stages of screening for each project was counted,and the influence of gender factors on subject screening was ana-lyzed.Results A total of 32 bioequivalence studies involving 2 794 subjects,including 1 816 males and 978 females,were in-cluded in the study.The proportion of males was higher in vital signs and BMI abnormalities,and the proportion of females was higher in ECG abnormalities and active withdrawal,and the pass rate was lower in males than in females(40.0％ vs.45.8％),and the existence of the two was statistically significant(P＜0.05).The results of PC A showed that the distribution of data in males was more dispersed,and the distribution of data in females was centralized,and the two could be clearly differentiated.Binary lo-gistic regression analysis showed significant differences between males and females in laboratory test screening failures and BMI(P＜0.05).Further analysis showed that the screening failure rates of blood biochemistry,urine routine,coagulation function and blood transfusion were higher in males than in females,but the screening failure rates of blood routine were lower than those of fe-males.Conclusions Gender is an important influencing factor in the screening process of bioequivalence studies.Including subjects with appropriate gender ratios can help improve enrollment speed and reduce clinical trial costs.
