Analysis of the reasons for failure in screening healthy subjects for bioequivalence test in Phase ⅠLaboratory of Yueyang Second People′s Hospital
LI Yan
1.Xiangya School of Pharmaceutical Sciences,Central South University,Hu′nan Province,Changsha 410000,China;
2.National Institute for Drug Clinical Trial,Yueyang Second People′s Hospital,Hu′nan Province,Yueyang 414000,China
Abstract：Objective To analyze the reasons of failure in screening healthy subjects for bioequivalence test in PhaseⅠLaboratory of Yueyang Second People′s Hospital.Methods The screening data of healthy subjects in bioequivalence test conducted in Yueyang Second People′s Hospital from June 2020 to October 2020 were retrospectively analyzed.The reasons for the failure of screening were discussed from the aspects of subject recruitment,vital signs,compliance and laboratory examination items.Results A total of 4 studies were collected in this study,111 healthy subjects were screened,72 successful subjects(64.86%)were screened.There were no significant differences in the proportion of male and female,age between successful and failure subjects(P>0.05).The main causes of failure were laboratory examination results,compliance and vital signs.Conclusion Laboratory examination,compliance and vital signs are the important reasons for the failure of screening healthy subjects.It is suggested that the success rate of screening healthy subjects should be improved by establishing appropriate range of laboratory indicators and strengthening informed consent.
李燕. 岳阳市二人民医院Ⅰ期研究室生物等效性试验健康受试者筛选失败原因分析[J]. 中国当代医药, 2021, 28(22): 45-47.
LI Yan. Analysis of the reasons for failure in screening healthy subjects for bioequivalence test in Phase ⅠLaboratory of Yueyang Second People′s Hospital. 中国当代医药, 2021, 28(22): 45-47.
京公网安备 11010502046607号