摘要
在生物等效性(BE)试验在准备、进行及结束阶段,虽然研究者对其重点防控点给予重点关注,但仍存在研究者易忽视的问题,应做好易忽视问题的防控,保证临床试验的结果真实可靠。本文通过整理汇总本研究中心几位研究者认为在生物等效性(BE)不同试验阶段中容易被忽视的问题,如方案设计的细节、预试验受试者男女比例、给药前0h生物样本采集及处理时间超窗、给药前0h及冰浴下血样溶血、药品的超湿超温的报警设置、高脂餐是否进食完全、受试者失访的规范记录等,对具体问题进行分析,提出改进措施,以期为从事生物等效性试验的同行提供参考。
Although researchers have paid close attention to key prevention and control points during the preparation,progress and termination of bioequivalence(BE)test,there were still problems that were easily ignored by researchers,so prevention and control of these problems should be done well to ensure the authenticity and reliability of clinical test results.This paper sorts out and summarizes the problems thought to be easily overlooked by several researchers in our research center in different stages of BE test,such as:The details of scheme design,the ratio of male to female subjects in pre-test,the biological samples collection and processing time over the window at 0h before administration,the blood sample hemolysis under ice bath at 0h before administration,the alarm setting of drugs over humidity and temperature,completeness of high-fat meal and the standardized records of the subjects′loss,etc.,analyze the specific problems,and put forward improvement measures,in order to provide reference for peers engaged in BE test.
作者
李灿霞
黄丽凤
雷雨燕
颜羽
卢俊丽
LI Canxia;HUANG Lifeng;LEI Yuyan;YAN Yu;LU Junli(PhaseⅠClinical Laboratory,the Second Nanning People's Hospital,Guangxi,Nanning 530031,China)
出处
《中国医药科学》
2020年第20期234-236,240,共4页
China Medicine And Pharmacy
基金
广西壮族自治区南宁市科学研究与技术开发计划项目(20183047-2)。
关键词
生物等效性试验
不同试验阶段
易忽视问题
改进措施
Bioequivalence test
Different test stages
Problems easily overlooked
Improvement measures
