摘要
生物等效性(BE)试验作为药物临床试验的一种方式,大量应用于我国仿制药一致性评价。随着我国药物临床试验开展数量逐年递增,保证其过程规范性、数据可靠性变得尤为重要。同时,对于监管部门来说,降低试验风险、提高检查效率和质量,是一直以来研究探讨的方向。本文对生物等效性试验动态现场核查的法规基础、优势和困难、核查的关键要点进行梳理,探讨开展生物等效性试验动态现场核查的可行性,并就目前存在的问题与挑战进行展望,提出继续优化药物临床试验的监管建议。
Bioequivalence testing is a type of clinical trial for drugs,which is widely used in the consistency evaluation of generic drugs in China.With the increasing number of drug clinical trials,ensuring the standardization of their processes and data reliability has become particularly important.Meanwhile,for regulatory authorities,reducing experimental risks and improving inspection efficiency and quality have always been the direction of research and exploration.This article summarizes the regulatory basis,advantages and difficulties,as well as key points of dynamic on-site verification for bioequivalence testing.It explores the feasibility of its conduction and prospects the current problems and challenges.It also proposes regulatory suggestions for further optimizing drug clinical trials.
作者
刘春帅
胡晨希
田媛
徐厚明
LIU Chunshuai;HU Chenxi;TIAN Yuan;XU Houming(Center for Inspection,Jiangsu Medical Products Administration,Nanjing 210019,China)
出处
《药学与临床研究》
2023年第6期560-563,共4页
Pharmaceutical and Clinical Research
关键词
生物等效性试验
动态现场核查
可行性
监管
Bioequivalence
Dynamic on-site verification
Viability
Administration
