中国临床药理学杂志2025，Vol.41Issue(24)：3575-3579,5.DOI:10.13699/j.cnki.1001-6821.2025.24.020
硫辛酸片生物等效性研究的一般设计要求及相关考虑
General considerations for the design of bioequivalence studies of thioctic acid tablet
李芳 1哈莉莉 1刘力力 1李栋 1任曼茹 1周誉1
作者信息
- 1. 国家药品监督管理局 药品审评中心,北京 100076
- 折叠
摘要
Abstract
Thioctic acid is widely used in clinical treatment of diabetic peripheral neuropathy.The human bioequivalence(BE)study of thioctic acid tablet should follow the relevant regulations and guidelines,and fully consider the particularity of the clinical use of this product.It is recommended to adopt a single dose,two preparations,two sequences,partial or complete repeated crossover study design,and select the reference preparations that have been publicly released for the fasting test.In addition,researchers should pay attention to the Chinese version of The Internationevl Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH)M13A and its Q&A document,as well as the BE study ideas of similar drugs.This article takes the BE study of thioctic acid tablet as an example to provide in-depth guidance for the research.关键词
硫辛酸片/仿制药/生物等效性研究/给药方式Key words
thioctic acid tablet/generic drugs/bioequivalence studies/administration分类
医药卫生引用本文复制引用
李芳,哈莉莉,刘力力,李栋,任曼茹,周誉..硫辛酸片生物等效性研究的一般设计要求及相关考虑[J].中国临床药理学杂志,2025,41(24):3575-3579,5.
