对缬沙坦胶囊生物等效性试验现状的分析
Analysis of the current situation of bioequivalence trails of valsartan capsules
刘陆阳 1田丽娟1
作者信息
- 1. 沈阳药科大学工商管理学院,沈阳 110016
- 折叠
摘要
缬沙坦胶囊是治疗原发性高血压的常用药,是目前仿制药质量和疗效一致性评价重点关注的品种之一.通过在国家药品监督管理局药品审评中心官网上检索已经通过仿制药质量和疗效一致性评价的缬沙坦胶囊生物等效性试验,分析不同企业的试验设计和结果.分析发现不同企业采用的试验设计各不相同,样本量、主要药动学参数的比值和个体内变异系数差异较大.为了降低试验失败的风险、提高试验的科学性和效率,建议应进行充分的药学研究,并且开展空腹和餐后的生物等效性预试验,根据预试验结果合理选择正式试验的设计、样本量.
Abstract
Valsartan capsules are commonly used to treat essential hypertension.Now,this product is one of the important formulations in the generic drug consistency evaluation.By retrieving the bioequivalence trials of valsartan capsules which have passed through the generic drug consistency evaluation in the website of CDE,NMPA,the trial designs and results of different enterprises were analyzed.It was found that the trial designs were much different among enterprises.And there were differences in the sample size and the ratio and CVintra of main pharmacokinetic parameters.In order to reduce the risk of failure and increase the scientificity and efficiency of a trial,it is very necessary to optimize the formulation and process of formulations through pharmaceutical research,conduct pilot trails,and then determine the design and sample size of the pivotal trails.
关键词
缬沙坦/口服制剂/一致性评价/生物等效性试验Key words
valsartan/oral formulations/generic drug consistency evaluation/bioequivalence引用本文复制引用
出版年
2024
NETL
NSTL
万方数据