摘要
肠溶制剂的生物等效性试验是仿制药质量和疗效一致性评价的难点之一。本文以质子泵抑制剂类代表药物奥美拉唑为例,总结和分析了奥美拉唑肠溶制剂通过仿制药质量和疗效一致性评价的生物等效性试验情况,就试验内容、试验设计及样本量等提出一些建议,旨在为今后开展奥美拉唑肠溶制剂生物等效性试验提供参考。
The bioequivalence studies of enteric-coated preparations are one of the difficulties in the generic drug consistency evaluation.Omeprazole is a representative drug of proton pump inhibitors(PPIs).This article summarizes and analyzes the bioequivalence studies of omeprazole enteric-coated preparations which have passed through the generic drug consistency evaluation.Some suggestions are put forward for the content,design and sample size of the bioequivalence studies,aiming to provide reference for the bioequivalence studies of omeprazole enteric-coated preparations in the future.
作者
刘曼
刘会臣
LIU Man;LIU Hui-chen(Phase I Clinical Trial Ward,Key Laboratory of Clinical Trial Research in Cardiovascular Drugs,Ministry of Health,Fuwai Hospital,Chinese Academy of Medical Sciences,Beijing 100037,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2023年第6期605-609,共5页
Chinese Journal of New Drugs
关键词
奥美拉唑肠溶制剂
一致性评价
生物等效性试验
omeprazole enteric-coated preparations
generic drug consistency evaluation
bioequivalence study