对国内奥美拉唑肠溶制剂生物等效性试验的分析

Analysis of bioequivalence studies of omeprazole enteric-coated preparations in China

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.