国内奥美拉唑(盐) 口服制剂人体生物等效性试验的问题和对策.pdfVIP

Chinese Journal ofN ew Drugs 2011, 20(4) () 1, 2 1 , ( 1航天中心医院临床药理室, 北京 100049; 2山东大学药学院, 济南 250012) [] 奥美拉唑是质子泵抑制剂类 表药物, 临床上应用广泛文中通过对国内 26篇奥美拉唑 (盐)口服制剂人体生物等效性试验文献进行分析, 探讨了试验内容参比制剂受试者生物样品采集及分 析药动学参数上市后生物等效性再评价或监测等方面的问题和对策, 以期为奥美拉唑(盐)口服制剂人体 生物等效性研究和临床应用提供参考信息, 并基于现有研究状况提出以下建议: 开展食物影响研究在受试 者筛选时排除弱 谢者参比制剂选择相同剂型的原创药规范分析测定方法的确证并开展和加强奥美拉唑 (盐)口服制剂的上市后生物等效性再评价或监测 [] 奥美拉唑; 药动学; 生物等效性 [] R975 [] A [] 1003- 3734( 2011) 04- 0320- 05 P rob lem s and coun term easures in dom estic hum an b ioequ ivalence studies for th e oral p reparation s con tain ing om eprazole or its salt 1, 2 1 WANG X iaolin , LIU Huichen ( 1D ep artm ent of C lin ical Pharmacology, A erosp ace CenterH osp ital, B eij ing 100049, China; 2College of Pharmacy, Shandong Univ ersity, J inan 250012, China [ Abstract] Omeprazole is a representative drug of the proton pump inhibitors ( PPIs), and has been ap pliedw idely in clinical therapy. H ere, we summarized 26 domestic references of human bioequivalence researches for the oralpreparations containing om eprazole or its salt. The problem s and counterm easures referred to expermi ent contents, reference preparations, subjects, collection and analysis of biological samples, pharmacokinetic parame ters, and postmarketing bioequivalence reevaluation ormonitoring were described and discussed. The goal is to provide useful reference information for human bioequivalence research and clinical application of omeprazole or its salt. Based on the current research situation, it is advisable to carry out foodeffect bioequivalence studies, exclude poormetabolizers from subjects in bioequivalence studies, choose corresponding original drugs as re