| 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 |
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| 引用本文： | 王晓琳,刘会臣. 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[J]. 中国新药杂志, 2011, 0(4): 320-324 |
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| 作者姓名： | 王晓琳 刘会臣 |
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| 作者单位： | 航天中心医院临床药理室;山东大学药学院; |
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| 摘 要： | 奥美拉唑是质子泵抑制剂类代表药物,临床上应用广泛.文中通过对国内26篇奥美拉唑(盐)12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...
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| 关 键 词： | 奥美拉唑 药动学 生物等效性 |
Problems and countermeasures in domestic human bioequivalence studies for the oral preparations containing omeprazole or its salt |
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| WANG Xiao-lin,,LIU Hui-chen. Problems and countermeasures in domestic human bioequivalence studies for the oral preparations containing omeprazole or its salt[J]. Chinese Journal of New Drugs, 2011, 0(4): 320-324 |
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| Authors: | WANG Xiao-lin LIU Hui-chen |
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| Affiliation: | WANG Xiao-lin1,2,LIU Hui-chen1(1 Department of Clinical Pharmacology,Aerospace Center Hospital,Beijing 100049,China,2 College of Pharmacy,Shandong University,Jinan 250012,China) |
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| Abstract: | Omeprazole is a representative drug of the proton pump inhibitors(PPIs),and has been applied widely in clinical therapy.Here,we summarized 26 domestic references of human bioequivalence researches for the oral preparations containing omeprazole or its salt.The problems and countermeasures referred to experiment contents,reference preparations,subjects,collection and analysis of biological samples,pharmacokinetic parameters,and post-marketing bioequivalence re-evaluation or monitoring were described and disc... |
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| Keywords: | omeprazole pharmacokinetics bioequivalence |
| 本文献已被 CNKI 等数据库收录！ |
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