Liu Hui-chen
2011
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Journal
Chinese Journal of New Drugs
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 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 food-effect bioequivalence studies,exclude poor metabolizers from subjects in bioequivalence studies,choose corresponding original drugs as reference preparations,standardize bioanalytical method validation,and perform post-marketing bioequivalence re-evaluation or monitoring.