重组蛋白多肽药物生物等效性研究的必要性、可行性和方法学  

The significance,feasibility and methodology of bioequivalence studies on recombinant protein or peptide

作　　者：汤仲明[1] 刘秀文[1] 窦桂芳[1] 宋海峰[1] 朱宝珍[1] 

机构地区：[1]军事医学科学院放射医学研究所生物技术药物代谢实验室,北京100850

出　　处：《中国新药杂志》2001年第9期646-650,共5页Chinese Journal of New Drugs

基　　金：国家自然基金资助重点项目 ( 39930 180 )

摘　　要：首先简单综述了国外对重组蛋白或多肽生物等效性研究的概况和实例。重点讨论了药品生产厂家和管理当局对药物开发不同阶段生物等效性评价必要性的认识 ,介绍了生物等效性评价的方法和结果。然后详细介绍了本实验室进行重组蛋白或多肽药物生物等效性研究的经验、方法和结果。最后强调了生物等效性研究对于化学药物和生物制品的同等重要性。重组蛋白或多肽药物浓度测定常用方法是酶联免疫吸附测定 (ELISA) 。In the first part of this paper,the bioequivalence studies on recombinant protein or peptide in abroad and examples were briefly reviewed,and the significance of bioequivalence studies at different stage of new drug development for pharmaceutical companies and regulatory agencies were emphasized.In the second part of this paper,the experiences,methodology,and results of our laboratory on evaluation of bioequivalence on recombinant protein or peptide were introduced in detail.We emphasized in the conclusion that the bioequivalence study for chemical drugs is as important as for biological products.The commonly used method for determination of protein or peptide in plasma is enzyme linked immunosorbent assay(ELISA) method,and bioassay is also necessary sometimes.

关 键 词：生物等效性 重组蛋白 多肽 酶联免疫吸附测定 生物检定 

分 类 号：R927.11[医药卫生—药学] R977.6