生物类似药与参照药可比性评价的分析策略

发布时间：2018-04-11 17:29

本文选题：生物类似药 + 参照药　；参考：《中国药事》2016年04期

【摘要】：国内外的药品管理机构均要求生物类似药与一个参照药具有适当可比性的质量、安全和功效。生物类似药开发商需要采用先进的分析技术,描述生物类似药的特征,并与相关的上市参照药比较;目前,可以应用多种分析方法,研究候选生物类似药与参照药的特性,这些方法学可以作为评价生物可比性的证据。本文主要讨论支持生物类似药可比性检验能够采取的分析技术。
[Abstract]:Domestic and foreign drug regulatory agencies require that biological analogous drugs have appropriate comparable quality, safety and efficacy with a reference drug.Developers of biological analogous drugs need to use advanced analytical techniques to describe the characteristics of biological analogous drugs and compare them with relevant marketable reference drugs; at present, a variety of analytical methods can be used to study the characteristics of candidate biological analogous drugs and reference drugs.These methodologies can serve as evidence for evaluating biological comparability.This paper mainly discusses the analytical techniques that can be used to support the comparability test of biological analogous drugs.
【作者单位】：中国食品药品检定研究院;
【分类号】：R95

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