Intended use of Reference Products & WHO International Standards/Reference Reagents in the development of Similar Biological Products (Biosimilars)

被引：19

作者：

Thorpe, Robin ^{[1
]}

Wadhwa, Meenu ^{[1
]}

机构：

[1] Natl Inst Biol Stand & Controls, Biotherapeut Grp, Potters Bar EN6 3QG, Herts, England

来源：

BIOLOGICALS | 2011年 / 39卷 / 05期

关键词：

Reference product; WHO International Standard/reference reagents; Potency; Bioassay; Comparability studies;

D O I：

10.1016/j.biologicals.2011.06.005

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

Reference Products and WHO International Standards/Reference Reagents have roles to play in the development and characterization of similar biological products (SBPs). However, these roles are distinct and non-interchangeable. The uses of these materials and their limitations are considered in this paper. (C) World Health Organization 2011. All rights reserved. The World Health Organization has granted the Publisher permission for the reproduction of this article.

引用

页码：262 / 265

页数：4

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