Pharmacovigilance of biosimilars: challenges and possible solutions

被引：4
|
作者：
Giezen, Thijs J. [1 ]
Straus, Sabine M. J. M. [2 ]
机构：
[1] Hosp Med Spectrum Twente, Clin Pharm, Postbus 50000, NL-7500 KA Enschede, Netherlands
[2] Erasmus Univ, Med Ctr, Dept Med Informat, Rotterdam, Netherlands
来源：
GABI JOURNAL-GENERICS AND BIOSIMILARS INITIATIVE JOURNAL | 2012年 / 1卷 / 3-4期
关键词：
Biologicals; biosimilars; immunogenicity; pharmacovigilance; traceability;
D O I：
10.5639/gabij.2012.0103-4.033
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
Post-marketing surveillance is essential to detect, assess and prevent adverse reactions of chemically synthesized small molecule drugs as well as biologicals, as the full safety profi le can only be known after they have been placed on the market. Biologicals have specific characteristics, which pose additional challenges in pharmacovigilance.
引用
收藏
页码：118 / 119
页数：2
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