The safety of biological preparations. Part 2. Safety issues of biosimilars

The use of the reduced scheme in preclinical and clinical studies of «biosimilars» requires special attention to the safety issues. During the process of the marketing authorization of biosimilars in 2013-2015 the countries with advanced regulatory and pharmacovigilance systems (USA, Canada and EU c...

Full description

Saved in:

Bibliographic Details
Main Authors:	A. A. Soldatov, Zh. I. Avdeeva, Yu. V. Olefir, V. A. Merkulov, V. P. Bondarev
Format:	Article
Language:	Russian
Published:	Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2018-02-01
Series:	Биопрепараты: Профилактика, диагностика, лечение
Subjects:	биоподобные препараты биоаналоговые препараты препараты «non-innovators» «biosimilars» экстраполяция результатов взаимозаменяемость препараты моноклональных антител биоаналоговые инсулины biosimilars «non-innovators» preparations extrapolation of the results interchangeability preparations of monoclonal antibodies biosimilar insulins
Online Access:	https://www.biopreparations.ru/jour/article/view/46
Tags:	Add Tag No Tags, Be the first to tag this record!

Be the first to leave a comment!

The safety of biological preparations. Part 2. Safety issues of biosimilars

Similar Items