Научно-практический журнал
[About us] Journal 'Cytokines & Inflammation'

197376, Санкт-Петербург, ул. Акад. Павлова, д. 12,
Институт экспериментальной медицины РАМН
Тел.: (812) 543 52 14, +7 921 984 11 30, +7 921 909 55 49
Факс: (812) 543 52 14
Web: cytokines.ru


Year 2016
Number 1 Number 2

About journal

Current year


Rules for authors

Contact us


Site map

Our partners:


Русский языкEnglish language
Site map Contact us

Contents | Next article | Previous article

Journal 'Cytokines & inflammation', 2016, No. 1

Order this issue

Order PDF of this article


Number 1'2016

Features of clinical trials of biotechnological medicines. Assessment of efficiency, and safety

Zh.I. Avdeeva, A.A. Soldatov, N.A. Alpatova, Yu.V. Olefir, V.A. Merkulov, V.P. Bondarev, V.D. Mosyagin

The review describes the principles of scientifically valid clinical trials of biotechnological medicines conduction. When assessing the efficacy and safety of biotechnological medicines, it should be considered that the research results, obtained in the group of healthy volunteers, not always can be used to predict the ratio of advantage/risk in the case of application of medicines for patients (e.g., for medicines exhibiting target-mediated effects). The formation of antibodies to medicines, the development of undesirable immune response in its clinical application, is accompanied by the development of unforeseen adverse reactions or reduced clinical effect of biotechnological medicine. Evaluation of immunogenic potential of biotechnological medicines should be performed with special attention, both at pre-registration stage and after its state registration. The implementation plan for the risk management is designed to enhance post-marketing pharmacovigilance and monitoring the safety of medicines produced using biotechnology techniques. (Cytokines and Inflammation. 2016. Vol. 15. № 1. P. 38–48.)

Keywords: biotechnological medicines, clinical trials, evaluation of efficacy and safety, clinical endpoints, biomarkers, assessment of immunogenicity, pharmacovigilance.

Contents | Next article | Previous article

© 2007-2017 Cytokines and inflammation