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Year 2016
Number 1 Number 2

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

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Reviews

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.

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