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

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Number 1'2016

Requirements for clinical trials of biotechnological drugs. Clinical and pharmacological studies.

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

The review is devoted to the questions concerning features of carrying out clinical trials of the medicines prepared with use of biotechnological methods. The importance of issues related to the stability of the technological process and in-process monitoring to ensure the quality of the drug, safety and efficacy of its clinical use is highlighted. Despite the fact that the general principles of evidence-based clinical studies of drugs concern all biological substances, there are some features that apply only to biotechnological drugs. Thus, the data from preclinical studies evaluating immunogenicity in animals, as a rule, cannot be used to predict immunogenicity of biotechnology medicines in clinical applications, since the proteins and polysaccharides of these medicines are alien to animals and cause the development of the immune response. The data obtained in the group of healthy volunteers, can't fully predict the safety and efficacy of the medicines in patients, in case of existence of their target-mediated effects. Evaluation of pharmacokinetic parameters of peptide or protein preparations has the restrictions connected with methodical features of the analysis, as the protein detection is conducted in a complex biological matrix using immunological methods. The development of an unwanted immune response in clinical application of biotechnological medicines can be accompanied by the formation of antibodies specific to the active drug ingredients whose presence affects the pharmacokinetics and pharmacodynamic properties of the drug. (Cytokines and Inflammation. 2016. Vol. 15. № 1. P. 28–37.)

Keywords: biotechnological medicines, clinical trials, pharmacokinetics, pharmacodynamics, evaluation of immunogenicity, recombinant proteins, monoclonal antibodies.

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