Альтернативные методы по оценке токсичности в рамках этической экспертизы. Обзор

DOI: 10.29296/2618723X-2022-01-07

M.N. Makarova, ORCID 0000-0003-3176-6386

V.G. Makarov, 0000-0002-2447-7888

Research and manufacturing company «Home оf Pharmacy»,
188663, Russia, Leningrad oblast, Vsevolozhskiy district, Kuzmolovskiy t.s., Zavodskaya st. 3-245

e-mail: [email protected]

Keywords: laboratory animals directive ethical review

For citation:

Makarova M.N., Makarov V.G. Альтернативные методы по оценке токсичности в рамках этической экспертизы. Обзор . Laboratory Animals for Science. 2022; 1. https://doi.org/10.29296/2618723X-2022-01-07


Today there are very strict rules for toxicological studies of chemicals, including drugs. Traditionally, it includes animal studies. At the same time, public opinion and government initiatives based on it keep suggesting reducing the number of animals in research. This can be done by careful ethical review, assessment of the benefit-to-harm ratio, and replacement with alternative research methods. However, there are no specific requirements for the ethical review of the planned studies which involves the use of laboratory animals, or for the search for suitable alternatives.

This review speaks on and systematizes the ways to evaluate alternative research methods without the use of animals in toxicological studies.

All the data is summarized in a tables, which includes a specific section of toxicology research in vitro, relevant and approved in vitro methods that could replace animal studies. Each alternative method is considered in terms of its applicability to this type of study, its reliability (validation characteristics), and the limitations of its use.

When analyzing alternative methods, it is necessary to consider physical and chemical properties of the studied drug and its aggregate state (or drug form). The table provides the data about the type of validation and its results which will help to understand the degree of reliability of the method and its compliance with the purposes of the study. The inability to assess the effect of the studied substance on the organism, considering the first and second phases of biotransformation, remains the main problem of in vitro methods today. This should also be taken into account for substances that are certainly known to undergo metabolism and their metabolites have a biological effect.

Full text avaliable in Russain only 


The study was performed without external funding.

Authors contribution 

M.N. Makarova – idea, analysis of scientific and methodological literature, writing, editing and revision of the text of the manuscript, responsibility for all aspects of the work related to the reliability of data.

V.G. Makarov – writing and editing the text of the manuscript, summarizing the results.

Conflict of interest

Makarov V.G. is the editor-in-chief of the journal.


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