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Vol. 21, Art. 12 (pp. 127-140)    |    2020       

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Main areas for using health-associated reference intervals for toxicological studies.

«Institute of Toxicology» of Federal Medico-Biological Agency of Russia

Brief summary

The article substantiates the approaches to determining the reference intervals of biometric features of laboratory animals and the main directions of their use in conducting scientific toxicological studies. It is shown that the procedure for establishing reference intervals is normatively fixed in international and domestic documents and they are widely used in clinical practice. At the same time, the methodological basis for obtaining and using reference intervals during experimental toxicological studies is not fully represented. The increasing importance of the preclinical stage of drug development, for example, in the study of the effectiveness and safety of antidotes, which are possible mainly in laboratory animals, requires an increase in the validity of decisions. The implementation of methodological approaches and the establishment of reference intervals on the basis of a research institution will improve the quality of the preclinical stage of the development of therapeutic and preventive pharmacological preparations, as well as interpretation of the results of toxicological studies based on an integrated assessment of the state of the organism of laboratory animals.


Key words

reference interval, laboratory animals, toxicological study, interpretation of results, quantitative integral assessment

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