THE SAMPLE SIZE OF LABORATORY ANIMALS FOR EXPERIMENTAL STUDIES

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DOI: https://doi.org/10.29296/25419218-2018-02-01
Issue: 
2
Year: 
2018

M.N. Makarova, MD; E.V. Shekunova, PhD; A.V. Rybakova, PhD; Professor V.G. Makarov, MD HOUM OF PHARMACY Research-and-Production Association; 3, Zavodskaya St., Build. 245, Kuzmolovsky Urban-Type Settlement, Vsevolozhsky District, Leningrad Region 188663

Today, the principles of the 3Rs (Replacement, Reduction, and Refinement), the principles of humane experimental technique, are a generally accepted international standard that can largely decline the number of laboratory animals. At the same time, it is very important that the decline of the number of animals does not contradict the interests of a study or reduce the reliability of experimental findings. The paper analyzes main approaches to determining the sample size of experimental animals at different levels of availability of preliminary information on a test drug. It gives examples of using the power and sample size analysis and resource alignment as ways to assess the sufficient sample size of experimental animals. The authors consider main approaches to selecting the number of animals for use in the study of acute toxicity according to some foreign and Russian guidelines. They analyze the sample size calculation method if there is a sufficient number of preliminary experimental data by the example of assessing biochemical parameters in the study of chronic toxicity. The paper systematizes the recommendations of foreign agencies regulating the circulation of medicines by the selection of the number of experimental animals in relation to study duration, animal age at the beginning of the study, and other factors
Keywords: 
laboratory animals
bioethics
sample size
toxicity
statistical methods of analysis
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