Current Requirements for and Approaches to Dosing in Animal Studies

Today, within the context of harmonisation of requirements in the international pharmaceutical market, there is a trend towards development of common standards, including in the field of preclinical studies. The reliability and reproducibility of experimental data obtained in various laboratories us...

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Main Authors: A. V. Rybakova, M. N. Makarova, A. E. Kukharenko, A. S. Vichare, F. R. Rueffer
Format: Article
Language:Russian
Published: Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2018-12-01
Series:Регуляторные исследования и экспертиза лекарственных средств
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Online Access:https://www.vedomostincesmp.ru/jour/article/view/163
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author A. V. Rybakova
M. N. Makarova
A. E. Kukharenko
A. S. Vichare
F. R. Rueffer
author_facet A. V. Rybakova
M. N. Makarova
A. E. Kukharenko
A. S. Vichare
F. R. Rueffer
author_sort A. V. Rybakova
collection DOAJ
description Today, within the context of harmonisation of requirements in the international pharmaceutical market, there is a trend towards development of common standards, including in the field of preclinical studies. The reliability and reproducibility of experimental data obtained in various laboratories using animals cannot be guaranteed unless the 3Rs principles are observed (the principles of humane experimental technique) to ensure the welfare of animals. The present paper analyses Russian and foreign recommendations on different administration routes and administered volumes as applied to mice, rats, guinea pigs, and rabbits – the most frequently used laboratory animals.  The paper systematises literature data on oral/intragastric, subcutaneous, intramuscular, intravenous and intraperitoneal routes of administration. It assesses potential complications of each route of administration, and negative effects on both health and well-being of laboratory animals, as well as on the results of experiments. The paper also touches upon some anatomical and physiological characteristics of laboratory animals, potential opportunities for feed and water deprivation, ways of reducing pain in animals. The results of comparison of administered volumes helped to determine optimal recommended and maximum administered volumes.
format Article
id doaj-art-018656d4580c42aaafea4e388fd55109
institution Kabale University
issn 3034-3062
3034-3453
language Russian
publishDate 2018-12-01
publisher Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)
record_format Article
series Регуляторные исследования и экспертиза лекарственных средств
spelling doaj-art-018656d4580c42aaafea4e388fd551092025-08-20T03:40:14ZrusFederal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)Регуляторные исследования и экспертиза лекарственных средств3034-30623034-34532018-12-018420721710.30895/1991-2919-2018-8-4-207-217175Current Requirements for and Approaches to Dosing in Animal StudiesA. V. Rybakova0M. N. Makarova1A. E. Kukharenko2A. S. Vichare3F. R. Rueffer4Scientific and Production Association "HOME PHARMACY"Scientific and Production Association "HOME PHARMACY"Abbott Laboratories LLCAbbott Healthcare Pvt. Ltd.Abbott Laboratories GmbHToday, within the context of harmonisation of requirements in the international pharmaceutical market, there is a trend towards development of common standards, including in the field of preclinical studies. The reliability and reproducibility of experimental data obtained in various laboratories using animals cannot be guaranteed unless the 3Rs principles are observed (the principles of humane experimental technique) to ensure the welfare of animals. The present paper analyses Russian and foreign recommendations on different administration routes and administered volumes as applied to mice, rats, guinea pigs, and rabbits – the most frequently used laboratory animals.  The paper systematises literature data on oral/intragastric, subcutaneous, intramuscular, intravenous and intraperitoneal routes of administration. It assesses potential complications of each route of administration, and negative effects on both health and well-being of laboratory animals, as well as on the results of experiments. The paper also touches upon some anatomical and physiological characteristics of laboratory animals, potential opportunities for feed and water deprivation, ways of reducing pain in animals. The results of comparison of administered volumes helped to determine optimal recommended and maximum administered volumes.https://www.vedomostincesmp.ru/jour/article/view/163administered volumedosinglaboratory animalswell-being of laboratory animalshumane treatment of laboratory animals
spellingShingle A. V. Rybakova
M. N. Makarova
A. E. Kukharenko
A. S. Vichare
F. R. Rueffer
Current Requirements for and Approaches to Dosing in Animal Studies
Регуляторные исследования и экспертиза лекарственных средств
administered volume
dosing
laboratory animals
well-being of laboratory animals
humane treatment of laboratory animals
title Current Requirements for and Approaches to Dosing in Animal Studies
title_full Current Requirements for and Approaches to Dosing in Animal Studies
title_fullStr Current Requirements for and Approaches to Dosing in Animal Studies
title_full_unstemmed Current Requirements for and Approaches to Dosing in Animal Studies
title_short Current Requirements for and Approaches to Dosing in Animal Studies
title_sort current requirements for and approaches to dosing in animal studies
topic administered volume
dosing
laboratory animals
well-being of laboratory animals
humane treatment of laboratory animals
url https://www.vedomostincesmp.ru/jour/article/view/163
work_keys_str_mv AT avrybakova currentrequirementsforandapproachestodosinginanimalstudies
AT mnmakarova currentrequirementsforandapproachestodosinginanimalstudies
AT aekukharenko currentrequirementsforandapproachestodosinginanimalstudies
AT asvichare currentrequirementsforandapproachestodosinginanimalstudies
AT frrueffer currentrequirementsforandapproachestodosinginanimalstudies