Refining Procedures within Regulatory Toxicology Studies: Improving Animal Welfare and Data
During the development of potential new medicines or agrochemicals, an assessment of the safety profile to humans and environmental species is conducted using a range of different in silico and in vitro techniques in conjunction with metabolism and toxicity studies using animals. The required studie...
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Format: | Article |
Language: | English |
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MDPI AG
2021-10-01
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Series: | Animals |
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Online Access: | https://www.mdpi.com/2076-2615/11/11/3057 |
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author | Helen Prior Hollie Blunt Lee Crossman Aidan McGuire Ruth Stow Fiona Sewell |
author_facet | Helen Prior Hollie Blunt Lee Crossman Aidan McGuire Ruth Stow Fiona Sewell |
author_sort | Helen Prior |
collection | DOAJ |
description | During the development of potential new medicines or agrochemicals, an assessment of the safety profile to humans and environmental species is conducted using a range of different in silico and in vitro techniques in conjunction with metabolism and toxicity studies using animals. The required studies are outlined within international regulatory guidelines which acknowledge and support the application of the 3Rs to reduce the number of animals used or to refine the procedures performed when these studies are deemed to be necessary. The continued development of new technologies and adoption of best-practice approaches to laboratory animal housing and study procedures has generated a series of refinements that can be incorporated into animal studies throughout the package. These refinements benefit the welfare of fish, mice, rats, rabbits, dogs, minipigs, and non-human primates (NHPs) whilst maintaining or improving data quality within general toxicology, metabolism, and other studies and can also bring efficiencies to processes that benefit study costs and timings. Examples are shared which cover the following topics: social housing of dogs and NHPs, surgical refinements in the rat bile duct cannulation model for collection of data for metabolism studies, whether fasting is really required prior to clinical pathology sampling, and the use of microsampling for toxicokinetics. |
first_indexed | 2024-03-09T04:37:32Z |
format | Article |
id | doaj.art-f401756f6a99448998426bb8f1b340f0 |
institution | Directory Open Access Journal |
issn | 2076-2615 |
language | English |
last_indexed | 2024-03-09T04:37:32Z |
publishDate | 2021-10-01 |
publisher | MDPI AG |
record_format | Article |
series | Animals |
spelling | doaj.art-f401756f6a99448998426bb8f1b340f02023-12-03T13:26:58ZengMDPI AGAnimals2076-26152021-10-011111305710.3390/ani11113057Refining Procedures within Regulatory Toxicology Studies: Improving Animal Welfare and DataHelen Prior0Hollie Blunt1Lee Crossman2Aidan McGuire3Ruth Stow4Fiona Sewell5National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), London NW1 2BE, UKSequani Limited, Ledbury HR8 1LH, UKLabcorp Early Development Laboratories Ltd., Harrogate HG3 1PY, UKCharles River Laboratories, Edinburgh EH33 2NE, UKLabcorp Early Development Laboratories Ltd., Harrogate HG3 1PY, UKNational Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), London NW1 2BE, UKDuring the development of potential new medicines or agrochemicals, an assessment of the safety profile to humans and environmental species is conducted using a range of different in silico and in vitro techniques in conjunction with metabolism and toxicity studies using animals. The required studies are outlined within international regulatory guidelines which acknowledge and support the application of the 3Rs to reduce the number of animals used or to refine the procedures performed when these studies are deemed to be necessary. The continued development of new technologies and adoption of best-practice approaches to laboratory animal housing and study procedures has generated a series of refinements that can be incorporated into animal studies throughout the package. These refinements benefit the welfare of fish, mice, rats, rabbits, dogs, minipigs, and non-human primates (NHPs) whilst maintaining or improving data quality within general toxicology, metabolism, and other studies and can also bring efficiencies to processes that benefit study costs and timings. Examples are shared which cover the following topics: social housing of dogs and NHPs, surgical refinements in the rat bile duct cannulation model for collection of data for metabolism studies, whether fasting is really required prior to clinical pathology sampling, and the use of microsampling for toxicokinetics.https://www.mdpi.com/2076-2615/11/11/30573Rsfastingmetabolismmicrosamplingnon-rodentsrefinements |
spellingShingle | Helen Prior Hollie Blunt Lee Crossman Aidan McGuire Ruth Stow Fiona Sewell Refining Procedures within Regulatory Toxicology Studies: Improving Animal Welfare and Data Animals 3Rs fasting metabolism microsampling non-rodents refinements |
title | Refining Procedures within Regulatory Toxicology Studies: Improving Animal Welfare and Data |
title_full | Refining Procedures within Regulatory Toxicology Studies: Improving Animal Welfare and Data |
title_fullStr | Refining Procedures within Regulatory Toxicology Studies: Improving Animal Welfare and Data |
title_full_unstemmed | Refining Procedures within Regulatory Toxicology Studies: Improving Animal Welfare and Data |
title_short | Refining Procedures within Regulatory Toxicology Studies: Improving Animal Welfare and Data |
title_sort | refining procedures within regulatory toxicology studies improving animal welfare and data |
topic | 3Rs fasting metabolism microsampling non-rodents refinements |
url | https://www.mdpi.com/2076-2615/11/11/3057 |
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