The new paradigm in animal testing – “3Rs alternatives”
Regulatory studies have revolutionised over time. Today, the focus has shifted from animal toxicity testing to non-animal for regulatory safety testing. This move is in line with the international 3Rs (Replacement, Reduction, and Refinement) principle and has also changed the regulator's perspe...
| Main Authors: | , |
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| Format: | Article |
| Language: | English |
| Published: |
Academic Press
2024
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| Online Access: | http://psasir.upm.edu.my/id/eprint/119317/ http://psasir.upm.edu.my/id/eprint/119317/1/119317.pdf |
| _version_ | 1848867933938253824 |
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| author | Wen, Tsin Poh Stanslas, Johnson |
| author_facet | Wen, Tsin Poh Stanslas, Johnson |
| author_sort | Wen, Tsin Poh |
| building | UPM Institutional Repository |
| collection | Online Access |
| description | Regulatory studies have revolutionised over time. Today, the focus has shifted from animal toxicity testing to non-animal for regulatory safety testing. This move is in line with the international 3Rs (Replacement, Reduction, and Refinement) principle and has also changed the regulator's perspective. The 3R principle has stimulated changes in policy, regulations, and new approaches to safety assessment in drug development in many countries. The 3Rs approach has led to the discovery and application of new technologies and more human-relevant in vitro approaches that minimise the use of animals including non-human primates, in research and improve animal welfare. In 2016, the European Medicines Agency published the Guidelines on the principles of regulatory acceptance of 3Rs testing approaches, followed by a conceptual paper in 2023 to align with current 3R standards. Additionally, the United States Food and Drug Administration passed new legislation in 2023 that no longer requires all new human drugs to be tested on animals, which will change the current testing paradigm. This review paper provides the adoption of the 3Rs and the current regulatory perspective regarding their implementation. |
| first_indexed | 2025-11-15T14:44:22Z |
| format | Article |
| id | upm-119317 |
| institution | Universiti Putra Malaysia |
| institution_category | Local University |
| language | English |
| last_indexed | 2025-11-15T14:44:22Z |
| publishDate | 2024 |
| publisher | Academic Press |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | upm-1193172025-08-14T03:11:46Z http://psasir.upm.edu.my/id/eprint/119317/ The new paradigm in animal testing – “3Rs alternatives” Wen, Tsin Poh Stanslas, Johnson Regulatory studies have revolutionised over time. Today, the focus has shifted from animal toxicity testing to non-animal for regulatory safety testing. This move is in line with the international 3Rs (Replacement, Reduction, and Refinement) principle and has also changed the regulator's perspective. The 3R principle has stimulated changes in policy, regulations, and new approaches to safety assessment in drug development in many countries. The 3Rs approach has led to the discovery and application of new technologies and more human-relevant in vitro approaches that minimise the use of animals including non-human primates, in research and improve animal welfare. In 2016, the European Medicines Agency published the Guidelines on the principles of regulatory acceptance of 3Rs testing approaches, followed by a conceptual paper in 2023 to align with current 3R standards. Additionally, the United States Food and Drug Administration passed new legislation in 2023 that no longer requires all new human drugs to be tested on animals, which will change the current testing paradigm. This review paper provides the adoption of the 3Rs and the current regulatory perspective regarding their implementation. Academic Press 2024 Article PeerReviewed text en http://psasir.upm.edu.my/id/eprint/119317/1/119317.pdf Wen, Tsin Poh and Stanslas, Johnson (2024) The new paradigm in animal testing – “3Rs alternatives”. Regulatory Toxicology and Pharmacology, 153. art. no. 105705. pp. 1-17. ISSN 0273-2300; eISSN: 1096-0295 https://linkinghub.elsevier.com/retrieve/pii/S0273230024001466 10.1016/j.yrtph.2024.105705 |
| spellingShingle | Wen, Tsin Poh Stanslas, Johnson The new paradigm in animal testing – “3Rs alternatives” |
| title | The new paradigm in animal testing – “3Rs alternatives” |
| title_full | The new paradigm in animal testing – “3Rs alternatives” |
| title_fullStr | The new paradigm in animal testing – “3Rs alternatives” |
| title_full_unstemmed | The new paradigm in animal testing – “3Rs alternatives” |
| title_short | The new paradigm in animal testing – “3Rs alternatives” |
| title_sort | new paradigm in animal testing – “3rs alternatives” |
| url | http://psasir.upm.edu.my/id/eprint/119317/ http://psasir.upm.edu.my/id/eprint/119317/ http://psasir.upm.edu.my/id/eprint/119317/ http://psasir.upm.edu.my/id/eprint/119317/1/119317.pdf |