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Justification for species selection for pharmaceutical toxicity studies
Toxicity studies using mammalian species are generally required to provide safety data to support clinical development and licencing registration for potential new pharmaceuticals. International regulatory guidelines outline recommendations for the order (rodent and/or non-rodent) and number of spec...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7786171/ https://www.ncbi.nlm.nih.gov/pubmed/33442468 http://dx.doi.org/10.1093/toxres/tfaa081 |
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author | Prior, Helen Haworth, Richard Labram, Briony Roberts, Ruth Wolfreys, Alison Sewell, Fiona |
author_facet | Prior, Helen Haworth, Richard Labram, Briony Roberts, Ruth Wolfreys, Alison Sewell, Fiona |
author_sort | Prior, Helen |
collection | PubMed |
description | Toxicity studies using mammalian species are generally required to provide safety data to support clinical development and licencing registration for potential new pharmaceuticals. International regulatory guidelines outline recommendations for the order (rodent and/or non-rodent) and number of species, retaining flexibility for development of a diverse range of drug modalities in a manner relevant for each specific new medicine. Selection of the appropriate toxicology species involves consideration of scientific, ethical and practical factors, with individual companies likely having different perspectives and preferences regarding weighting of various aspects dependent upon molecule characteristics and previous experience of specific targets or molecule classes. This article summarizes presentations from a symposium at the 2019 Annual Congress of the British Toxicology Society on the topic of species selection for pharmaceutical toxicity studies. This symposium included an overview of results from a National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) and Association of British Pharmaceutical Industry (ABPI) international collaboration that reviewed the use of one or two species in regulatory toxicology studies and justification for the species selected within each programme. Perspectives from two pharmaceutical companies described their processes for species selection for evaluation of biologics, and justification for selection of the minipig as a toxicological species for small molecules. This article summarizes discussions on the scientific justification and other considerations taken into account to ensure the most appropriate animal species are used for toxicity studies to meet regulatory requirements and to provide the most value for informing project decisions. |
format | Online Article Text |
id | pubmed-7786171 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-77861712021-01-12 Justification for species selection for pharmaceutical toxicity studies Prior, Helen Haworth, Richard Labram, Briony Roberts, Ruth Wolfreys, Alison Sewell, Fiona Toxicol Res (Camb) Paper Toxicity studies using mammalian species are generally required to provide safety data to support clinical development and licencing registration for potential new pharmaceuticals. International regulatory guidelines outline recommendations for the order (rodent and/or non-rodent) and number of species, retaining flexibility for development of a diverse range of drug modalities in a manner relevant for each specific new medicine. Selection of the appropriate toxicology species involves consideration of scientific, ethical and practical factors, with individual companies likely having different perspectives and preferences regarding weighting of various aspects dependent upon molecule characteristics and previous experience of specific targets or molecule classes. This article summarizes presentations from a symposium at the 2019 Annual Congress of the British Toxicology Society on the topic of species selection for pharmaceutical toxicity studies. This symposium included an overview of results from a National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) and Association of British Pharmaceutical Industry (ABPI) international collaboration that reviewed the use of one or two species in regulatory toxicology studies and justification for the species selected within each programme. Perspectives from two pharmaceutical companies described their processes for species selection for evaluation of biologics, and justification for selection of the minipig as a toxicological species for small molecules. This article summarizes discussions on the scientific justification and other considerations taken into account to ensure the most appropriate animal species are used for toxicity studies to meet regulatory requirements and to provide the most value for informing project decisions. Oxford University Press 2020-11-24 /pmc/articles/PMC7786171/ /pubmed/33442468 http://dx.doi.org/10.1093/toxres/tfaa081 Text en © The Author(s) 2020. Published by Oxford University Press. http://creativecommons.org/licenses/by/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Paper Prior, Helen Haworth, Richard Labram, Briony Roberts, Ruth Wolfreys, Alison Sewell, Fiona Justification for species selection for pharmaceutical toxicity studies |
title | Justification for species selection for pharmaceutical toxicity studies |
title_full | Justification for species selection for pharmaceutical toxicity studies |
title_fullStr | Justification for species selection for pharmaceutical toxicity studies |
title_full_unstemmed | Justification for species selection for pharmaceutical toxicity studies |
title_short | Justification for species selection for pharmaceutical toxicity studies |
title_sort | justification for species selection for pharmaceutical toxicity studies |
topic | Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7786171/ https://www.ncbi.nlm.nih.gov/pubmed/33442468 http://dx.doi.org/10.1093/toxres/tfaa081 |
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