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Safety immunopharmacology: Evaluation of the adverse potential of pharmaceuticals on the immune system
The ICH S6R1 and S8 guidelines define a general framework for the immunotoxicity evaluation of biotechnology-derived pharmaceuticals and human pharmaceuticals, respectively. As severe and unpredicted adverse events dramatically showed in the recent years that the immune system is a critical aspect o...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier Inc.
2012
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7111030/ https://www.ncbi.nlm.nih.gov/pubmed/22587937 http://dx.doi.org/10.1016/j.vascn.2012.05.001 |
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author | Descotes, Jacques |
author_facet | Descotes, Jacques |
author_sort | Descotes, Jacques |
collection | PubMed |
description | The ICH S6R1 and S8 guidelines define a general framework for the immunotoxicity evaluation of biotechnology-derived pharmaceuticals and human pharmaceuticals, respectively. As severe and unpredicted adverse events dramatically showed in the recent years that the immune system is a critical aspect of drug safety, this framework needs to be revisited to enhance the prediction of nonclinical immune safety evaluation. Safety immunopharmacology is deemed to contribute to this awaited improvement by enabling early screening of the potential for drug candidates to induce unexpected immunosuppressive and immunostimulatory effects as well as nonimmune-mediated hypersensitivity reactions. Dedicated safety immunopharmacology can also generate mechanistic data to determine which relevant additional immunotoxicity studies should be conducted. Immunological assays and models that can be considered for use in the context of safety pharmacology studies are presented as well as perspectives for their timely development. |
format | Online Article Text |
id | pubmed-7111030 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2012 |
publisher | Elsevier Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-71110302020-04-02 Safety immunopharmacology: Evaluation of the adverse potential of pharmaceuticals on the immune system Descotes, Jacques J Pharmacol Toxicol Methods Article The ICH S6R1 and S8 guidelines define a general framework for the immunotoxicity evaluation of biotechnology-derived pharmaceuticals and human pharmaceuticals, respectively. As severe and unpredicted adverse events dramatically showed in the recent years that the immune system is a critical aspect of drug safety, this framework needs to be revisited to enhance the prediction of nonclinical immune safety evaluation. Safety immunopharmacology is deemed to contribute to this awaited improvement by enabling early screening of the potential for drug candidates to induce unexpected immunosuppressive and immunostimulatory effects as well as nonimmune-mediated hypersensitivity reactions. Dedicated safety immunopharmacology can also generate mechanistic data to determine which relevant additional immunotoxicity studies should be conducted. Immunological assays and models that can be considered for use in the context of safety pharmacology studies are presented as well as perspectives for their timely development. Elsevier Inc. 2012 2012-05-13 /pmc/articles/PMC7111030/ /pubmed/22587937 http://dx.doi.org/10.1016/j.vascn.2012.05.001 Text en Copyright © 2012 Elsevier Inc. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. |
spellingShingle | Article Descotes, Jacques Safety immunopharmacology: Evaluation of the adverse potential of pharmaceuticals on the immune system |
title | Safety immunopharmacology: Evaluation of the adverse potential of pharmaceuticals on the immune system |
title_full | Safety immunopharmacology: Evaluation of the adverse potential of pharmaceuticals on the immune system |
title_fullStr | Safety immunopharmacology: Evaluation of the adverse potential of pharmaceuticals on the immune system |
title_full_unstemmed | Safety immunopharmacology: Evaluation of the adverse potential of pharmaceuticals on the immune system |
title_short | Safety immunopharmacology: Evaluation of the adverse potential of pharmaceuticals on the immune system |
title_sort | safety immunopharmacology: evaluation of the adverse potential of pharmaceuticals on the immune system |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7111030/ https://www.ncbi.nlm.nih.gov/pubmed/22587937 http://dx.doi.org/10.1016/j.vascn.2012.05.001 |
work_keys_str_mv | AT descotesjacques safetyimmunopharmacologyevaluationoftheadversepotentialofpharmaceuticalsontheimmunesystem |