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Toxicity Testing in the 21(st) Century Beyond Environmental Chemicals

After the publication of the report titled Toxicity Testing in the 21(st) Century – A Vision and a Strategy, many initiatives started to foster a major paradigm shift for toxicity testing – from apical endpoints in animal-based tests to mechanistic endpoints through delineation of pathways of toxici...

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Autores principales: Rovida, Costanza, Asakura, Shoji, Daneshian, Mardas, Hofman-Huether, Hana, Leist, Marcel, Meunier, Leo, Reif, David, Rossi, Anna, Schmutz, Markus, Valentin, Jean-Pierre, Zurlo, Joanne, Hartung, Thomas
Formato: Online Artículo Texto
Lenguaje:English
Publicado: 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5986181/
https://www.ncbi.nlm.nih.gov/pubmed/26168280
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author Rovida, Costanza
Asakura, Shoji
Daneshian, Mardas
Hofman-Huether, Hana
Leist, Marcel
Meunier, Leo
Reif, David
Rossi, Anna
Schmutz, Markus
Valentin, Jean-Pierre
Zurlo, Joanne
Hartung, Thomas
author_facet Rovida, Costanza
Asakura, Shoji
Daneshian, Mardas
Hofman-Huether, Hana
Leist, Marcel
Meunier, Leo
Reif, David
Rossi, Anna
Schmutz, Markus
Valentin, Jean-Pierre
Zurlo, Joanne
Hartung, Thomas
author_sort Rovida, Costanza
collection PubMed
description After the publication of the report titled Toxicity Testing in the 21(st) Century – A Vision and a Strategy, many initiatives started to foster a major paradigm shift for toxicity testing – from apical endpoints in animal-based tests to mechanistic endpoints through delineation of pathways of toxicity (PoT) in human cell based systems. The US EPA has funded an important project to develop new high throughput technologies based on human cell based in vitro technologies. These methods are currently being incorporated into the chemical risk assessment process. In the pharmaceutical industry, the efficacy and toxicity of new drugs are evaluated during preclinical investigations that include drug metabolism, pharmacokinetics, pharmacodynamics and safety toxicology studies. The results of these studies are analyzed and extrapolated to predict efficacy and potential adverse effects in humans. However, due to the high failure rate of drugs during the clinical phases, a new approach for a more predictive assessment of drugs both in terms of efficacy and adverse effects is getting urgent. The food industry faces the challenge of assessing novel foods and food ingredients for the general population, while using animal safety testing for extrapolation purposes is often of limited relevance. The question is whether the latest paradigm shift proposed by the Tox21c report for chemicals may provide a useful tool to improve the risk assessment approach also for drugs and food ingredients.
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spelling pubmed-59861812018-06-04 Toxicity Testing in the 21(st) Century Beyond Environmental Chemicals Rovida, Costanza Asakura, Shoji Daneshian, Mardas Hofman-Huether, Hana Leist, Marcel Meunier, Leo Reif, David Rossi, Anna Schmutz, Markus Valentin, Jean-Pierre Zurlo, Joanne Hartung, Thomas ALTEX Article After the publication of the report titled Toxicity Testing in the 21(st) Century – A Vision and a Strategy, many initiatives started to foster a major paradigm shift for toxicity testing – from apical endpoints in animal-based tests to mechanistic endpoints through delineation of pathways of toxicity (PoT) in human cell based systems. The US EPA has funded an important project to develop new high throughput technologies based on human cell based in vitro technologies. These methods are currently being incorporated into the chemical risk assessment process. In the pharmaceutical industry, the efficacy and toxicity of new drugs are evaluated during preclinical investigations that include drug metabolism, pharmacokinetics, pharmacodynamics and safety toxicology studies. The results of these studies are analyzed and extrapolated to predict efficacy and potential adverse effects in humans. However, due to the high failure rate of drugs during the clinical phases, a new approach for a more predictive assessment of drugs both in terms of efficacy and adverse effects is getting urgent. The food industry faces the challenge of assessing novel foods and food ingredients for the general population, while using animal safety testing for extrapolation purposes is often of limited relevance. The question is whether the latest paradigm shift proposed by the Tox21c report for chemicals may provide a useful tool to improve the risk assessment approach also for drugs and food ingredients. 2015 /pmc/articles/PMC5986181/ /pubmed/26168280 Text en http://creativecommons.org/licenses/by/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 International license (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium, provided the original work is appropriately cited.
spellingShingle Article
Rovida, Costanza
Asakura, Shoji
Daneshian, Mardas
Hofman-Huether, Hana
Leist, Marcel
Meunier, Leo
Reif, David
Rossi, Anna
Schmutz, Markus
Valentin, Jean-Pierre
Zurlo, Joanne
Hartung, Thomas
Toxicity Testing in the 21(st) Century Beyond Environmental Chemicals
title Toxicity Testing in the 21(st) Century Beyond Environmental Chemicals
title_full Toxicity Testing in the 21(st) Century Beyond Environmental Chemicals
title_fullStr Toxicity Testing in the 21(st) Century Beyond Environmental Chemicals
title_full_unstemmed Toxicity Testing in the 21(st) Century Beyond Environmental Chemicals
title_short Toxicity Testing in the 21(st) Century Beyond Environmental Chemicals
title_sort toxicity testing in the 21(st) century beyond environmental chemicals
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5986181/
https://www.ncbi.nlm.nih.gov/pubmed/26168280
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