TY - JOUR
T1 - Food for Thought...
T2 - Toxicity testing in the 21st century beyond environmental chemicals
AU - Rovida, Costanza
AU - Asakura, Shoji
AU - Daneshian, Mardas
AU - Hofman-Huether, Hana
AU - Leist, Marcel
AU - Meunier, Leo
AU - Reif, David
AU - Rossi, Anna
AU - Schmutz, Markus
AU - Valentin, Jean Pierre
AU - Zurlo, Joanne
AU - Hartung, Thomas
PY - 2015
Y1 - 2015
N2 - After the publication of the report titled Toxicity Testing in the 21st 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.
AB - After the publication of the report titled Toxicity Testing in the 21st 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.
KW - Drugs
KW - Food ingredients
KW - Safety assessment
KW - Tox21c
UR - http://www.scopus.com/inward/record.url?scp=84938603406&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84938603406&partnerID=8YFLogxK
U2 - 10.14573/altex.1506201
DO - 10.14573/altex.1506201
M3 - Article
C2 - 26168280
AN - SCOPUS:84938603406
SN - 1868-596X
VL - 32
SP - 171
EP - 181
JO - ALTEX
JF - ALTEX
IS - 3
ER -