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A roadmap for the development of alternative (non-animal) methods for systemic toxicity testing.
Systemic toxicity testing forms the cornerstone for the safety evaluation of substances. Pressures to move from traditional animal models to novel technologies arise from various concerns, including:… Expand
Biology-inspired microphysiological system approaches to solve the prediction dilemma of substance testing.
The recent advent of microphysiological systems - microfluidic biomimetic devices that aspire to emulate the biology of human tissues, organs and circulation in vitro - is envisaged to enable a global paradigm shift in drug development. Expand
Metabolomics in toxicology and preclinical research.
Metabolomics, the comprehensive analysis of metabolites in a biological system, provides detailed information about the biochemical/physiological status of a biological system, and about the changes… Expand
Integrated Testing Strategies (ITS) for safety assessment.
Integrated testing strategies (ITS), as opposed to single definitive tests or fixed batteries, are expected to efficiently combine different information sources in a quantifiable fashion to satisfy an information need, in this case for regulatory safety assessments. Expand
Reference compounds for alternative test methods to indicate developmental neurotoxicity (DNT) potential of chemicals: example lists and criteria for their selection and use
We present the first generation of alternative DNT tests that target the modulation of fundamental neurodevelopmental processes (such as neuronal differentiation, precursor cell migration or neuronal network formation) by chemicals, and provide recommendations on how to use them. Expand
Toxicity Testing in the 21st Century Beyond Environmental Chemicals
Summary 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 –… Expand
Assessment of pyrogenic contaminations with validated human whole-blood assay
We present an internationally validated protocol for the evaluation of pyrogenic contaminations using human whole blood. In the in vitro pyrogen test (IPT) the sample is incubated with fresh or… Expand
The use of biomarkers of toxicity for integrating in vitro hazard estimates into risk assessment for humans.
This report presents the results of a workshop aimed at better defining the use of in vitro-derived biomarkers of toxicity (BoT) and determining the place these data can have in human risk assessment. Expand
Validation and quality control of replacement alternatives - Current status and future challenges
We describe here the principles of model development and quality control. Expand
Consensus report on the future of animal-free systemic toxicity testing.
Since March 2013, animal use for cosmetics testing for the European market has been banned. This requires a renewed view on risk assessment in this field. However, in other fields as well,… Expand