Titlebook: Validation of Alternative Methods for Toxicity Testing; Chantra Eskes,Maurice Whelan Book 2016 The Editor(s) (if applicable) and The Autho

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Validation of Computational Methods,oses. We outline how chemical categories are derived to facilitate endpoint specific read-across using tools such as the OECD QSAR Toolbox and discuss some of the current difficulties in addressing the residual uncertainties of read-across. Finally we put forward a perspective of how non-testing app

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Implementation of New Test Methods into Practical Testing,rs are eventually validated for regulatory use. However, for a new test method to be firmly adopted by industry it must be readily available, generally through an in-house industry laboratory, an academic laboratory, or a contract research organization. Regardless of the type of laboratory which int

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Evidence-Based Toxicology,ell as based on parallels between the evaluation of test methods in toxicology and evidence-based assessment of diagnostics tests in medicine. The role model of evidence-based medicine (EBM) motivated both proposals and guided the evolution of EBT, whereas especially systematic reviews and evidence

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Validation of Transcriptomics-Based , Methods,lar changes underlying the adverse effects of a given compound, but also to understand its Mode of Action (MoA). However, the implementation of transcriptomics-based tests within the regulatory arena is not a straightforward process. One of the major obstacles in their regulatory implementation is s

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Ensuring the Quality of Stem Cell-Derived , Models for Toxicity Testing,ew drugs or constituents of new consumer products. This chapter explores the key scientific and ethical criteria that must be addressed at the earliest stages of developing toxicology assays based on human pluripotent stem cell (hPSC) lines. It also identifies key considerations for such assays to b

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Validation of Bioreactor and Human-on-a-Chip Devices for Chemical Safety Assessment, tasks with only a few successful examples so far. The hurdles seem to increase with the growing complexity of the biological systems, emulated by the respective models. Controlled single tissue or organ culture in bioreactors improves the organ-specific functions and maintains their phenotypic stab

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Integrated Approaches to Testing and Assessment, by toxicity testing methods, thereby serving as flexible and suitable tools for toxicological decision making in the twenty-first century. In addition to traditional . and . testing methods, IATA are increasingly incorporating newly developed . systems and measurement technologies such as high thro