Items related to Validation of Alternative Methods for Toxicity Testing
Synopsis
Introduction.- Validation in support of internationally harmonised OECD Test Guidelines for assessing the safety of chemicals.- Regulatory acceptance of alternative methods in the development and approval of pharmaceuticals.- Validation of alternative in vitro methods to animal testing: concepts, challenges, processes and tools.- Practical aspects of designing and conducting validation studies involving multi-study trials.- Validation of computational methods.- Implementation of New Test Methods into Practical Testing.- Pathway Based Toxicology and Fit-for-Purpose Assays.- Evidence-based toxicology.- Validation of transcriptomics-based in vitro methods.- Ensuring the quality of stem cell-derived in vitro models for toxicity testing.- Validation of bioreactor and human-on-a-chip devices for chemical safety assessment.- Integrated approaches to testing and assessment.- International harmonization and cooperation in the validation of alternative methods.- Evolving the principles and practice of validation for new alternative approaches to toxicity testing.
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