Journal article
Workshop on acceleration of the validation and regulatory acceptance of alternative methods and implementation of testing strategies
National Institute of Public Health and the Environment1
Copenhagen Center for Health Technology, Centers, Technical University of Denmark2
National Food Institute, Technical University of Denmark3
Research Group for Molecular and Reproductive Toxicology, National Food Institute, Technical University of Denmark4
Utrecht University5
Federal Institute for Risk Assessment6
European Chemicals Agency7
Cosmetics Europe – The Personal Care Association8
BASF9
European Commission Joint Research Centre Institute10
Vrije Universiteit Brussel11
Services and Consultation on Alternative Methods12
...and 2 moreThis report describes the proceedings of the BfR-RIVM workshop on validation of alternative methods which was held 23 and 24 March 2017 in Berlin, Germany. Stakeholders from governmental agencies, regulatory authorities, universities, industry and the OECD were invited to discuss current problems concerning the regulatory acceptance and implementation of alternative test methods and testing strategies, with the aim to develop feasible solutions.
Classical validation of alternative methods usually involves one to one comparison with the gold standard animal study. This approach suffers from the reductionist nature of an alternative test as compared to the animal study as well as from the animal study being considered as the gold standard. Modern approaches combine individual alternatives into testing strategies, for which integrated and defined approaches are emerging at OECD.
Furthermore, progress in mechanistic toxicology, e.g. through the adverse outcome pathway approach, and in computational systems toxicology allows integration of alternative test battery results into toxicity predictions that are more fine-tuned to the human situation. The road towards transition to a mechanistically-based human-focused hazard and risk assessment of chemicals requires an open mind towards stepping away from the animal study as the gold standard and defining human biologically based regulatory requirements for human hazard and risk assessment.
Language: | English |
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Publisher: | Elsevier BV |
Year: | 2018 |
Pages: | 62-74 |
ISSN: | 18793177 and 08872333 |
Types: | Journal article |
DOI: | 10.1016/j.tiv.2018.02.018 |
ORCIDs: | Vinggaard, Anne Marie |