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The role of validation in establishing the scientific credibility of predictive toxicology approaches intended for regulatory application

Abstract: 

New approaches in toxicology based on in vitro methods and computational modelling offer considerable potential to improve the efficiency and effectiveness of chemical hazard and risk assessment in a variety of regulatory contexts. However, this presents challenges both for developers and regulatory assessors because often these two communities do not share the same level of confidence in a new approach. To address this challenge, various assessment frameworks have been developed over the past 20 years with the aim of creating harmonised and systematic approaches for evaluating new methods. These frameworks typically focus on specific methodologies and technologies, which has proven useful for establishing the validity and credibility of individual methods. However, given the increasing need to compare methods and combine their use in integrated assessment strategies, the multiplicity of frameworks is arguably becoming a barrier to their acceptance. In this commentary, we explore the concepts of model validity and credibility, and we illustrate how a set of seven credibility factors provides a method-agnostic means of comparing different kinds of predictive toxicology approaches. It is hoped that this will facilitate communication and cross-disciplinarity among method developers and users, with the ultimate aim of increasing the acceptance and use of predictive approaches in toxicology.