Evidence-based toxicology for the 21st century: Opportunities and challenges

Stephens, Martin L.; Andersen, Melvin E.; Becker, Richard A.; Betts, Kellyn S.; Boekelheide, Kim; Carney, Ed; Chapin, Robert E.; Devlin, Dennis J.; Fitzpatrick, Suzanne; Fowle, John R.; Harlow, Patricia; Hartung, Thomas; Hoffmann, Sebastian; Holsapple, Michael P.; Jacobs, Abigail; Judson, Richard S.; Naidenko, Olga V.; Pastoor, Tim; Patlewicz, Grace; Rowan, Andrew N.; Scherer, Roberta W.; Shaikh, Rashid; Simon, Timothy M.; Wolf, Douglas C.; Zurlo, Joanne

doi:10.14573/altex.2013.1.074

Cited by 44 publications

(33 citation statements)

References 31 publications

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“…Methods suggested by the evidence-based toxicology Collaboration (european and US branches, http:// www.ebtox.com) will be helpful in this process (Stephens et al, 2013). The risk classification itself is also likely to undergo fundamental changes.…”

Section: General Forward Strategiesmentioning

confidence: 99%

Consensus report on the future of animal-free systemic toxicity testing

Leist

2014

ALTEX

136

117

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Section: General Forward Strategiesmentioning

confidence: 99%

Consensus report on the future of animal-free systemic toxicity testing

Leist

2014

ALTEX

136

117

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“…Due to frequent differences in opinion, expert based approaches are challenged with subjectivity, lack of consistency and transparency [12] and prefer to err on the conservative side when in doubt, or when conflicting information is available as evidence. To make the situation even more challenging for the traditional expert-based evaluations, as mentioned earlier, the amount of available alternative assay data is increasing rapidly and becoming more diverse.…”

Section: Its Approaches State Of the Artmentioning

confidence: 99%

Integrated Testing Strategies for Skin Sensitization Hazard and Potency Assessment—State of the Art and Challenges

Jaworska

2016

Cosmetics

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Abstract:The paper provides an overview of existing Integrated Testing Strategies (ITS) for assessing hazard and potency of skin sensitization. The ITS research is active, diverse and constantly evolving as new assays are being developed and new mechanistic insights are discovered. Despite the need to assess potency, the majority of the ITS approaches developed to date assess hazard only. Reasons for this situation are analyzed and include, for example, the dynamic range of existing alternative assays versus the range of in vivo responses, but also sporadic use of kinetic information and molar units. Depending on the application, regulatory or product development, standardized and nonstandard ITS approaches will be developed. Challenges to practical applications, with focus on regulatory are discussed.

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“…However, no formal validations (Leist et al, 2012) have yet been undertaken. Both, validation of high-throughput methods (Judson et al, 2013) for the multitude of flavor chemicals, systematic reviews (Hartung and Hoffmann, 2009;Hoffmann et al, 2014;Stephens, 2013Stephens, , 2016, and mechanistic validation of in vitro models (Hartung et al, 2013b) will need to be considered.…”

Section: Testing Challengesmentioning

confidence: 99%