2017
DOI: 10.14573/altex.1701031
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The need for strategic development of safety sciences

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Cited by 15 publications
(11 citation statements)
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References 54 publications
(56 reference statements)
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“…Regulatory acceptance is generally considered more likely if the NAM has “relevance,” which means that it can be clearly linked to the regulator's operationalized protection goal, and “reliability,” which can be enhanced by ensuring technical guidance documents are available to regulators. But the adoption of a NAM does not depend solely on its attributes because features of the adopting system, including organizational and institutional factors, also need to be addressed in order to realize a shift toward greater use of NAMs in chemical risk assessment (NTP 2004; ECCC 2016; Busquet and Hartung 2017; ICCVAM 2018; SCESEHD et al 2018; Tickner et al 2018). Furthermore, previous surveys concerning the perceptions of NAMs within the toxicology community have provided a portrait of perceived drivers and obstacles, and demographics tied to the use and level of knowledge about NAMs (Vachon et al 2017; Zaunbrecher et al 2017).…”
Section: Introductionmentioning
confidence: 99%
“…Regulatory acceptance is generally considered more likely if the NAM has “relevance,” which means that it can be clearly linked to the regulator's operationalized protection goal, and “reliability,” which can be enhanced by ensuring technical guidance documents are available to regulators. But the adoption of a NAM does not depend solely on its attributes because features of the adopting system, including organizational and institutional factors, also need to be addressed in order to realize a shift toward greater use of NAMs in chemical risk assessment (NTP 2004; ECCC 2016; Busquet and Hartung 2017; ICCVAM 2018; SCESEHD et al 2018; Tickner et al 2018). Furthermore, previous surveys concerning the perceptions of NAMs within the toxicology community have provided a portrait of perceived drivers and obstacles, and demographics tied to the use and level of knowledge about NAMs (Vachon et al 2017; Zaunbrecher et al 2017).…”
Section: Introductionmentioning
confidence: 99%
“…Interestingly, these large databases also impact on the derivation of thresholds of toxicological concern (TTC) ( Hartung, 2017b ; van Ravenzwaay et al , 2017 ), which might synergize with the in silico approach of a RASAR: the RASAR would prioritize substances from the hazard properties side, while TTC bring in the relevant exposure for the respective toxicological space. This could be an integral part for the strategic development of a new safety sciences paradigm ( Busquet and Hartung, 2017 ).…”
Section: Discussionmentioning
confidence: 99%
“…The free concentration (C f ), also called the unbound concentration (C u = C f ), can be derived from the nominal concentration (C nom ) by multiplying C nom by the fraction unbound (f u ), i.e., the of a potential toxicant via the daily diet. All large-scale NAMbased projects, e.g., SEURAT1, Tox21 and EU-ToxRisk (Gocht et al, 2015;Berggren et al, 2017;Wetmore et al, 2014;Sipes et al, 2017;Siméon et al, 2020;Escher et al, 2019;Krebs et al, 2020;Daneshian et al, 2016;Busquet and Hartung, 2017;Judson et al, 2014;Cote et al, 2016;Kavlock et al, 2018;Graepel et al, 2019) have incorporated an IVIVE procedure to convert free concentrations from NAM to a corresponding external dose. Very sophisticated software has been developed for such purposes.…”
Section: Predicting the Free Compound Fraction (F U ) In Vitromentioning
confidence: 99%