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Integrated Testing Strategies (ITS) for safety assessment.

Costanza Rovida 1 Nathalie Alépée 2 Anne M Api 3 David A Basketter 3 Frédéric y Bois 4 Francesca Caloni 5 Emanuela Corsini 5 Mardas Daneshian 1 Chantra Eskes 6 Janine Ezendam 7 Horst Fuchs 8 Patrick Hayden 9 Christa Hegele-Hartung 10 Sebastian Hoffmann 11 Bruno Hubesch 12 Miriam N Jacobs 13 Joanna Jaworska 14 André Kleensang 15 Nicole Kleinstreuer 16 Jon Lalko 3 Robert Landsiedel 10 Frédéric Lebreux 17 Thomas Luechtefeld 15 Monica Locatelli 18 Annette Mehling 10 Andreas Natsch 19 Jonathan W Pitchford 20 Donald Prater 21 Pilar Prieto 22 Andreas Schepky 23 Gerrit Schüürmann 24 Lena Smirnova 15 Colleen Toole 25 Erwin van Vliet 26 Dirk Weisensee 27 Thomas Hartung 15 
Abstract : Integrated testing strategies (ITS), as opposed to single definitive tests or fixed batteries of tests, are expected to efficiently combine different information sources in a quantifiable fashion to satisfy an information need, in this case for regulatory safety assessments. With increasing awareness of the limitations of each individual tool and the development of highly targeted tests and predictions, the need for combining pieces of evidence increases. The discussions that took place during this workshop, which brought together a group of experts coming from different related areas, illustrate the current state of the art of ITS, as well as promising developments and identifiable challenges. The case of skin sensitization was taken as an example to understand how possible ITS can be constructed, optimized and validated. This will require embracing and developing new concepts such as adverse outcome pathways (AOP), advanced statistical learning algorithms and machine learning, mechanistic validation and "Good ITS Practices".
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Submitted on : Sunday, March 8, 2015 - 10:16:17 AM
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Costanza Rovida, Nathalie Alépée, Anne M Api, David A Basketter, Frédéric y Bois, et al.. Integrated Testing Strategies (ITS) for safety assessment.. ALTEX - Alternatives to Animal Experimentations, 2015, 32 (1), pp.25-40. ⟨10.14573/altex.1411011⟩. ⟨hal-01127740⟩



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