Integrated testing strategies (ITS) for safety assessment

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Costanza Rovida
Nathalie Alépée
Anne M. Api
David A. Basketter
Frédéric Y. Bois
Francesca Caloni
Emanuela Corsini
Mardas Daneshian
Chantra Eskes
Janine Ezendam
Horst Fuchs
Patrick Hayden
Christa Hegele-Hartung
Sebastian Hoffmann
Bruno Hubesch
Miriam N. Jacobs
Joanna Jaworska
André Kleensang
Nicole Kleinstreuer
Jon Lalko
Robert Landsiedel
Frédéric Lebreux
Thomas Luechtefeld
Monica Locatelli
Annette Mehling
Andreas Natsch
Jonathan W. Pitchford
Donald Prater
Pilar Prieto
Andreas Schepky
Gerrit Schüürmann
Lena Smirnova
Colleen Toole
Erwin van Vliet
Dirk Weisensee
Thomas Hartung


Integrated testing strategies (ITS), as opposed to a single definitive test 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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How to Cite
Rovida, C., Alépée, N., Api, A. M., Basketter, D. A., Bois, F. Y., Caloni, F., Corsini, E., Daneshian, M., Eskes, C., Ezendam, J., Fuchs, H., Hayden, P., Hegele-Hartung, C., Hoffmann, S., Hubesch, B., Jacobs, M. N., Jaworska, J., Kleensang, A., Kleinstreuer, N., Lalko, J., Landsiedel, R., Lebreux, F., Luechtefeld, T., Locatelli, M., Mehling, A., Natsch, A., Pitchford, J. W., Prater, D., Prieto, P., Schepky, A., Schüürmann, G., Smirnova, L., Toole, C., van Vliet, E., Weisensee, D. and Hartung, T. (2015) “Integrated testing strategies (ITS) for safety assessment”, ALTEX - Alternatives to animal experimentation, 32(1), pp. 25–40. doi: 10.14573/altex.1411011.

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