Integrated Testing Strategies (ITS) for safety assessment

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

doi:10.14573/altex.1411011

Integrated Testing Strategies (ITS) for safety assessment

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 LalkoRobert 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

Research output: Contribution to journal › Article › peer-review

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".

Original language	English
Pages (from-to)	25-40
Number of pages	16
Journal	ALTEX
Volume	32
Issue number	1
DOIs	https://doi.org/10.14573/altex.1411011
Publication status	Published - 2015

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10.14573/altex.1411011

Cite this

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., ... Hartung, T. (2015). Integrated Testing Strategies (ITS) for safety assessment. ALTEX, 32(1), 25-40. https://doi.org/10.14573/altex.1411011

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title = "Integrated Testing Strategies (ITS) for safety assessment",

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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year = "2015",

doi = "10.14573/altex.1411011",

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Rovida, C, Alépée, N, Api, AM, Basketter, DA, Bois, FY, Caloni, F, Corsini, E, Daneshian, M, Eskes, C, Ezendam, J, Fuchs, H, Hayden, P, Hegele-Hartung, C, Hoffmann, S, Hubesch, B, Jacobs, MN, Jaworska, J, Kleensang, A, Kleinstreuer, N, Lalko, J, Landsiedel, R, Lebreux, F, Luechtefeld, T, Locatelli, M, Mehling, A, Natsch, A, Pitchford, JW, Prater, D, Prieto, P, Schepky, A, Schüürmann, G, Smirnova, L, Toole, C, van Vliet, E, Weisensee, D & Hartung, T 2015, 'Integrated Testing Strategies (ITS) for safety assessment', ALTEX, vol. 32, no. 1, pp. 25-40. https://doi.org/10.14573/altex.1411011

TY - JOUR

T1 - Integrated Testing Strategies (ITS) for safety assessment

AU - Rovida, Costanza

AU - Alépée, Nathalie

AU - Api, Anne M

AU - Basketter, David A

AU - Bois, Frédéric Y

AU - Caloni, Francesca

AU - Corsini, Emanuela

AU - Daneshian, Mardas

AU - Eskes, Chantra

AU - Ezendam, Janine

AU - Fuchs, Horst

AU - Hayden, Patrick

AU - Hegele-Hartung, Christa

AU - Hoffmann, Sebastian

AU - Hubesch, Bruno

AU - Jacobs, Miriam N

AU - Jaworska, Joanna

AU - Kleensang, André

AU - Kleinstreuer, Nicole

AU - Lalko, Jon

AU - Landsiedel, Robert

AU - Lebreux, Frédéric

AU - Luechtefeld, Thomas

AU - Locatelli, Monica

AU - Mehling, Annette

AU - Natsch, Andreas

AU - Pitchford, Jonathan W

AU - Prater, Donald

AU - Prieto, Pilar

AU - Schepky, Andreas

AU - Schüürmann, Gerrit

AU - Smirnova, Lena

AU - Toole, Colleen

AU - van Vliet, Erwin

AU - Weisensee, Dirk

AU - Hartung, Thomas

PY - 2015

Y1 - 2015

N2 - 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".

AB - 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".

U2 - 10.14573/altex.1411011

DO - 10.14573/altex.1411011

M3 - Article

C2 - 25413849

SN - 1868-596X

VL - 32

SP - 25

EP - 40

JO - ALTEX

JF - ALTEX

IS - 1

ER -