Integrated Testing Strategies (ITS) for safety assessment

Research output: Contribution to journalArticle

Published copy (DOI)

Author(s)

  • 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
  • Donald Prater
  • Pilar Prieto
  • Andreas Schepky
  • Gerrit Schüürmann
  • Lena Smirnova
  • Colleen Toole
  • Erwin van Vliet
  • Dirk Weisensee
  • Thomas Hartung

Department/unit(s)

Publication details

JournalALTEX
DatePublished - 2015
Issue number1
Volume32
Number of pages16
Pages (from-to)25-40
Original languageEnglish

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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