Validation of Alternative Methods for Toxicity Testing

Sandra Coecke, Camilla Bernasconi, Gerard Bowe, Ann-Charlotte Bostroem, Julien Burton, Thomas Cole, Salvador Fortaner, Varvara Gouliarmou, Andrew Gray, Claudius Griesinger, Susanna Louhimies, Emilio Mendoza-de Gyves, Elisabeth Joossens, Maurits-Jan Prinz, Anne Milcamps, Nicholaos Parissis, Iwona Wilk-Zasadna, João Barroso, Bertrand Desprez, Ingrid Langezaal, Roman Liska, Siegfried Morath, Vittorio Reina, Chiara Zorzoli, Valérie Zuang

Chantra Eskes, Maurice Whelan

This chapter focuses on practical aspects of conducting prospective in vitro validation studies, and in particular, by laboratories that are members of the European Union Network of Laboratories for the Validation of Alternative Methods (EU-NETVAL) that is coordinated by the EU Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM). Prospective validation studies involving EU-NETVAL, comprising a multi-study trial involving several laboratories or "test facilities", typically consist of two main steps: (1) the design of the validation study by EURL ECVAM and (2) the execution of the multi-study trial by a number of qualified laboratories within EU-NETVAL, coordinated and supported by EURL ECVAM. The approach adopted in the conduct of these validation studies adheres to the principles described in the OECD Guidance Document on the Validation and International Acceptance of new or updated test methods for Hazard Assessment No. 34 (OECD 2005). The context and scope of conducting prospective in vitro validation studies is dealt with in Chap. 4 . Here we focus mainly on the processes followed to carry out a prospective validation of in vitro methods involving different laboratories with the ultimate aim of generating a dataset that can support a decision in relation to the possible development of an international test guideline (e.g. by the OECD) or the establishment of performance standards.