Title: Chapter 5: Practical Aspects of Designing and Conducting Validation Studies Involving Multi-Study Trials
Authors: COECKE SandraBERNASCONI CamillaBOWE GerardBOSTROEM Ann-CharlotteBURTON JULIENCOLE ThomasFORTANER TORRENT SalvadorGOULIARMOU VARVARAGRAY AndrewGRIESINGER ClaudiusLOUHIMIES SusannaMENDOZA EMILIOJOOSSENS ELISABETHPRINZ Maurits-JanMILCAMPS AnnePARISSIS NIKOLAOSWILK-ZASADNA IWONAVIEGAS BARROSO JOAO FILIPEDESPREZ BERTRANDLANGEZAAL IngridLISKA RomanMORATH SiegfriedREINA VittorioZORZOLI MARIA CHIARAZUANG Valerie
Publisher: Springer
Publication Year: 2016
JRC N°: JRC93902
ISBN: 978-3-319-33824-8
ISSN: 0065-2598
URI: http://www.springer.com/series/5584
http://publications.jrc.ec.europa.eu/repository/handle/JRC93902
DOI: 10.1007/978-3-319-33826-2
10.1007/978-3-319-33826-2_5
Type: Articles in periodicals and books
Abstract: 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.
JRC Directorate:Health, Consumers and Reference Materials

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