Practical Aspects of Designing and Conducting Validation Studies Involving Multi-study Trials.
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.
European Commission, Joint Research Centre (JRC), Ispra, Italy. Sandra.COECKE@ec.europa.eu.
Sandra
S
Coecke
European Commission, Joint Research Centre (JRC), Ispra, Italy.
Camilla
C
Bernasconi
European Commission, Joint Research Centre (JRC), Ispra, Italy.
Gerard
G
Bowe
European Commission, Joint Research Centre (JRC), Ispra, Italy.
Ann-Charlotte
AC
Bostroem
European Commission, Joint Research Centre (JRC), Ispra, Italy.
Julien
J
Burton
European Commission, Joint Research Centre (JRC), Ispra, Italy.
Thomas
T
Cole
European Commission, Joint Research Centre (JRC), Ispra, Italy.
Salvador
S
Fortaner
European Commission, Joint Research Centre (JRC), Ispra, Italy.
Varvara
V
Gouliarmou
UK GLP Monitoring Authority, MHRA, London, UK.
Andrew
A
Gray
European Commission, Joint Research Centre (JRC), Ispra, Italy.
Claudius
C
Griesinger
Directorate General for Environment, European Commission, Brussels, Belgium.
Susanna
S
Louhimies
European Commission, Joint Research Centre (JRC), Ispra, Italy.
Emilio Mendoza-de
EM
Gyves
European Commission, Joint Research Centre (JRC), Ispra, Italy.
Elisabeth
E
Joossens
Directorate General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission, Brussels, Belgium.
Maurits-Jan
MJ
Prinz
European Commission, Joint Research Centre (JRC), Ispra, Italy.
Anne
A
Milcamps
European Commission, Joint Research Centre (JRC), Ispra, Italy.
Nicholaos
N
Parissis
European Commission, Joint Research Centre (JRC), Ispra, Italy.
Iwona
I
Wilk-Zasadna
European Commission, Joint Research Centre (JRC), Ispra, Italy.
João
J
Barroso
European Commission, Joint Research Centre (JRC), Ispra, Italy.
Bertrand
B
Desprez
European Commission, Joint Research Centre (JRC), Ispra, Italy.
Ingrid
I
Langezaal
European Commission, Joint Research Centre (JRC), Ispra, Italy.
Roman
R
Liska
European Commission, Joint Research Centre (JRC), Ispra, Italy.
Siegfried
S
Morath
European Commission, Joint Research Centre (JRC), Ispra, Italy.
Vittorio
V
Reina
European Commission, Joint Research Centre (JRC), Ispra, Italy.
Chiara
C
Zorzoli
European Commission, Joint Research Centre (JRC), Ispra, Italy.
Valérie
V
Zuang
D000826:Animal Testing Alternatives / Q000379:methods*; D000818:Animals; D005062:European Union; D012107:Research Design; D018675:Toxicity Tests / Q000379:methods*; D054928:Validation Studies as Topic