Meeting report: Validation of toxicogenomics-based test systems: ECVAM-ICCVAM/NICEATM considerations for regulatory use.
This is the report of the first workshop "Validation of Toxicogenomics-Based Test Systems" held 11-12 December 2003 in Ispra, Italy. The workshop was hosted by the European Centre for the Validation of Alternative Methods (ECVAM) and organized jointly by ECVAM, the U.S. Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), and the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM). The primary aim of the workshop was for participants to discuss and define principles applicable to the validation of toxicogenomics platforms as well as validation of specific toxicologic test methods that incorporate toxicogenomics technologies. The workshop was viewed as an opportunity for initiating a dialogue between technologic experts, regulators, and the principal validation bodies and for identifying those factors to which the validation process would be applicable. It was felt that to do so now, as the technology is evolving and associated challenges are identified, would be a basis for the future validation of the technology when it reaches the appropriate stage. Because of the complexity of the issue, different aspects of the validation of toxicogenomics-based test methods were covered. The three focus areas include a) biologic validation of toxicogenomics-based test methods for regulatory decision making, b) technical and bioinformatics aspects related to validation, and c) validation issues as they relate to regulatory acceptance and use of toxicogenomics-based test methods. In this report we summarize the discussions and describe in detail the recommendations for future direction and priorities.
Corvi
Raffaella
R
European Centre for the Validation of Alternative Methods, Institute for Health and Consumer Protection, Joint Research Centre of the European Commission, Ispra, Italy. raffaella.corvi@jrc.it
Ahr
Hans-Jürgen
HJ
Albertini
Silvio
S
Blakey
David H
DH
Clerici
Libero
L
Coecke
Sandra
S
Douglas
George R
GR
Gribaldo
Laura
L
Groten
John P
JP
Haase
Bernd
B
Hamernik
Karen
K
Hartung
Thomas
T
Inoue
Tohru
T
Indans
Ian
I
Maurici
Daniela
D
Orphanides
George
G
Rembges
Diana
D
Sansone
Susanna-Assunta
SA
Snape
Jason R
JR
Toda
Eisaku
E
Tong
Weida
W
van Delft
Joost H
JH
Weis
Brenda
B
Schechtman
Leonard M
LM
D000826:Animal Testing Alternatives / Q000331:legislation & jurisprudence; D019295:Computational Biology; D033161:Government Regulation; D015203:Reproducibility of Results; D018675:Toxicity Tests / Q000379:methods; D043922:Toxicogenetics / Q000331:legislation & jurisprudence*