title: Meeting report: Validation of toxicogenomics-based test systems: ECVAM-ICCVAM/NICEATM considerations for regulatory use.
abstract: 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.
authors.affiliation: 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
authors.forename: Raffaella
authors.initials: R
authors.lastname: Corvi
authors.forename: Hans-Jürgen
authors.initials: HJ
authors.lastname: Ahr
authors.forename: Silvio
authors.initials: S
authors.lastname: Albertini
authors.forename: David H
authors.initials: DH
authors.lastname: Blakey
authors.forename: Libero
authors.initials: L
authors.lastname: Clerici
authors.forename: Sandra
authors.initials: S
authors.lastname: Coecke
authors.forename: George R
authors.initials: GR
authors.lastname: Douglas
authors.forename: Laura
authors.initials: L
authors.lastname: Gribaldo
authors.forename: John P
authors.initials: JP
authors.lastname: Groten
authors.forename: Bernd
authors.initials: B
authors.lastname: Haase
authors.forename: Karen
authors.initials: K
authors.lastname: Hamernik
authors.forename: Thomas
authors.initials: T
authors.lastname: Hartung
authors.forename: Tohru
authors.initials: T
authors.lastname: Inoue
authors.forename: Ian
authors.initials: I
authors.lastname: Indans
authors.forename: Daniela
authors.initials: D
authors.lastname: Maurici
authors.forename: George
authors.initials: G
authors.lastname: Orphanides
authors.forename: Diana
authors.initials: D
authors.lastname: Rembges
authors.forename: Susanna-Assunta
authors.initials: SA
authors.lastname: Sansone
authors.forename: Jason R
authors.initials: JR
authors.lastname: Snape
authors.forename: Eisaku
authors.initials: E
authors.lastname: Toda
authors.forename: Weida
authors.initials: W
authors.lastname: Tong
authors.forename: Joost H
authors.initials: JH
authors.lastname: van Delft
authors.forename: Brenda
authors.initials: B
authors.lastname: Weis
authors.forename: Leonard M
authors.initials: LM
authors.lastname: Schechtman
mesh_terms: 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*