Meeting report: Validation of toxicogenomics-based test systems: ECVAM-ICCVAM/NICEATM considerations for regulatory use

Raffaella Corvi, Hans Jürgen Ahr, Sylvio Albertini, David H. Blakey, Libero Clerici, Sandra Coecke, George R. Douglas, Laura Gribaldo, John P. Groten, Bernd Haase, Karen Hamernik, Thomas Hartung, Tohru Inoue, Ian Indans, Daniela Maurici, George Orphanides, Diana Rembges, Susanna Assunta Sansone, Jason R. Snape, Eisaku TodaWeida Tong, Joost H. van Delft, Brenda Weis, Leonard M. Schechtman

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)420-429
Number of pages10
JournalEnvironmental health perspectives
Volume114
Issue number3
DOIs
StatePublished - Mar 2006

Keywords

  • Acceptance
  • Alternatives
  • Biomarker
  • Predictive test
  • Regulatory use
  • Standardization
  • Toxicogenomics
  • Toxicology
  • Validation

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Health, Toxicology and Mutagenesis

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  • Cite this

    Corvi, R., Ahr, H. J., Albertini, S., Blakey, D. H., Clerici, L., Coecke, S., Douglas, G. R., Gribaldo, L., Groten, J. P., Haase, B., Hamernik, K., Hartung, T., Inoue, T., Indans, I., Maurici, D., Orphanides, G., Rembges, D., Sansone, S. A., Snape, J. R., ... Schechtman, L. M. (2006). Meeting report: Validation of toxicogenomics-based test systems: ECVAM-ICCVAM/NICEATM considerations for regulatory use. Environmental health perspectives, 114(3), 420-429. https://doi.org/10.1289/ehp.8247