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|Title:||Validation of Toxicogenomics-Based Test Systems:ECVAM-ICCVAM/NICEATM Considerations for Regulatory Use|
|Authors:||CORVI RAFFAELLA; AHR Hans; ALBERTINI Silvio; BLAKEY David; CLERICI Libero; COECKE SANDRA; DOUGLAS George; GRIBALDO LAURA; GROTEN John; HAASE Bernd; HAMERNIK Karen; HARTUNG THOMAS; INOUE Tohru; INDANS Ian; MAURICI Daniela; ORPHANIDES George; REMBGES DIANA; SANSONE Susanna; SNAPE Jason; TODA Eisaku; TONG Weida; VAN DELFT Joost; WEIS Brenda; SCHECHTMAN Leonard|
|Citation:||ENVIRONMENTAL HEALTH PERSPECTIVES vol. 114 no. 2 p. 420-429|
|Publisher:||US DEPT HEALTH HUMAN SERVICES PUBLIC HEALTH SERVICE|
|Type:||Articles in periodicals and books|
|Abstract:||This is the report of the first workshop on the Validation of Toxicogenomics-based Test Systems held in Ispra, Italy on 11-12 December 2003. 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 to discuss and define principles applicable to the validation of toxicogenomics platforms as well as validation of specific toxicological test methods that incorporate toxicogenomics technologies. The workshop was viewed as an opportunity for initiating a dialogue between technological 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 serve as the basis for the future validation of the technology when it reached the appropriate stage. Due to the complexity of the issue, different aspects of the validation of toxicogenomics-based test methods were covered. The three focus areas included (a) biological 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 utilization of toxicogenomics-based test methods. This report summarizes the discussions and details the recommendations for future direction and priorities.|
|JRC Institute:||Institute for Health and Consumer Protection|
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