Meeting Report: Validation of Toxicogenomics-Based Test Systems: ECVAM–ICCVAM/NICEATM Considerations for Regulatory Use
نویسندگان
چکیده
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.
منابع مشابه
Internationally harmonized processes for test method evaluation, validation and regulatory acceptance: The role of OECD guidance document 34
Historically, test method evaluation, validation and review processes and criteria have been generally region-specific, often resulting in duplicative efforts and, at times, incongruent conclusions regarding the quality and utility of a test method. In an attempt to standardize such review and evaluation processes so as to render them globally consistent, experts in these arenas from such inter...
متن کاملValidation of the 21 Century Toxicology Toolbox: Challenges, Opportunities, and the Way Forward
Consumers and workers are exposed to a wide range of naturally occurring and manmade chemicals and products in foods, medicines, consumer products, pesticides, water, air, and other sources. Safety testing is required by regulatory authorities to determine if chemicals and products are safe or if they may produce adverse health effects to people, animals, and the environment. Such testing deter...
متن کامل15 Years Out: Reinventing ICCVAM
In 1997, the National Institute of Environmental Health Sciences (NIEHS) established the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), an ad hoc federal inter agency committee to address the growing need for obtaining regu la tory acceptance of new toxicological test methods. The thought was that simultaneous agency evaluation of new methods that address...
متن کاملFirst alternative method validated by a retrospective weight-of-evidence approach to replace the Draize eye test for the identification of non-irritant substances for a defined applicability domain.
A replacement alternative to the rabbit eye irritation test has been sought for many years. First published in 1944 by FDA toxicologist J. H. Draize, the test, now known as the Draize Eye Test, has been used extensively to assess eye safety. It has also been a focal point for concern regarding its animal use. In 1992, Molecular Devices developed the Cytosensor Microphysiometer (CM) technology, ...
متن کاملPhysiologically-based Kinetic Modelling (PBK Modelling): meeting the 3Rs agenda. The report and recommendations of ECVAM Workshop 63.
This is the report of the 63rd of a series of workshops organised by the European Centre for the Validation of Alternative Methods (ECVAM). ECVAM’s main objective, as defined in 1993 by its Scientific Advisory Committee, is to promote the scientific and regulatory acceptance of alternative methods which are relevant to the biosciences and which reduce, refine or replace the use of laboratory an...
متن کامل