tempting to coordinate standards with the relevant European and Asian regulatory agencies.

  • A well-annotated, freely accessible, database providing access to high-quality “-omic” data.


The following specific actions are recommended to facilitate technical validation of toxicogenomic technologies:

  1. Develop objective standards for assessing sample and data quality from different technology platforms, including standardized materials such as those developed by the ERCC.

  2. Develop appropriate criteria for using toxicogenomic technologies for different applications, such as hazard screening and exposure assessment.

  3. Regulatory agencies should establish clear, transparent, and flexible criteria for the regulatory validation of toxicogenomic technologies. Whereas the use of toxicogenomic data will be facilitated by harmonization of data and method validation criteria among U.S. regulatory agencies and at the international level, harmonization should be a long-term goal and should not prevent individual agencies from developing their own validation procedures and criteria in the shorter term.

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