Spec. Issue 2006 - Article Summary

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Ensuring quality of in vitro alternative test methods

Amy S. Rispin1 and Katherine Stitzel2
1U.S. Environmental Protection Agency, Office of Pesticide Programs (7506C), Washington, D.C., U.S.A.
2Consultant, West Chester, Ohio, U.S.A.

In vitro and ex vivo methods have been developed or are under development to reduce or replace animal usage in toxicity tests. Consensus is developing in the scientific community on the quality control measures needed for in vitro methods; including appropriate controls, data reporting elements, and benchmarks to be identified in test guidelines so that the potential risks of chemicals can be reviewed and assessed reliably. Consistent with the goal of obtaining scientifically sound test data for hazard and risk assessment of chemicals, changes have been made in current policies and procedures to facilitate the acceptance of data developed using these methods. National and international organisations have developed policies and standards for scientific practice to assure quality in the implementation of in vitro methods. ICCVAM and ECVAM have developed the Performance Standards process to allow proprietary test systems using in vitro/ex vivo methods to be accepted for regulatory use, where Performance Standards include use of reference chemicals, essential test method components and statistical performance results. Additional guidance has been provided for OECD’s Good Laboratory Practice principles which will help to ensure that in vitro tests used for regulatory purposes are reproducible, credible and acceptable. Generic test guidelines incorporating Performance Standards are being written to allow acceptance of proprietary test methods by regulatory agencies and to provide assurance that any in vitro system performs over time in a manner that is consistent with the test system as it was originally validated. Future developments should address standardised data reporting elements for special techniques, such as cell and tissue culture or microarrays.

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