Spec. Issue 2006 - Article Summary

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The use of test method performance standards to streamline the validation process

William S. Stokes1, Leonard M. Schechtman2, Amy Rispin3, Kailash Gupta4, Karen Hamernik3,
Raymond Tice1 and Marilyn Wind4

1National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods, National Institute
of Environmental Health Sciences, NIH, DHHS, Research Triangle Park, NC, USA; 2US Food and Drug Administration, National
Center for Toxicological Research, Rockville, MD, USA; 3U. S. Environmental Protection Agency, Washington, DC, USA;
4Consumer Product Safety Commission, Bethesda, MD, USA

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) recently defined and established a process for the development and use of test method performance standards. Performance standards communicate the basis by which proprietary and non-proprietary test methods have been determined to be acceptable for proposed specific testing uses. They also provide the basis for evaluating the acceptability of proposed test methods that are structurally and functionally similar to an accepted test method. The development and use of test method performance standards is expected to streamline the validation and regulatory acceptance of new, revised and alternative test methods.

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