Spec. Issue 2006 - Article Summary

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Streamlining the validation process: The ICCVAM nomination and submission process and guidelines for new, revised and alternative test methods

Leonard M. Schechtman1, Marilyn L. Wind2 and William S. Stokes3
1U.S. FDA, National Center for Toxicological Research, Rockville, Maryland, USA; 2U.S. Consumer Product Safety
Commission, Bethesda, Maryland, USA; 3NIEHS, Interagency Center for the Evaluation of Alternative Toxicological Methods,
Research Triangle Park, North Carolina, USA

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) has developed and implemented a process for the nomination and submission of test methods and for their prioritisation for review and evaluation. Prioritisation of proposed test methods is a function of their regulatory applicability, anticipated multi-agency interest and use, responsiveness to the replacement, reduction, and refinement of animal use, potential for improved predictivity of adverse effects relative to currently employed methods, and efficiency and economic savings. The newly revised ICCVAM Guidelines for the Nomination and Submission of New, Revised, and Alternative Test Methods (http://iccvam.niehs.nih.gov/docs/guidelines/subguide.htm) were developed to assist test method sponsors/nominators in organising the information needed to assess the validation status of test methods at any stage of the validation process and the extent to which the ICCVAM validation and acceptance criteria have been or will be addressed. The
original guidelines, in use since 1998 to evaluate the scientific validity of test methods that have since achieved regulatory acceptance, have been updated to reflect experience gained and to help to facilitate a more efficient process. Adherence to these revised guidelines will help ensure the sufficiency of data and information for independent peer review and for regulatory authorities to determine the scientific validity and regulatory acceptability of test methods. The elements comprising these guidelines have now been incorporated into international guidance for the evaluation of methods proposed for new test guidelines. The ICCVAM nomination, submission and prioritisation process and the content and organisation of submissions or nominations are described.

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