ICCVAM Guidelines for the Nomination and Submission of New, Revised, and Alternative Test Methods

摘要

Before a new or modified test method is used to generate information to support regulatory decisions, it must (a) undergo adequate validation to determine its reliability and accuracy for a specific proposed use, and (b) be deemed acceptable by one or more regulatory agencies to fill a specific need. Criteria for validation and regulatory acceptance have been developed by the U.S. Federal government and are described in the report, Validation and Regulatory Acceptance of Toxicological Test Methods: A Report of the Ad Hoc Interagency Coordinating Committee on the Validation of Alternative Methods. Prior to the initiation of test method development or validation efforts, sponsors should consider these validation and acceptance criteria. The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) developed this document to assist test method sponsors and nominators in organizing the information needed by ICCVAM to assess the validation status of a new or modified test method at any stage of the validation process.