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How Much Flexibility is Possible When Validating New In Vivo and In Vitro Toxicity Test Methods?

How Much Flexibility is Possible When Validating New In Vivo and In Vitro Toxicity Test Methods? ATLA 31, 225–232, 2003 225 Editorial How Much Flexibility is Possible When Validating New In Vivo and In Vitro Toxicity Test Methods? validated serendipitously via the hazard data that Introduction they have generated, and by establishment of their reliability as a result of their use in various labora- tories. Validation Validation involves assessing the reliability and rele- Objectives vance of a test method for a specific purpose. The need to validate a test method can arise from its pos- The purpose of this editorial is to discuss the ways sible use in-house, or its proposed adoption to gener- in which new in vitro and in vivo methods should be ate data to be submitted to regulatory authorities. Validation for regulatory use is a more complex developed, validated and accepted for regulatory use, especially in relation to the Organisation for process (usually involving formal interlaboratory Economic Cooperation and Development (OECD) studies) than that for in-house application. It is the former type of validation that is the subject of this test guidelines, in the light of the overall process of validation, the criteria for which have been agreed editorial. internationally in recent years. Lately, there has Validation is necessary to ensure http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Alternatives to Laboratory Animals SAGE

How Much Flexibility is Possible When Validating New In Vivo and In Vitro Toxicity Test Methods?

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References (15)

Publisher
SAGE
Copyright
© 2003 Fund for the Replacement of Animals in Medical Experiments
ISSN
0261-1929
eISSN
2632-3559
DOI
10.1177/026119290303100301
Publisher site
See Article on Publisher Site

Abstract

ATLA 31, 225–232, 2003 225 Editorial How Much Flexibility is Possible When Validating New In Vivo and In Vitro Toxicity Test Methods? validated serendipitously via the hazard data that Introduction they have generated, and by establishment of their reliability as a result of their use in various labora- tories. Validation Validation involves assessing the reliability and rele- Objectives vance of a test method for a specific purpose. The need to validate a test method can arise from its pos- The purpose of this editorial is to discuss the ways sible use in-house, or its proposed adoption to gener- in which new in vitro and in vivo methods should be ate data to be submitted to regulatory authorities. Validation for regulatory use is a more complex developed, validated and accepted for regulatory use, especially in relation to the Organisation for process (usually involving formal interlaboratory Economic Cooperation and Development (OECD) studies) than that for in-house application. It is the former type of validation that is the subject of this test guidelines, in the light of the overall process of validation, the criteria for which have been agreed editorial. internationally in recent years. Lately, there has Validation is necessary to ensure

Journal

Alternatives to Laboratory AnimalsSAGE

Published: May 1, 2003

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