Main issues addressed in the 2014-2015 revisions to the OECD Genetic Toxicology Test Guidelines
| Autor: | Francesco Marchetti, Elisabeth Lorge, Dan D. Levy, Véronique Thybaud, Jan van Benthem, George R. Douglas, Rita Schoeny, Martha M. Moore |
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| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Epidemiology Computer science Process (engineering) business.industry Health Toxicology and Mutagenesis media_common.quotation_subject Data interpretation 010501 environmental sciences 01 natural sciences Statistical power Test (assessment) Biotechnology Economic cooperation 03 medical and health sciences 030104 developmental biology Risk analysis (engineering) Quality (business) business Genetics (clinical) Reliability (statistics) 0105 earth and related environmental sciences media_common Genetic Toxicology |
| Zdroj: | Environmental and Molecular Mutagenesis. 58:284-295 |
| ISSN: | 0893-6692 |
| Popis: | The Organization for Economic Cooperation and Development (OECD) recently revised the test guidelines (TGs) for genetic toxicology. This article describes the main issues addressed during the revision process, and the new and consistent recommendations made in the revised TGs for: (1) demonstration of laboratory proficiency; (2) generation and use of robust historical control data; (3) improvement of the statistical power of the tests; (4) selection of top concentration for in vitro assays; (5) consistent data interpretation and determination of whether the result is clearly positive, clearly negative or needs closer consideration; and, (6) consideration of 3R's for in vivo assay design. The revision process resulted in improved consistency among OECD TGs (including the newly developed ones) and more comprehensive recommendations for the conduct and the interpretation of the assays. Altogether, the recommendations made during the revision process should improve the efficiency, by which the data are generated, and the quality and reliability of test results. Environ. Mol. Mutagen. 58:284-295, 2017. © 2017 Wiley Periodicals, Inc. |
| Databáze: | OpenAIRE |
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