Validation of innovative technologies and strategies for regulatory safety assessment methods: challenges and opportunities.
Advances in science and innovative technologies are providing new opportunities to develop test methods and strategies that may improve safety assessments and reduce animal use for safety testing. These include high throughput screening and other approaches that can rapidly measure or predict various molecular, genetic, and cellular perturbations caused by test substances. Integrated testing and decision strategies that consider multiple types of information and data are also being developed. Prior to their use for regulatory decision-making, new methods and strategies must undergo appropriate validation studies to determine the extent that their use can provide equivalent or improved protection compared to existing methods and to determine the extent that reproducible results can be obtained in different laboratories. Comprehensive and optimal validation study designs are expected to expedite the validation and regulatory acceptance of new test methods and strategies that will support improved safety assessments and reduced animal use for regulatory testing.
National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods, National Institute of Environmental Health Sciences, National Institutes of Health, Department of Health and Human Services, Research triangle Park, North Carolina 27709, USA. stokes@niehs.nih.gov
William S
WS
Stokes
Marilyn
M
Wind
D000826:Animal Testing Alternatives / Q000379:methods*; D000818:Animals; D003198:Computer Simulation; D003257:Consumer Product Safety / Q000592:standards*; D003657:Decision Making; D015386:Hazardous Substances; D008954:Models, Biological; D015203:Reproducibility of Results; D018675:Toxicity Tests / Q000379:methods* / Q000592:standards* / Q000639:trends
D015386:Hazardous Substances