Abstract
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.
Highlights
Safety assessment methods are necessary to determine if new chemicals and products are safe or if they may adversely affect the health of people, animals, and the environment
Integrated testing strategies that consider information and data from such assays and various test methods are being developed (Stokes, 2007). Prior to their use for regulatory decision-making, new methods and strategies must undergo appropriate validation studies to determine if they can provide equivalent or improved protection compared to existing methods and to determine if reproducible results can be obtained in different laboratories (ICCVAM, 1997, 2003; OECD, 2005)
The NTP Roadmap envisions moving from toxicology studies that depend on observing the actual adverse outcome from chemical exposures, such as cancer and birth defects in animal models, to one based on understanding and detecting cellular and molecular perturbations in simpler models such as cell cultures and lower organisms that are predictive of these eventual adverse outcomes
Summary
Safety assessment methods are necessary to determine if new chemicals and products are safe or if they may adversely affect the health of people, animals, and the environment. 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. Integrated testing strategies that consider information and data from such assays and various test methods are being developed (Stokes, 2007) Prior to their use for regulatory decision-making, new methods and strategies must undergo appropriate validation studies to determine if they can provide equivalent or improved protection compared to existing methods and to determine if reproducible results can be obtained in different laboratories (ICCVAM, 1997, 2003; OECD, 2005). Adequate validation will expedite the acceptance and use of new test methods and strategies that support improved safety assessments and contribute to reduced animal use for regulatory testing. This paper will discuss emerging innovative technologies, concepts, and approaches applicable to regulatory safety assessments, and opportunities and challenges for their scientific validation
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