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From SOPs to Reports to Evaluations: Learning and Memory as a Case Study of how Missing Data and Methods Impact Interpretation
Citation:
Moser, V. C. AND A. Hofstra. From SOPs to Reports to Evaluations: Learning and Memory as a Case Study of how Missing Data and Methods Impact Interpretation. Presented at Society of Toxicology Annual Meeting, San Diego, CA, March 22 - 26, 2015.
Impact/Purpose:
This abstract will be presented at the Society of Toxicology Annual Meeting March 22-26, 2015, in San Diego, CA,
Description:
In an era of global trade and regulatory cooperation, consistent and scientifically based interpretation of developmental neurotoxicity (DNT) studies is essential. Because there is flexibility in the selection of test method(s), consistency can be especially challenging for learning and memory tests required by EPA and OECD DNT guidelines (chemicals and pesticides) and recommended for ICH prenatal/postnatal guidelines (pharmaceuticals). A well reasoned uniform approach is particularly important for variable endpoints and if non-standard tests are used. An understanding of the purpose behind the tests and expected outcomes is critical, and attention to elements of experimental design, conduct, and reporting can improve study design by the investigator as well as accuracy and consistency of interpretation by evaluators. This understanding also directs which information must be clearly described in study reports. While missing information may be available in standardized operating procedures (SOPs), if not clearly reflected in report submissions there may be questions and misunderstandings by evaluators which could impact risk assessments. A practical example will be presented to provide insights into important variables and reporting approaches. Cognitive functions most often tested in guidelines studies include associative, positional, sequential, and spatial learning and memory in weanling and adult animals. These complex behaviors tap different brain areas and develop at different rates. Evaluation should include integration of treatment data including performance assessments (motor, sensory), control data (concurrent, historical, positive), and additional measures ofneuro- or other toxicity. Doing so can empower consistent and defensible risk evaluations. These considerations provide a stronger scientific basis for development of standard evaluation approaches for review and interpretation of DNT studies. This is an abstract of a proposed presentation and does not reflect US EPA policy.