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NAFTA Developmental Neurotoxicity Guidance Document: Case Study – Chemical X
Citation:
Crofton, K. AND Mary E. Gilbert. NAFTA Developmental Neurotoxicity Guidance Document: Case Study – Chemical X. European Food safety Association (EFSA)-Virtual, RTP, Virtual, ITALY, April 26, 2021.
Impact/Purpose:
A series of lectures on developmental neurotoxicology guideline (DNT) studes were presented to the European Food Safety Association (EFSA) by the three authors on this presentation. This seminar expanded on these previous educational seminars by exploring a Case Study of a typical chemical submission for a DNT. The goal is to inform reviewers of such datasets submitted to regulatory agencies in North America and Europe leading to more reliable and consistent evlaluations.
Description:
A series of lectures on developmental neurotoxicology guideline (DNT) studes were presented to the European Food Safety Association (EFSA) by the three authors on this presentation. This seminar expanded on these previous educational seminars by exploring a Case Study of a typical chemical submission for a DNT. Review of data for functional observation battery, motor activity, acoustic startle, learning and memory, and brain morphometry for a nominal chemical submitted for evaluation. A deep dive into the report and data and examples of strengths and weaknesses in the conduct, report, and interpretation of this 'real life' example are presented.