Chapter 10

Neurotoxicity

A. Lawrence Gould

A. Lawrence Gould

Merck Research Laboratories, 770 Sumneytown Pike, West Point, PA, 19486, USA

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First published: 12 December 2014

Summary

The potential neurotoxicity of a compound can be evaluated in various ways. Neurotoxicity screening can be based on a battery of measurements and observations such as the functional observational battery that has been in use for a number of years. This chapter outlines briefly some statistical approaches that may be useful for the evaluation of neurological toxicity, especially as manifested in changes in electroencephalograms (EEG) recordings, in the context of clinical trials. It focuses on methods that can be implemented in a practical way for “routine” evaluation of neurotoxicity assessments obtained in the course of clinical trials. Key issues for EEG analyses include data reduction, accounting for potential correlations across time and among channels, and non-stationarity. EEGs generate a large amount of information and their analysis is complicated. Exploiting this technology for routine evaluation of potential toxicity of new products is currently a major challenge, but progress is being made.

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