Any behavioral change may have physiological significance: Benign neglect in tier I neurotoxicity testing

There have been remarkable advances in the early identification of behavioral changes predictive of neurotoxicity induced by xenobiotic administrations in laboratory animals during Tier I safety testing. By definition, this risk assessment is conducted before formal approval for use in humans. The intent of this regulatory-based drug approval process is to ensure public health, domestic tranquility and provide for the common defense against unwitting exposure to harmful therapeutics and promote the general welfare of human patients seeking the diagnosis, cure, mitigation, treatment, or prevention of disease. There is a contemporary movement by many researchers to diminish the threat to humans for many known toxicants to nullify, diminish and obviate the great advances in drug safety that have been established as the foundation of ‘good science’ in the drug approval process. The biggest threat to contemporary neurotoxicity screening may be emanating from inside the laboratory.