There is a spectrum of approaches to neurotoxicological science from high-throughput in
vitro cell-based assays, through a variety of experimental animal models to human …

Test article (TA)-induced seizures represent a major safety concern in drug development.
Seizures (altered brain wave [electrophysiological] patterns) present clinically as abnormal …

Biotherapeutic modalities such as cell therapies, gene therapies, nucleic acids, and proteins
are increasingly investigated as disease-modifying treatments for severe and life …

Regulatory guidelines recommend specialised safety pharmacology assessments in
animals to characterise drug-induced effects on the central nervous system (CNS) prior to …

The developmental neuropathology examination in juvenile toxicity studies depends on the
nature of the product candidate, its intended use, and the exposure scenario (eg, dose …

Seizures are complex electrophysiological disturbances affecting one or more populations
of brain neurons. Seizures following test article (TA) exposure pose significant challenges in …

The workshop titled State of the Science on Assessing Developmental Neurotoxicity Using
New Approach Methods was co-organized by University of Maryland's Joint Institute for …

Nonclinical safety studies are typically conducted to establish a toxicity profile of a new
pharmaceutical in clinical development. Such a profile may encompass multiple differing …

Existing nervous system sampling and processing “best practices” for nonclinical general
toxicity studies (GTS) were designed to assess test articles with unknown, no known, or well …

With the often-quoted phrase that “children are not small adults” and awareness in the
scientific and regulatory environment that specific safety assessment for many new drugs in …