Neurobehavioral testing is used to detect toxic effects of drugs or chemicals on the brain and nervous system. It is a core part of safety pharmacology and preclinical testing for FDA approval of new drugs and biologics. It also is used to identify neurotoxic effects of chemicals to evaluate occupational or environmental risk, to understand the effects of chemical weapons and help evaluate potential therapeutics after exposure.
Neurobehavioral testing measures effects on central nervous system (CNS) and peripheral nervous system (PNS) function, including sensorimotor and locomotor activity, neuromuscular integrity, reflex responses, perception and cognition, including learning and memory.
Testing methods can be grouped into three tiers of increasing sophistication and specificity:
- Tier I uses observational methods to assess broad measures of neurological function.
- Tier II builds on Tier I observations with more sophisticated, quantitative tests used to uncover a more nuanced understanding of neurological effects on specific systems.
- Tier III testing examines the mechanisms underlying neurotoxic effects seen in Tier I and II tests including use of special histopathological analysis and stains.
1. Extensive subject matter expertise
The organization you are considering should be recognized across the industry for their years of preclinical experience and knowledge of neurobehavioral testing methods. Do they have staff with extensive experience in study design and method development and validation?
2. Proven performance
The organization is able to provide historical control data to validate the effectiveness of their methods. They have a long track record of safety and compliance.
3. Ability to meet regulatory requirements
The testing organization is able to perform all phases or required preclinical or regulatory testing. They are certified in Good Laboratory Practice (GLP) and able to perform GLP studies. They have experience in conducting studies to meet regulatory requirements for the relevant agency (e.g. FDA, EPA).
4. Ability to produce highly defensible and reproducible data
They have certified or validated test equipment already operational to eliminate set-up costs and risks associated with bringing test equipment online. They have existing procedures with built-in quality control controls for producing reliable and reproducible data. They have methods in place to quantify measurements for neurobehavioral effects and the ability to automate data collection where appropriate.
5. Overall capacity and ability to meet timelines and budgets
The organization has demonstrable experience in designing and managing large/high-volume studies and has laboratory equipment and methods in place for high-throughput studies. The organization has the depth of personnel and test equipment to ensure quick turnaround and guarantee that schedules can be met, as well as provide developers with economies of scale that minimize test costs. The organization has the capability to perform simultaneous testing (e.g. cardiovascular) where appropriate to reduce project costs and timelines.
6. Multi-species capabilities
The organization is equipped and certified to handle both rodent and large animal models. They have validated methods in place for neurobehavioral testing with non-rodent species and a proven ability to develop and validate new models and methods. They follow all legal and ethical guidelines for care and testing of animal subjects.
7. A provider of essential advanced development and technical reachback capabilities for developers
The organization should be a research partner, providing developers with analysis of neurobehavioral data to help them make effective decisions for product development, regulatory compliance or policy. They are committed to ensuring that the developer’s research and development investment is provided the highest probability of success through effective neurobehavioral testing. The organization must have complimentary science and engineering staff beyond neurobehavioral testing services and the ability to provide comprehensive toxicology services, including general, cardiovascular, pulmonary and inhalation.
8. The highest ethical standards
The testing organization must have proven procedures in place to manage organizational conflicts of interest, perceived or otherwise. The testing organization must maintain an unbiased approach to testing and evaluation throughout the process.
Detecting Neurobehavioral Effects: Considerations in the Design & Execution of Neurobehavioral Studies.