Neurobehavioral Sciences

///Neurobehavioral Sciences
Neurobehavioral Sciences 2017-07-04T10:25:30+00:00

Regardless of the therapeutic target, any new chemical entity that penetrates the central nervous system (CNS) requires preclinical analysis of its abuse and dependence liability potential. Increasing regulatory concern to assess this and other CNS-mediated effects demand specialized neurobehavioral testing strategies that comply with both international health and drug control guidelines. Selecting the key drug and behavioral contingencies to use in the assessment is critical, as poorly designed studies can lead to false positives or underestimated liability that may manifest later in clinical trials or during the first few years of clinical use.

At MPI Research, we understand that the choice of a qualified partner for this function is critical. With our history of responding quickly to industry needs, MPI Research has been the first CRO to offer fully GLP-compliant abuse liability assays in both rodents and nonhuman primates in accordance with regulatory guidelines worldwide. We also conduct preclinical screening in other standard models, addressing pain and specialized sensory functions, as well as various psychological and neurological disorders.

MPI Research responds to your abuse and dependence liability testing challenge with

  • Fully GLP-compliant abuse and dependence liability assays in rodents and nonhuman primates (equipment and study conduct)
  • Conformance with international health agency and drug control regulatory recommendations and guidelines
  • The experience, insight, and flexibility required for the development of customized models to appropriately characterize a wide range of therapeutic targets
  • Industry leadership in abuse liability assessment
  • State-of-the-art ototoxicity testing laboratory leading the industry in GLP-compliant in-life and post-life measures of auditory function and recovery
    • Guinea pig, rat, feline, mice, and nonhuman primate (NHP)
    • Studies are designed according to test article treatment areas (safety, prevention, restoration, or efficacy).
    • Capacity to conduct auditory brainstem response evaluations, cytocochleograms, and specialized otic histopathology
  • Knowledgeable Study Directors, experienced in both drug control and health safety regulatory agency requirements
    • Expert knowledge of U.S. and international drug control standards
    • Proficiency in the “8-factor” analysis conducted independently by the FDA and DEA before NDA approval (The director of our program has a five-year employment history at the Drug Enforcement Administration)
  • Clear understanding of the need to conduct neurobehavioral studies before Phase II testing with all drugs that cross the blood-brain barrier, regardless of target or therapeutic indication, particularly those entities possessing a novel mechanism of action
    • Expertise with compounds, including biologics, that target known major neurotransmitter  systems involved in reward/reinforcement (e.g., dopamine, opiate, serotonin, Gamma-AminoButyric Acid [GABA]), and which may require appropriate behavioral testing
  • GLP-validated assays for –
    • Self-administration (rat, NHP)
    • Drug discrimination (rat, NHP)
    • Locomotor activity assessment (rodent)
    • Dependence potential (rodent, NHP)
    • Conditioned place preference/aversion (rodent)
  • Pain/analgesia assessment
    • Tail flick, hot plate, Hargreaves, Von Frey, and writhing assays (rodent)
    • Tail withdrawal (rodent and NHP)

Since pain assessment models should incorporate measures of general motor activity to ensure the selectivity of the new chemical entity and peripheral or CNS pain pathways, we offer

  • Accelerating rotarod performance (rodent)
  • Infra-red motor activity monitoring chambers (Kinder Scientific, rodent)
  • Morris Water Maze (mice, rats)
  • Seizure induction/blockade assessment
  • Functional and structural ototoxicity evaluation
    • Auditory Brainstem Response (ABR) electrophysiology (guinea pig, rat, feline, mouse, NHP)
    • Distortion product otoacoustic emissions (DPOAE) testing (rodent)
    • Definitive cytocochleogram preparation and analysis
    • Gross and microscopic otic histopathology examination
  • Integrative neurological evaluations of objectively verifiable behavioral changes associated with movement disorders, such as
    • Parkinson’s disease
    • Huntington’s disease
    • Dystonia, ataxias, and other paradoxical movement disorders