Preclinical safety pharmacology and neurobehavioral science investigations at MPI Research are designed to assess the potential for adverse pharmacologic events subsequent to acute or chronic therapeutic drug treatment. We offer comprehensive and integrated safety pharmacology and neurobehavioral sciences services, with individual study expertise ranging in scope from ion channel function to whole-animal investigations. All safety pharmacology and neurobehavioral science experiments conducted by our highly qualified scientific staff, and using validated instrumentation, are based on current International Conference on Harmonisation (ICH) Tripartite Guidelines (S7A and S7B). Our service-oriented, flexible, and innovative scientists are here to fully support you in developing a thorough, yet directed and timely safety profile.

Services/Capabilities

Core Battery Studies

Central Nervous System

• Functional Observational Battery (FOB)
  • Rat
  • Mouse
  • Canine
  • Nonhuman primate
• Quantitative locomotor activity
  • Rodent

Cardiovascular System

• GLP hERG assessment using whole cell patch clamp electrophysiology techniques (non-GLP HTS hERG assessment using planar perforated patch technology is also available)
• Telemetry in freely moving animals (blood pressure, heart rate, electrocardiogram, body temperature, troponins)
  • Canine
  • Nonhuman primate
  • Swine
• Restrained/anesthetized animal models (blood pressure, heart rate, electrocardiogram, troponins)
  • Rodent (nondefinitive screening studies only)
  • Canine
  • Nonhuman primate
  • Swine
  • Guinea pig

Respiratory System

• Restrained animals (tidal and minute volumes, respiratory rate)
  • Canine
  • Nonhuman primate
• Freely moving animals (tidal and minute volumes, respiratory rate, peak inspiratory and expiratory flow, inspiratory and expiratory time, other derived parameters, as specified)
  • Rodent
  • Guinea pig

Targeted/Supplemental Studies

Central Nervous System

• Passive avoidance
• Acoustic startle response
• Ototoxicity (in collaboration with the Kresge Hearing Research Institute at the University of Michigan)
• Rota-rod assessment
• Analgesia/hyperalgesia assessment
  • Rodent: tail flick, hot plate, Hargreaves, writhing assays
  • Rhesus and cynomolgus nonhuman primates: tail withdrawal
• In vivo drug interaction studies
• Perfusion and specialized neurohistopathology
• Seizure threshold assessment/proconvulsive models
• Positive Emission Tomography (PET) imaging
• Electrophysiological characterization of ion channel targets in primary neurons and brain slice preparations (i.e., circuit excitability)

Cardiovascular System

• GLP Action Potential Duration (APD) assessment using Purkinje fibers
  • Canine
  • Rabbit
• Langendorff isolated perfused heart model to evaluate cardiac electrograms, pressure, and contractility parameters, and arrhythmogenic potential
  • Rabbit
• Cardiac output/peripheral artery flow
• Vascular/peripheral resistance
• Ventricular pressure, pulmonary arterial pressure
• Ultrasound/echocardiography
• In vivo drug interaction studies
• Electrophysiological characterization of cardiac myocyte ion channel targets and myocardial wedge preparations

Respiratory System

• Lung resistance and compliance measures in anesthetized rodents
• Standard blood gas analyses and co-oximetry measures rodents and large animals

Renal/Urinary System

• Screening tests including correlated sampling of selected blood and urine parameters and calculation of creatinine clearance
  • Rodent
  • Canine
  • Nonhuman primate
• Definitive tests employing correlated sampling of selected blood and urine parameters, as well as other functional measures of glomerular and tubular function
  • Canine
  • Nonhuman primate
  • Swine

Gastrointestinal System

• Gastric emptying and gastrointestinal propulsion
  • Rodent
• GI motility and smooth muscle contractility assessments in large animals

Behavioral Pharmacology Studies (fully GLP compliant)

• Drug dependence liability evaluations
  • Drug Discrimination: rodent and nonhuman primate
  • Self Administration: rodent and nonhuman primate
  • Drug Dependence assessments performed in any suitable species

For more detailed information regarding the full range of in vitro and in vivo Safety Pharmacology/Neurobehavioral Sciences service offerings please contact: SafetyPharm@mpiresearch.com or call 269.668.3336.


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