Purpose

    • Studies are performed to determine whether a drug causes on- or off-target acute effects on critical organ systems
    • Dose responses identified in these studies serve to establish a safety margin for the first in human (FIH) dose regimen

     

    Cardiovascular system

    • Blood pressure, heart rate, and electrocardiogram
    • In vivo, in vitro, and/or ex vivo methods are used to evaluate repolarization and conductance abnormalities
    • hERG and Purkinje studies (in vitro)

Central Nervous system

  • Motor Activity, behavioral changes, coordination, sensory/motor reflex responses and body temperature should be evaluated
  • Functional Observational Battery (FOB)
  • Irwin’s Test

Respiratory system

  • Respiratory rate and other measures of respiratory function (e.g., tidal volume or hemoglobin oxygen saturation)
  • Evaluation of total respiratory system and the mechanical properties of the lung
  • Whole-body plethysmography

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