As part of its Investigational New Drug (IND) enabling services, ITR Laboratories Canada offers a complete core-battery of in-vivo safety pharmacology studies in accordance with the International Conference on Harmonisation (ICH) Tripartite Guidelines S7A and S7B.

Safety pharmacology studies conducted at ITR Laboratories Canada are designed to investigate the potentially undesirable effects of test items on vital organ systems such as the cardiovascular, respiratory and central nervous systems. All safety pharmacology studies are conducted using fully validated and Part 11 compliant systems.

  • ECG, blood pressure, body temperature and locomotor activity monitoring by telemetry in freely moving animals
  • The animals are implanted with transmitters equipped with solid-tip ECG leads virtually eliminating muscle noise and movement artifact from the ECG signal
  • All data evaluated by a board certified veterinary cardiologist
  • A colony of pre-implanted animals is available at all times for a quick start
  • Respiratory rate, tidal volume, minutes volume and blood gas analysis
  • Head-out plethysmography in rats
  • Face mask connected to a pneumotach for dogs and monkeys
  • Hardware: Data Sciences International
  • Software: Notocord-hem

Functional Observation Battery (FOB):

  • Rats and mice
  • Observations performed to cover 3 functional domains
    • Behavioural
    • Autonomic
    • Neuromuscular (sensorimotor)
  • About 30 parameters evaluated
    • Observation of the animal in its home cage
    • Observation of the animal while being handled
    • Open field measurements
    • Evaluation of the animal’s reaction to various stimuli

Neurological Examinations:

  • Dogs and monkeys
  • About 15 to 20 test performed
    • Mental status
    • Gait and posture
    • Muscle tone
    • Spinal and facial nerve reflexes
  • Renal function test in saline-loaded animals
  • Urinalysis, including urine electrolyte measurements
  • Gastrointestinal transit in rats and mice
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