Safety Pharmacology
As part of its Investigational New Drug (IND) enabling services, ITR Laboratories 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 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.
Safety Pharmacology in vital organ systems
ECG, blood pressure, body temperature, and locomotor activity monitoring by telemetry in freely moving animals (Dogs, Monkeys, and Minipigs/Nanopigs)
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, minute volume, and blood gas analysis
Head-out plethysmography in rats
Face mask connected to a pneumotach for dogs, monkeys and minipigs/nanopigs
Hardware: Data Sciences International
Software: Ponemah
Functional Observation Battery (FOB):
Rats and mice
Observations performed to cover 3 functional domains:
Behavioral
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 tests 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