Safety Pharmacology

Safety pharmacology studies assess potential adverse pharmacological effects on major organ systems.  A range of studies are available at Smithers Avanza using validated data collection systems including Ponemah™ and Provantis® to capture and process data.  The study designs are flexible and have been used as screening assays for candidate selection, to evaluate drug interactions and mechanism, as part of general toxicology studies, and for functional safety assessment of a wide variety of small molecules, peptides, and recombinant proteins.  Core battery tests of the cardiovascular, respiratory and CNS are conducted in compliance with International Conference on Harmonisation (ICH) Tripartite Guidelines S7A and S7B.

Smithers Avanza offers a collaborative and consultative approach to study design and execution to meet the diverse needs of our clients.  The technical staff has extensive experience both in surgical model preparation and execution.  The scientific team has extensive background in both pharmacology and physiology of major organ systems.  We recognize that rapid communication of study findings and regular updates are essential to meeting internal deadlines and regulatory submissions.  Our protocols and study reports are recognized for being of high quality and final reports are provided to meet our client’s timelines.

Smithers Avanza Toxicology Services performs the following:

Central Nervous System (Rodents)

  • Functional Observational Battery (FOB) and Modified Irwin Screen
  • Quantitative motor performance evaluation
  • Pro-convulsant assessment
  • Catalepsy assessment
  • Barbiturate-induced sleeping time
  • Tail flick test
  • CSF collection

 Cardiovascular System

  • Remote telemetry monitoring in freely moving rats, dogs, pigs, and non-human primates using DSI implants.
  • Physiology and pharmacology studies in anesthetized rabbits, dogs, and pigs
  • Continuous data collection
  • Board-certified veterinary cardiologist

Respiratory System

  • Whole body, head-out plethysmography in rats
  • Measurement of end-tidal CO2 and SpO2 in large animals
  • Continuous data collection

 Renal System

  • Urinalysis
  • Glomerular filtration rate
  • Osmolarity

 Gastrointestinal System

  • Gastric motility and transit