Safety Pharmacology

Safety pharmacology studies evaluate the potential for off-target drug effects on major organ systems, as well as the reversibility of any characterized effects prior to human use. When filing an IND application, safety pharmacology studies are a requirement prior to the start of Phase I human clinical trials.

IITRI offers the core battery of safety pharmacology tests for monitoring the potential effects of a drug candidate on the central nervous system, cardiovascular system and respiratory system. These can be performed as stand-alone studies or integrated into repeat-dose studies depending upon indication and requirements of the FDA. IITRI’s experienced team will work closely with you to design the appropriate study to meet regulatory requirements.

Core Services

  • Central nervous system
    • Functional Observation Battery (FOB) to detect effects on behavior, locomotion, and coordination
    • Expanded battery to assess neurotoxicity
  • Cardiovascular system
    • Telemetry: heart rate, blood pressure, ECG and body temperature
    • hERG assays to evaluate cardiac ion channels
  • Respiratory system
    • Plethysmography: respiratory rate, tidal volume, and minute volume

Available Animal Models

  • Rodent
  • Canine

The IITRI Advantage

  • Integrated study design that evaluates both safety and traditional toxicology endpoints, and meets the requirements of the FDA and other international regulatory agencies
  • Personalized study design to meet unique needs of the sponsor
  • Highly experienced and tenured scientific staff, providing you with a seasoned and stable project team
  • Technical advisory and support regarding interpretation of study results