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.
- 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
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