Safety Pharmacology
Services
We are ready to answer your questions and provide guidance.
Safety Pharmacology
Services
We are ready to answer your questions and provide guidance.
Safety Pharmacology
The safety pharmacology core battery studies are conducted as an essential step in an IND program to 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 physiological 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 (piggy-backed) 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 such as ICH S7A/S7B.
In Vivo and In Vitro Safety Pharmacology Core Services
| Central Nervous System (CNS) |
• Functional Observation Battery (FOB) to detect effects on behavior, locomotion, and coordination (including peripheral neuropathy studies in NHPs) • Neurotoxicity assessment |
| Cardiovascular System |
• Telemeterized dogs: Systolic, diastolic and mean arterial blood pressures, heart rate, electrocardiogram (RR, PR, QRS, QT and QTc intervals) and body temperature monitored continuously • hERG inhibition in vitro assays to evaluate potential for QT interval prolongation |
| Respiratory System | Plethysmography: respiratory rate, tidal volume, and minute volume |
Available Animal Models
- Rodent
- Canine (telemeterized; implanted or jacketed as needed)