Accelera offers a complete "core battery" of regulatory Safety Pharmacology studies. Employing state-of-the-art technology for data collection, analysis and storage, all studies are GLP (21 CFR part 11) compliant and designed in line with the latest regulatory guidelines.
IND-enabling Safety Pharmacology Package
Core Battery Studies (ICH S7A/S7B):
- In vitro IKr
- Cardiovascular System: Telemetry study in dogs or nonhuman primates
- Respiratory System: Plethysmography study in rodents
- CNS: Modified Irwin in rodents
Other Safety Pharmacology Services
- Cardiovascular function (non QT) in rats
- Cardiovascular function (including QT) in guinea pigs and rabbits
- Cardiovascular (telemetry) and respiratory (whole body plethysmography) test in rats
- Intestinal transit (charcoal meal) in rats or mice
- Kidney function in rats
General Toxicology/Safety Pharmacology Integrated studies
Our Safety Pharmacology and General Toxicology experts collaborate to design and execute integrated toxicology protocols including the assessment of critical safety pharmacology endpoints.