In the design and execution of safety pharmacology and toxicology studies, vast experience in stand-alone and integrated repeat-dose designs is necessary. Our safety pharmacologists are fluent in the latest technology and assessments, including the use of implanted and jacketed animals for telemetry (JET) for the collection of continuous electrocardiographic and hemodynamic data in large animals.
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
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.