Safety Pharmacology

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.