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Safety Pharmacology

 

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.

Other Services

General Toxicology
Reproductive Toxicology
Isotope Chemistry & Drug Disposition
Bioanalytical Services
Regulatory Services
General Toxicology
Reproductive Toxicology
Isotope Chemistry & Drug Disposition
Bioanalytical Services
Regulatory Services

 Need information?

Please contact us if you would like to arrange a visit to your company by one of our representatives, to request a proposal, or for any more information on our services.

info@accelera.org

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