Safety Pharmacology

Making decisions about your safety pharmacology study can be challenging. We can help. Charles River has established ICH core battery tests and supplementary models to meet current regulatory requirements and provide meaningful data. We can customize your study to address both your program- and compound-specific needs, or include our core safety parameters in toxicology studies as an efficient means of meeting regulatory expectations.

Our safety pharmacology facilities feature dedicated telemetry suites, surgical pharmacology capabilities and custom-built cardiovascular laboratories that allow for remote observation of the animals without disrupting data collection.

We have validated the use of electrocardiogram (ECG) pattern recognition software to increase the sensitivity of our ECG analyses, and have integrated automated arrhythmia detection for full ECG data sets.

Visit the Source for more information on our safety pharmacology capabilities.

The core battery of safety pharmacology studies should be included in small molecule IND-enabling programs to assess the acute and potentially life-threatening risks of novel pharmaceuticals for human use.

  • Cardiovascular System
    Blood pressure, heart rate, electrocardiograms (ECGs), left ventricular pressure, echocardiography
  • Respiratory System
    Respiratory rate, hemoglobin oxygen saturation, tidal and minute volumes
  • Central Nervous System (CNS)
    Functional observation battery (FOB), modified Irwin screen, body temperature, large animal neurological evaluations
  • In Vitro Electrophysiology
    Cloned human potassium channels (hERG)

Second-tier studies can be used to develop a greater understanding of mechanistic effects on vital functions, and evaluate potential adverse effects on other organ systems such as renal and gastrointestinal systems.

  • Tier II Assessments
    Cardiovascular system, central nervous system (CNS) and respiratory system assessments
  • Renal/Urinary
    Renal function and general clinical chemistry
  • Gastrointestinal
    Motility and function
  • In Vitro Electrophysiology
    Anticipated CiPA battery

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