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PreClinical Services |
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Safety Pharmacology
Safety Pharmacology studies are designed to assess the potential adverse pharmacodynamic effects of drug
compounds on major physiological systems (ICH S7A) and the probability for causing delayed ventricular
repolarization (QT prolongation) of human pharmaceuticals (ICH S7B).
In line with the current International Conference on Harmonisation (ICH) guidelines for safety pharmacology
testing, SNBL USA provides a comprehensive Safety Pharmacology Program which includes (but is not limited to)
assessment for QT prolongation.
SNBL USA has dedicated suites for nonhuman primate (NHP) telemetry studies, allowing for a variety of study
designs and group configurations. Our telemetry data acquisition program is flexible and can be configured
for either continuous (up to 30 hours) or intermittent (using scheduled recording) data collection. In addition,
our data acquisition system includes video and physiological data capture (synchronized) with remote
monitoring capabilities.
Core Battery Testing parameters that can be measured include:
Cardiovascular System
- Arterial blood pressure parameters (mean, systolic and diastolic)
- Left ventricular pressure (LVP) measurements (systolic, LVEDP, dP/dTmax, dP/dTmin, ET)
- Heart rate (derived from blood pressure)
- Electrocardiogram (ECG) parameters (includes durations and amplitudes):
- Rhythm and morphology evaluation by experienced cardiovascular electrophysiologists and/or board-certified cardiologists
- Appropriate QT correction
- Troponins (cardiac-specific necrotic biomarkers; optional)
Respiratory System
- Respiratory rate (derived from blood pressure)
- Arterial blood gases (pH, pO2, pCO2, sO2, and HCO3-act )
CNS Measurements
- Functional observational battery (FOB) - included in rat model
- Motor activity
- Body temperature (abdominal)
- Behavioral assessment using video technology
Additional services include:
- Anesthetized Measurements
- Follow up and Supplemental Safety Pharmacology Studies
- General Toxicology Studies (Telemetry Arm)
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