Standard Cardiovascular Telemetry Study in Beagle Dogs
The standard study design for safety pharmacology studies is the Latin-square cross-over design, which is widely accepted as conferring the best statistical power (sensitivity to detect changes in cardiovascular parameters of interest).
Animals and Treatments in a Simple 4×4 Latin Square Experimental Design
Dosing is performed by the required route following a Latin Square sequence, with an appropriate recovery period between treatments based on known PK/PD profiles. Data are recorded both immediately prior to and following each exposure for a time interval appropriate to capture potential pharmacodynamic effects of the parent compound and metabolites, as applicable.
Cardiovascular Evaluations
ECG records are reviewed by a certified veterinary cardiologist or otherwise qualified expert. The following parameters are recorded and evaluated:
- Arterial blood pressure (systolic, diastolic and mean)
- Heart rate
- ECG parameters (including QT and corrected QT values)
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Article written by Raquel Gómez
