Abstract
The invasive telemetry system and snapshot recording of ECG are commonly used to monitor cardiovascular (CV) endpoints in safety pharmacology and toxicity studies. Due to the recent development of non-invasive jacket telemetry systems, CV endpoints can be monitored for longer periods on toxicity studies in unrestrained dogs and monkeys. It is essential to habituate animals to the jacket prior to the data collection period to obtain good quality data. The purpose of this study was to determine the optimal habituation period based on heart rate response. Heart rate (HR) was collected from 4 jacketed non-human primates (NHPs) following 3 consecutive occasions of jacket habituation. Heart rate was also collected from two sets of canine jacketed dogs (Set A: 18 dogs, Set B: 4 dogs) following 3 and 7 consecutive occasions of jacket habituation. Heart rate data collected following 3 and 7 day jacket habituation was compared with the Testing Facility’s historical control data collected from non-jacketed, invasive telemetry models in both species. The Testing Facility’s historical control data consisted of an average HR collected from 107 primates and 145 canines. Heart rate collected from jacketed monkeys (following 3 day habituation) and dogs (following 3 and 7 day habituation) are comparable to data from non-jacketed animals. Therefore, we concluded that a three day habituation is optimal to prevent undesirable effects in the CV data that may result from insufficient jacket habituation.
