Comparative analysis of data sciences international PhysioTel™ D70 and PhysioTel™ digital telemetry platforms

Abstract

Telemetric evaluations are largely conducted as part of the Safety Pharmacology core battery to satisfy ICH S7A and ICH S7B requirements for assessment of changes in hemodynamic and electrocardiographic measurements, respectively. Such evaluations have allowed for the collection of conscious ambulatory data from unanesthetized animal models. However; historically, acquisition limitations have precluded social housing of animals during the telemetric evaluation period due to signal interference. Technological advances in implantable telemetry devices and supporting hardware now offer benefits of greater signal quality, greater durations of implantation (due to upgraded battery usage and device construction), with the added capacity to offer group housing during the collection period. The current study was conducted to assess the enhancements offered by the PhysioTel Digital (digital) platform. Telemetric data were compared between moxifloxacin-treated animals using each telemetry platform. Both system evaluations were completed using a latin square cross-over dose design. Single-housed animals were used for the evaluation of the PhysioTelD70 (legacy) transmitter, while socially housed animals were used during the evaluation of the digital system. While both systems demonstrated equivalent changes in the potential for delayed ventricular repolarization (QTcV = >270 msec; up to ~45 msec from control at 15-16 hrs post dose), the digital telemetry system offers advantages by way of study setup efficiencies, reduced potential for collection error, and extended implant battery life, all while satisfying expectations for group housing of social animals. Under the current study condition, no meaningful differences in cardiovascular parameters were noted between individually and social housed animals. While no contamination issues were observed as a result of the social housing paradigm, considerations should be made to limit potential for contamination between treatment groups, and contamination of control, when evaluating socially housed animals.