Cardiac telemetry assays
Cardiac telemetry assays for preclinical drug studies
A radio transmitter equiped animal (telemetry study) offers the ability to measure in a non-invasive manner cardiovascular and other activities (ECG, blood pressure and body temperature) in conscious animals within controlled environment. After the In vitro hERG evaluation, the ICH S7B guideline requires the use of the telemetry study in conscious animal under GLP conditions and to assess the potential of a test substance to delay ventricular repolarization (QT interval prolongation).
Cardiac telemetry assays & Preclinical Safety Studies
Telemetry assay aim to identify potential QT prolongation, late in cardiovascular safety package. ICH Guidelines state that telemetry studies under GLP conditions are mandatory, due to numerous clinically approved drugs reported to increase the pro arrhythmogenic risk (including sudden death) through QT prolongation. As a result, a large number of drugs have been withdrawn during late stage of clinical trials or from the market.
In order to preserve animal welfare, all aspects of the telemetry study are performed in compliance with EU Directive 2010/63. Moreover, PhystioStim will not accept to offer In vivo studies without non-pertinent ethical justification.
What is the added value of such a study?
- Is a mandatory study according to the ICH Guildelines
- Threshold dose of QT prolongation
- Leading to the determination of the safety range versus efficacious dose
- You obtain your safety margin
Technique
- Rat, dog, mini-pig, pig, monkey (under ethical justification)
- Implantation of a telemetric radio transmitter for measurements of arterial blood pressure, temperature and ECG
- Analgesia and antibiotics
- At least 10 days of recovery
- Continuous recording of blood pressure, heart rate and ECG for long-term period
Measured parameters
- Arterial blood pressure (mmHg)
- Heart rate (beats/min)
- PR, QRS, RR, QT and QTc intervals (ms)
- Electrophysiological and haemodynamic parameters
Main advantages
- Technically robust
- Highly informative
- Strongly replicable
- Plasma sampling
- Analytical quantification under GLP conditions (also mandatory) could be performed by the Sponsor or with PhysioStim
Additional Cardiac Safety Assays
