Cardiac Safety
Cardiac Safety Assessment
PhysioStim is an independant Preclinical Contract Research Organization of highly experienced electrophysiology experts. We perform cardiac safety assesment of your compounds from the earliest stages during drug discovery phase to hERG study and regulatory telemetry under GLP conditions.
The cardiac safety assays listed below can meet several of the following needs such as: regulatory study, toxicology study and also integrated assessment during drug discovery phases. Upon request we are able to perform on-demand models. We also respect the 3R principle and have already taken steps to comply with the upcoming CIPA guidelines, All our study are performed in compliance with all ICH S7A and S7B guidelines and Good Laboratory Practices.
Cardiac Ion Channels
Test your compounds on one or all the CIPA cardiac ion channels panel using the automated or manual patch clamp technique. All the “CiPA seven” ion channels: hERG* | hNav1.5 peak* | hCav1.2 * | hKvLQT1/MinK | hKir2.1 | hKv4.3 | hNav1.5 late
* = can also be performed under GLP conditions with manual patch clamp technique
Human Cardiomyocytes
Human iPSC Cardyomyocytes assays is strongly recommended by CIPA initiative for cardiac preclinical safety assessment. At PhysioStim, Human Cardyomyocytes are used on the xCELLigence RTCA Cardio ECR platform (48 wells plate) which allow us to record simultaneously Electrophysiology (MEA) and Contraction (Impedance) signals.
Isolated Perfused Heart
Besides prediction of QT prolongation, the Isolated Perfused Heart is also an integrative and native expressed system that could easily identify potential cardiotoxic effects of compounds (pro-arrhythmogenic, cytotoxic and contractility worsening). Therefore, this models could screen selective channel blocker but also multi-channel blocker or indirect channel regulator.
Purkinje Fiber
Action potential from Purkinje fibers provide a reproducible and sensitive predictions of QT prolongation. Thus the ionic channels involved in the Purkinje action potenial shape are similar to those of the human ventricular repolarization. Therefore any lengthening of action potential duration (APD) are highly predictible of human QT prolongation and incidence of ventricular arrhythmias.
Cardiac Telemetry (GLP)
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.
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