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 Safety Services

Cardiac Ion Channels

Preclinical cardiac safety

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

hERG GLP

hERG cardiac ion channel

hERG GLP assays is a mandatory study according to ICH S7B. Any new drug application (IND) requires testing a compound for hERG in GLP conditions. hERG assays under GLP conditions are essential to study the cardiovascular safety of a compound.

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.

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