General Nonclinical Testing B guidelines Strategy proposed in ICH S7B guidelines

Objectives :

PhysioStim evaluates the cardiovascular safety of assay compounds compared to reference compounds in accordance with the CPMP Points to Consider document (CPMP 986/96; 1997) and ICH S7B guidelines (Step 4, May 2005).
These documents recommend a greater focus on both the in vitro measurement of the cardiac action potentials (using the intracellular microelectrode technique) and ionic currents (using the patch-clamp technique) and the in vivo assessment of effects due to the prolongation of the QT interval.

electrophysiology,cardiac,purkinje fibre,muscle papillary,heart,electrocardiogram,cardiac cell,action potential,microelectrode

General Nonclinical Testing Strategy

To propose our clients in vitro models which allow to detect possible arrhythmogenic adverse effects induced by pharmacological substances:

• human ionic channels (hERG, Na_v1.5, K_vLQT₁)
• cardiac preparations for recording of action potentials and/or contraction
In accordance with ICHS7A/S7B guidelines

arrythmia,pharmacological study, toxicity,cardiovascular,ionic ducts,QT interval,BPL,quality assurance, TRIADS, Triangulation Reverse use dependence, Instability, Dispersion, Excitation-contraction coupling, Atria conduction, Sodium channels, potassium channels, patch clamp
herg assay, nav1.5 assay, kvldt1 assay, actions potential in normal and physiopathological conditions