Cardiac Functional Assays
Safety pharmacology studies are needed for assessment of the impact of any new chemical entity or biotechnology-derived product on vital organ systems before first-in-human drug testing.
These evaluations are essential steps in assessing of any acute or potentially life-threatening risks for the novel pharmaceuticals. Understanding of drug’s impact on vital organ systems helps the planning for all of the following human trials. Cardiac safety is one of the main causes of trial delay and drug abandonment. Assessment of drug-induced proarrhythmic risk and cardiac dysfunction at multiple levels is critical to modern cardiac safety screening.
Aurora offers various functional assays to asses cardiac safety including the action potential of Purkinje fibers as an important site for the initiation of arrhythmias. They are particularly sensitive to hERG inhibition and therefore to drug-induced prolongation of action potential duration (APD) and early after depolarization (EAD). Compared to ventricular muscles, Purkinje fibers may be a better model for studying QT prolongation-related torsade de Pointes (TdP). Aurora offers physiologically relevant rabbit whole-ventricle Purkinje fibers preparation for assessment of drug effect on action potential duration.
In addition, Aurora use arrhythmia model assays to investigate cardiac functionality. Emerging evidence against using QT prolongation as a surrogate maker of proarrhythmia necessitates the need for adopting more predictable drug testing models. Aurora provides a clinically relevant rabbit Torsades de Pointes (TdP) model to assess compound effects on ECG intervals and their proarrhythmic and anti-arrhythmic potential. Aurora’s safety pharmacology services help the researchers for getting data that meets all regulatory standards and used for an smooth transition of preclinical to clinical pharmacology. Our experts conduct safety pharmacology studies for your new chemical entity or biotechnology-derived product according to ICH safety pharmacology guidance.