The environment of Safety Pharmacology is moving on these last few years with the emergence of the new paradigm called CiPA Initiative (Comprehensive in-vitro Proarrhythmia Assay) in order to replace the current ICH S7B and ICH E14 guidelines. This new strategy is proposed by expert working groups from FDA (Food and Drug Administration), HESI (Health and Environmental Sciences Institute) and CSRC (Cardiac Safety Research Institute).
The CiPA pathway is composed of in-vitro and in-silico technologies to improve risk assessment.
The 3 main elements of the CiPA initiative:
- Assessment of drug effects on the main critical human ventricular ion channel currents responsible of both the depolarization and repolarization process of the cardiac action potential.
- The datasets obtained are used for in-silico integration of the ion channel effects to determine the net effects on the cardiac action potential.
- The last part is to check the outcome of in-silico modeling results in a fully integrated biological system like Human Induced Pluripotent Stem Cell Derived Ventricular Cardiomyocytes.
For more details, visit the CiPA website here