The ICHS7B and ICH E14 guidelines will be soon replaced by new regulations that will apply to both preclinical and clinical studies. The comprehensive In Vitro proarrhythmya Assay (CiPA) initiative has the goal of increasing cardiac safety, recommending testing on seven ionic channels instead of one and the complementary use of in silico tools to simulate the impact of a drug candidate on the ventricular Action Potential of human cardiomyocyte cells.
Identify drug candidate safety window
In silico testing will also help to identify the drug candidate safety window through virtual screening of multiple concentrations, guiding in vitro and in vivo testing and resulting in a drastic reduction of risks and investments.
A unique tool to calculate safety markers and estimate in minutes clinical risks following CredibleMeds classification for multiple concentrations of a compound against the four most relevant ion currents.
A tool to conduct in silico safety trials on a population of human-induced pluripotential stem cells, for up to seven ion currents and at different concentrations.
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