In 2013 the Cardiac Safety Research Consortium (CSRC), the Health and Environmental Sciences Institute (HESI), and the US Food and Drug Administration (FDA) proposed a paradigm to improve the assessment of the proarrhythmic risk of therapeutic compounds. This paradigm, the Comprehensive in-vitro Proarrhythmia Assay (CiPA), was introduced to provide a more complete assessment of proarrhythmic risk by evaluating and implementing currently available high throughput methods.
Download this app note to discover how patch-clamp can be used as part of an integrated risk assessment in:
- First-in-human studies
- Later stages of clinical development