Current Edition


Evolution of the Proarrhythmic Cardiac Safety Regulatory Landscape: The Likely Revision of ICH Guideline E14 and its Consequences

Since its release 10 years ago, ICH Guideline E14 has governed the clinical proarrhythmic cardiac safety regulatory landscape: it has been adopted by the United States Food and Drug Administration (FDA), Health Canada, the European Medicines Agency (EMA), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). During recent years there has been growing interest in an alternative approach to exonerating a drug from an unacceptable proarrhythmic liability, one that focuses on exposure-response (ER) modelling. In this paper, J. Rick Turner, Jared Schettler et al. at Quintiles provide a brief historical overview of the regulatory landscape in place at the time of its preparation, and look ahead to the consequences of the likely revision.….pdf