Current Edition

Evolving Methodologies in Cardiac Safety: Introduction to a Mini-Seriess

Rick Turner, PhD, Senior Director of Quintiles Cardiac Safety
Center of Excellence, submits the first instalment of a miniseries
on cardiac safety. The ICH E14 and ICH S7B Guidelines
have defined the proarrhythmic cardiac safety regulatory
landscape in the period circa 2005-2015. This paper provides
an overview of that landscape to set the scene for subsequent
discussions in this mini-series. Recently, other approaches have
gained additional attention. One of these is concentrationeffect
modelling, discussed in the following paper by Kleiman.…..pdf