Points to consider emerging from a mini-workshop on cardiac safety: assessing torsades de pointes liability.
A mini-workshop on cardiac safety focusing on assessing drug-induced Torsades de Pointes (TdP) liability was convened as part of the 6th Annual Meeting of the Safety Pharmacology Society. The purpose of this brief publication is to disseminate the salient points emanating from this workshop as a means of engaging the scientific community in the appropriate discussions needed to advance this important field of human safety. The recommendations in this publication extend those of the workshop on "Moving Towards Better Predictors of Drug-Induced Torsades de Pointes" held in November 2005 under the auspice of the International Life Sciences Institute, Health and Environmental Sciences Institute; they fall into four key areas: molecular and cellular biology underlying TdP, dynamics of periodicity, models of TdP proarrhythmia and key considerations for demonstrating utility of non-clinical models. The reader is encouraged to consider the recommendations emanating from the two workshops and align these with ongoing studies in their laboratories. The authors intend to convene a workshop in 2009/2010 to judge advancements in the field of study of drug-induced TdP and make recommendations for a focused validation of those methods holding the greatest promise of improving the predictivity of this unwanted human cardiac risk.
Bass
Alan
A
Investigational and Regulatory Safety Pharmacology, Schering-Plough Research Institute, 2015 Galloping Hill Road, Kenilworth, NJ 07033-0539, USA. alan.bass@spcorp.com
Valentin
Jean-Pierre
JP
Fossa
Anthony A
AA
Volders
Paul G A
PG
D000818:Animals; D035843:Biomedical Research / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D008133:Long QT Syndrome / Q000517:prevention & control; D016171:Torsades de Pointes / Q000139:chemically induced* / Q000175:diagnosis / Q000517:prevention & control