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European Pharmaceutical Contractor
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| Boaz Mendzelevski, a Cardiac Safety Consultant, examines drug-induced repolarisation abnormalities and proarrhythmia with regard to improving cardiovascular safety in drug development
Cardiac safety is a relatively new field in drug development clinical research. It first emerged as a regulatory focus after the high-profile withdrawals of drugs such as terfenadine and cisapride in the 1990s, and became synonymous with drug-induced QT prolongation and its associated cardiac arrhythmia – torsades de pointes (TdP). Recent regulatory guidance, most notably ICH-E14, brought cardiac safety into the forefront of regulatory medicine. Since 2000, cardiac safety became the primary reason for drug withdrawals and non-approval of new drugs. Early detection of potential QT prolongation and TdP liability is now an essential component of the drug development paradigm.
Most recently, the scope of cardiac safety drug development has expanded and now covers three major areas of potential drug-induced cardiac toxicity: cardiac repolarisation, or drug-induced QT prolongation leading to cardiac arrhythmia; vascular thrombosis leading to myocardial ischemia and infarction; and direct myocardial toxicity leading to loss of cardiac tissue and heart failure. This article will provide an up-to-date overview of the evolving field of drug cardiac safety and the science behind drug-induced cardiotoxicity, current regulatory requirements and drug development strategies to improve management of drug cardiac safety and bring safer medicines to market. |
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10th-Anniversary Event RFID Journal LIVE! 2012
3-5 April 2012, Walt Disney World Swan and Dolphin Resort, Orlando, Florida
RFID Journal LIVE! 2012, our tenth annual conference and exhibition, is the only event where you can learn how to use RFID technologies to improve your pharmaceutical and medical packaging business, from real-world case studies across all applications, including asset tracking, logistics and transportation, supply chain management, warehouse and inventory management, security and more. Learn from a customized program featuring more than 50 end-user case studies and 8 industry-specific and how-to conference tracks.
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