Cardiac Safety of Noncardiac Drugs

It is generally easy to define the efficacy of a new the- peutic agent. However what is even more difficult and more challenging yet more important is to define its safety when administered to millions of patients with multi-faceted d- eases co-morbidities sensitivities and concomitant medi- tions. The commonest cause of new drug discontinuations cause for disapproval from marketing and removal from the market after approval is a drugs effect on cardiac repolari- tion which is essentially identified by increasing the duration of the QTc interval duration on the standard 12-lead elect- cardiogram (ECG). Cardiac Safety of Noncardiac Drugs: Practical Guide- Joel Morganroth MD lines for Clinical Research and Drug Development is designed to present the current preclinical clinical and re- latory principles to assess the cardiac safety of new drugs based primarily on their effects on the ECG. Practical gu- ance to define cardiac safety at all stages of clinical research and drug development are featured and discussed by inter- tionally recognized experts with academic industrial and regulatory experience. Each chapter contains the best ava- able evidence the authors personal opinions areas of c- troversy and future trends. Although some of the areas are highly specialized this book has been designed for a broad audience ranging from medical and graduate students to cli- cal nurses clinical trial coordinators safety officers data managers statisticians regulatory authorities clinicians and Ihor Gussak MD PhD scientists.