Cardiac Safety of Noncardiac Drugs: Practical Guidelines for Clinical Research and Drug Development is designed to present the current preclinical, clinical, and regulatory principles to assess the cardiac safety of new drugs based primarily on their effects on the ECG. Practical guidance to define cardiac safety at all stages of clinical research and drug development are featured and discussed by internationally recognized experts with academic, industrial, and regulatory experience.

The serious nature of cardiovascular adverse drug reactions occurring in patients makes assessment of a drug's cardiac safety profile a high priority during both development and post-approval monitoring. Integrated Cardiac Safety provides necessary guidance and methodology for professionals assessing cardiac safety of drugs throughout all stages of the drug's life, from discovery and development through postmarketing research. This self-contained, reader-friendly text is valuable to professionals in the pharmaceutical, biotechnology, and CRO industries, pharmacologists, toxicologists, government officials, and students.

The ESC Handbook on Cardiovascular Pharmacotherapy, based on the most recent guidelines in cardiovascular pharmacology, and containing a comprehensive A-Z formulary of common and less commonly used cardiac drugs and drug groups, provides practical and accessible guidance on all areas of drugprescribing.Previously published as Drugs in Cardiology, this new edition has been developed by the ESC Working Group on Cardiovascular Pharmacology. Pharmacology is an integral aspect in almost all disciplines within cardiology and all cardiologists use cardiovascular drugs.Completely updated and aligned with the ESC Clinical Practice Guidelines for prescribing, this handbook is essential reading for consultants, registrars in training, general practitioners, specialist cardiac nurses and cardiovascular pharmacologists.

At a time when the field of cardiac safety is going through important changes, this unique book provides the rationale for, and cutting-edge explanations of, new regulatory landscapes that will likely govern cardiac safety assessments globally for the foreseeable future. Exposure-response modeling is already being accepted by regulatory agencies in lieu of the traditional Thorough QT/QTc Study, and the Comprehensive in vitro Proarrhythmia Assay initiative is well under way. Developments in the field of cardiovascular safety are also described and discussed in the book. These include the search for more efficient ways to exonerate new drugs for type 2 diabetes from an unacceptable cardiovascular liability, how best to address off-target blood pressure increases induced by noncardiovascular drugs, and the continued evolution of the discipline of Cardio-oncology. “a resource that will likely serve as a standard for years to come” - Dr Jonathan Seltzer Therapeutic Innovation & Regulatory Science, 2017;51(2):180 “I have no hesitation in recommending this book as a valuable reference source” - Dr Rashmi Shah Journal for Clinical Studies, 2017;9(1):62-63

Ensuring the safety of new medical products remains a major challenge for the pharmaceutical industry. Cardiac safety, particularly drug-induced heart rhythm abnormalities, remains an important cause of pipeline attrition and has resulted in countless major product recalls or label changes. The risk of encountering this major adverse event continues to shape the drug development and regulatory landscape. Extensive research over the past decade has shed light on the root causes of arrhythmias that are triggered by medications and has helped drive, and optimize, drug safety testing. However, current cardiac safety platforms have several limitations and there remains a pressing unmet need to improve the predictive power of today's drug safety tests. Fundamental to addressing the problem of drug-induced arrhythmias, and to reducing the impact of this safety signal on drug development, is a complete understanding of how these events may arise, what cardiac safety tests are currently used, and what opportunities there are to enhance patient safety and reduce the risk of detecting cardiac toxicity in later stages of product commercialization. By introducing the reader to these core concepts, this book delivers key insight into the increasingly important and dynamic field of cardiac safety.

Some drugs which are not aimed at treating heart disease have nevertheless been found to have profound effects on heart muscle. Cardiotoxicity is one of the major forms of toxicity seen in drugs and it accounts for most drug recalls and delays experienced in regulatory approvals.In recent years a number of non-cardiac blockbuster drugs such as terfenadine have been withdrawn from major markets because of cardiotoxicity concerns, while other drugs have either been withdrawn prior to marketing or required labelling changes that significantly restricted their use. In Cardiotoxicity of Non-Cardiovascular Drugs international experts describe the molecular mechanisms and clinical read-outs of cardiac events induced by a broad variety of noncardiovascular drugs. Particular emphasis is paid to the preclinical screening of drug cardiotoxicity. Topics include: metabolic targets of cardiotoxicity regulatory aspects translating molecular mechanisms into clinical trials structure-activity relationships in arrhythmias by antihistamines and psychoactive drugs cardiovascular toxicity of antitumor drugs cardiovascular toxicities of non-steroidal anti-inflammatory drugs cardiovascular toxicities of antiretroviral therapies Cardiotoxicity of Non-Cardiovascular Drugs is an essential guide to this important area of drug development. It will find a place on the bookshelves of researchers, regulators and students in medicinal chemistry, drug development, pharmacology, pharmacy and cardiovascular disease.

Cardiac Drugs describes the latest advances in the rapidly evolving area of cardiovascular pharmacology. Written by renowned, USbased experts in cardiology, this book discusses the drug groups for different diseases, such as acute coronary syndromes, hypertension, angina and heart failure. Separate chapters examine cardiac drugs in pregnancy and lactation, and future directions. Enhanced by full colour images and illustrations, this easy to follow text offers practical advice on how to manage cardiac diseases, with a focus on hands-on therapeutic guidance for clinicians.