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.

Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development. On October 24, 2008, the IOM's Forum on Drug Discovery, Development, and Translation held "Assessing and Accelerating Development of Biomarkers for Drug Safety," a one-day workshop, summarized in this volume, on the value of biomarkers in helping to determine drug safety during development.

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

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.

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 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.

Doody Rating : 3 stars : Cardiac drugs resource endows with the latest advances in cardiovascular pharmacology. Written by experts in cardiology from world renowned institutes, equipped with global view, signifying the best possible combination of clinical and research expertise in cardiovascular pharmacology. This is a comprehensive drug resource which provides up-to-date information on one of the most rapidly changing areas of medicine. Easy to follow, providing practical advice on how to manage cardiac diseases with a focus on hands-on therapeutic guidance for the clinicians. Text talks about all of the drug-groups useful in various indications like drugs for acute coronary syndromes, dyslipidemia, hypertension, pulmonary hypertension, angina, etc. along with data from clinical trials. This book is exhaustive coverage of newly evolving co-morbid conditions with chapters on metabolic syndrome and pregnancy. Future directions: Pharmacogenomics elaborates on gene interactions with cardiovascular drugs. The unique feature of this book is the detailed discussion on the guidelines of the American College of Cardiology/American Heart Association for the use of pharmacologic agents in various clinical conditions. It is enhanced with four colour illustrations and images, illustrating the key pharmacological and physiological actions. It is useful for cardiologist, pharmacologist, physicians, clinicians and specialist.