Download or read book Cardiac Drug Development Guide written by Michael K. Pugsley and published by Springer Science & Business Media. This book was released on 2008-02-06 with total page 427 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cardiac Drug Development Guide outlines, in detail, the therapeutics of cardiac medicine currently at the cutting edge of scientific research and development around the world. This volume integrates basic and clinical cardiac pharmacology by c- bining, for the first time, both classical and molecular aspects of therapeutic drug development. The chapters comprise a broad spectrum of therapeutic areas and hence involve a comprehensive discussion of molecular, biochemical, and electrophy- ological concepts based on years of in vitro as well as in vivo pharmacological st- ies. In addition, the latter part of the book includes comprehensive clinical cardiac chapters that describe important topics in molecular medicine. These chapters also discuss current clinical therapeutic trends in medicine and provide an evaluation of the efficacy of novel drugs in these areas. Cardiac Drug Development Guide has many distinctive and outstanding features that set it apart from other cardiac pharmacology books. This book introduces topics in an easily understandable format for researchers in many varying disciplines by integrating and thereby simplifying concepts not usually discussed across a broad range of cardiac disciplines and in a highly technical field. Each chapter not only introduces and describes the physiology, pharmacology, and pathophysiology of the disease, but also overviews the clinical implications of drug development, what stages these areas are currently in, and also reviews some of the methodologies involved in drug discovery and development. As a result, this book provides a comprehensive overview of the most advanced procedures in cardiac pharmacology today.
Download or read book Cardiovascular Drug Development written by John Somberg and published by CRC Press. This book was released on 1998-11-04 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: These multidisciplinary presentations provide information essential to devising effective drug protocols in cardiovascular drug development, facilitating the approval process. Guides researchers and developers through the government drug approval process, facilitating development, minimizing costs, and harmonizing international standards employed in the creation of vital new cardiovascular therapies! Cardiovascular Drug Development explores the delicate balance of efficacy and safety that cardiovascular therapy must achieve to gain regulatory approval discusses the search for surrogates and the need in some areas for natural history endpoints reviews optimum strategies for protocol design in the development of drugs to treat hypertension, cardiac arrhythmias, heart failure, coronary artery disease, and hypercholesterolemia and other lipid disorders compares and contrasts the varying standards of evidence for drug approval in the United States, Europe, and Asia and more! Cardiovascular Drug Development will prove to be a valuable asset for cardiologists, pharmacologists and pharmacists, regulatory affairs specialists, and directors of research and development for pharmaceutical companies.
Download or read book Cardiac Safety of Noncardiac Drugs written by Joel Morganroth and published by Springer Science & Business Media. This book was released on 2007-10-10 with total page 355 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Integrated Cardiac Safety written by J. Rick Turner and published by John Wiley & Sons. This book was released on 2008-11-26 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book The ESC Handbook on Cardiovascular Pharmacotherapy written by Juan Carlos Kaski and published by European Society of Cardiology. This book was released on 2019-05-23 with total page 961 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Human Genetics and Big Data to Guide Cardiovascular Drug Development written by Arjen J. Cupido and published by . This book was released on 2023 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Cardiac Drug Safety written by Matthew J. Killeen and published by World Scientific. This book was released on 2012 with total page 189 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Frontiers in Cardiovascular Drug Discovery written by Atta-ur-Rahman and published by Bentham Science Publishers. This book was released on 2016-11-01 with total page 406 pages. Available in PDF, EPUB and Kindle. Book excerpt: Frontiers in Cardiovascular Drug Discovery is an eBook series devoted to publishing the latest advances in cardiovascular drug design and discovery. Each volume brings reviews on the biochemistry, in-silico drug design, combinatorial chemistry, high-throughput screening, drug targets, recent important patents, and structure-activity relationships of molecules used in cardiovascular therapy. The eBook series should prove to be of great interest to all medicinal chemists and pharmaceutical scientists involved in preclinical and clinical research in cardiology. The third volume of the series covers the following topics: - P2Y12 receptor agonists -Heart failure pharmacotherapy -Vasopressin and the cardiovascular system -Cerebral small vessel disease -Complement blocking therapeutic strategies -New antiplatelet and anticoagulating agents for gastrointestinal treatments
Download or read book Accelerating the Development of Biomarkers for Drug Safety written by Institute of Medicine and published by National Academies Press. This book was released on 2009-07-20 with total page 101 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Cardiac Drugs written by Kanu Chatterjee and published by JP Medical Ltd. This book was released on 2012-12-30 with total page 530 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Cardiac Drugs written by Kanu Chatterjee and published by JP Medical Ltd. This book was released on 2015-08-31 with total page 552 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cardiac Drugs is the latest edition of this comprehensive resource, completely revised to provide up-to-date information on the rapidly evolving field of cardiovascular drugs. The book is divided into thirteen chapters, focusing on cardiovascular comorbid conditions, with extensive coverage of cardiovascular disease management in patients with co-existing diabetes, dysmetabolic syndrome and pregnancy. The first two chapters cover vasodilators and neurohormone modulators, and positive inotropic drugs, and subsequent chapters cover drugs for specific conditions including dyslipidemia, dysrhythmia, stable angina, and pulmonary hypertension. The final chapter ‘Future Direction – Pharmacogenomics’ provides insight into the exploration of the human genome for opportunities to improve therapeutic precision in cardiovascular medicine. This new edition of Cardiac Drugs also incorporates the latest JNC 8 (Joint National Committee) guidelines on hypertension, highlighting their key differences to previous guidelines. Enhanced by 80 full colour illustrations and tables, and written by US based experts in cardiovascular pharmacology, Cardiac Drugs is an invaluable resource for cardiologists and pharmacologists. Key Points Latest edition of comprehensive guide to cardiovascular pharmacology Incorporates JNC 8 guidelines on hypertension 80 full colour illustrations and tables Written by US based experts in the field of cardiovascular pharmacology Previous edition (9789350258798) published 2012
Download or read book Guide to Drug Development written by Bert Spilker and published by Lippincott Williams & Wilkins. This book was released on 2009 with total page 1277 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by one of the foremost authorities on clinical trials, drug development, and regulatory affairs, Guide to Drug Development is a comprehensive review of the principles and activities involved in developing new drugs, devices, and other medical products. The book covers many topics not discussed in any other textbook and includes timely discussions on electronic clinical trials, registries of clinical trials, data mining, computer simulations and modeling, and changing regulatory standards. Each chapter includes practical tips, lessons, guides, firsthand stories, quotes from experts, and three to six questions for group discussion. The last three chapters present twelve case studies each on clinical trials, regulatory affairs, and management of drug development. Spilker's Guide to Drug Development will be the standard reference text for everyone working on or studying drug discovery or development, in industry, academia, hospitals, government, and independent laboratories.
Download or read book Coronary Artery Disease Therapeutics and Drug Discovery written by Miao Wang and published by Springer Nature. This book was released on 2020-04-03 with total page 345 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an overview of the etiology of coronary artery disease and focuses on the main therapies and drug interventions currently available. It highlights drug pharmacology and therapeutic challenges, with a special emphasis on the underlying principles of available therapeutics and the on-going development of drugs for coronary artery disease. The book is divided into eight chapters, the first of which describes the classical mechanism of coronary artery disease and its clinical presentations. Chapter 2 lists the principles of and related evidence on the prevention and treatment of coronary artery disease. This includes diet and lifestyle management, and guidelines for the treatment of acute coronary syndrome and stable coronary artery disease. In turn, Chapter 3 describes revascularization treatments, covering percutaneous coronary interventions, coronary artery bypass grafts and thrombolysis. This chapter also addresses the main therapeutic challenges. The following chapters provide an overview of three major categories of coronary artery disease drugs, which target thrombosis (Chapter 4), lipid metabolism (Chapter 5), and hypertension (Chapter 6). Heart failure constitutes the major health burden in the late stage of coronary artery disease; accordingly, current heart failure therapeutics and related drug pharmacology are described in Chapter 7. In closing, Chapter 8 provides a summary of on-going clinical trials for coronary artery disease drug development and discusses a number of promising areas in which intensive research into new therapeutics is being pursued. Given its scope, the book will be of interest to clinicians, medical students and research scientists, as well as to pharmaceutical professionals who are seeking new therapies and drugs for coronary artery disease and related disorders.
Download or read book Improving and Accelerating Therapeutic Development for Nervous System Disorders written by Institute of Medicine and published by National Academies Press. This book was released on 2014-02-06 with total page 107 pages. Available in PDF, EPUB and Kindle. Book excerpt: Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.
Download or read book Handbook of Pediatric Cardiovascular Drugs written by Ricardo Munoz and published by Springer. This book was released on 2009-10-12 with total page 356 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook of drugs used in pediatric cardiac care will satisfy the need for a quick reference source of common drug therapy. There are no major texts available in the field of pediatric cardiology that exclusively provide therapeutic drug information. Several sources are available that present drug information for cardiology, but these place no emphasis on pediatric care and are written for general cardiac specialists.
Download or read book Cardiotoxicity of Non Cardiovascular Drugs written by Giorgio Minotti and published by John Wiley & Sons. This book was released on 2010-03-25 with total page 360 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Practical Considerations for Adaptive Trial Design and Implementation written by Weili He and published by Springer. This book was released on 2014-10-15 with total page 420 pages. Available in PDF, EPUB and Kindle. Book excerpt: This edited volume is a definitive text on adaptive clinical trial designs from creation and customization to utilization. As this book covers the full spectrum of topics involved in the adaptive designs arena, it will serve as a valuable reference for researchers working in industry, government and academia. The target audience is anyone involved in the planning and execution of clinical trials, in particular, statisticians, clinicians, pharmacometricians, clinical operation specialists, drug supply managers, and infrastructure providers. In spite of the increased efficiency of adaptive trials in saving costs and time, ultimately getting drugs to patients sooner, their adoption in clinical development is still relatively low. One of the chief reasons is the higher complexity of adaptive design trials as compared to traditional trials. Barriers to the use of clinical trials with adaptive features include the concerns about the integrity of study design and conduct, the risk of regulatory non-acceptance, the need for an advanced infrastructure for complex randomization and clinical supply scenarios, change management for process and behavior modifications, extensive resource requirements for the planning and design of adaptive trials and the potential to relegate key decision makings to outside entities. There have been limited publications that address these practical considerations and recommend best practices and solutions. This book fills this publication gap, providing guidance on practical considerations for adaptive trial design and implementation. The book comprises three parts: Part I focuses on practical considerations from a design perspective, whereas Part II delineates practical considerations related to the implementation of adaptive trials. Putting it all together, Part III presents four illustrative case studies ranging from description and discussion of specific adaptive trial design considerations to the logistic and regulatory issues faced in trial implementation. Bringing together the expertise of leading key opinion leaders from pharmaceutical industry, academia, and regulatory agencies, this book provides a balanced and comprehensive coverage of practical considerations for adaptive trial design and implementation.
