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 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 The ESC Handbook on Cardiovascular Pharmacotherapy written by Juan Carlos Kaski and published by . This book was released on 2019 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 drug prescribing.
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 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.
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 Acquired Long QT Syndrome written by A. John Camm and published by John Wiley & Sons. This book was released on 2008-04-15 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years there has been considerable interest in the diagnosis and understanding of ventricular repolarisation, particularly the QT interval prolongation and abnormal T and T/U wave morphology associated with torsades de pointes. Advances in ion channel cloning have greatly improved our understanding of the role of ionic channels in mediating cardiac repolarisation. Unfortunately, it is increasingly recognised that a number of drugs, both those associated with altering repolarisation, and others for non-cardiac conditions can increase the propensity for polymorphic ventricular tachycardia, syncope and even ventricular fibrillation and sudden death. In this volume, arrhythmia specialists from St. George’s Hospital Medical School, London discuss the mechanisms behind QT prolongation and torsades de pointes. They focus particularly on the risk of individual cardiac and non-cardiac drugs in provoking long QT syndrome, providing a comprehensive review which will be useful for all electrophysiologists treating polymorphic ventricular tachycardias, and will expose important regulatory issues for pharmaceutical authorities and for the wider medical community.
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 Biomarkers in Drug Development written by Michael R. Bleavins and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 559 pages. Available in PDF, EPUB and Kindle. Book excerpt: Discover how biomarkers can boost the success rate of drug development efforts As pharmaceutical companies struggle to improve the success rate and cost-effectiveness of the drug development process, biomarkers have emerged as a valuable tool. This book synthesizes and reviews the latest efforts to identify, develop, and integrate biomarkers as a key strategy in translational medicine and the drug development process. Filled with case studies, the book demonstrates how biomarkers can improve drug development timelines, lower costs, facilitate better compound selection, reduce late-stage attrition, and open the door to personalized medicine. Biomarkers in Drug Development is divided into eight parts: Part One offers an overview of biomarkers and their role in drug development. Part Two highlights important technologies to help researchers identify new biomarkers. Part Three examines the characterization and validation process for both drugs and diagnostics, and provides practical advice on appropriate statistical methods to ensure that biomarkers fulfill their intended purpose. Parts Four through Six examine the application of biomarkers in discovery, preclinical safety assessment, clinical trials, and translational medicine. Part Seven focuses on lessons learned and the practical aspects of implementing biomarkers in drug development programs. Part Eight explores future trends and issues, including data integration, personalized medicine, and ethical concerns. Each of the thirty-eight chapters was contributed by one or more leading experts, including scientists from biotechnology and pharmaceutical firms, academia, and the U.S. Food and Drug Administration. Their contributions offer pharmaceutical and clinical researchers the most up-to-date understanding of the strategies used for and applications of biomarkers in drug development.
Download or read book Principles of Safety Pharmacology written by Michael K. Pugsley and published by Springer. This book was released on 2015-06-19 with total page 477 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book illustrates, in a comprehensive manner, the most current areas of importance to Safety Pharmacology, a burgeoning unique pharmacological discipline with important ties to academia, industry and regulatory authorities. It provides readers with a definitive collection of topics containing essential information on the latest industry guidelines and overviews current and breakthrough topics in both functional and molecular pharmacology. An additional novelty of the book is that it constitutes academic, pharmaceutical and biotechnology perspectives for Safety Pharmacology issues. Each chapter is written by an expert in the area and includes not only a fundamental background regarding the topic but also detailed descriptions of currently accepted, validated models and methods as well as innovative methodologies used in drug discovery.
Download or read book Manual of Cardiovascular Medicine written by Brian P. Griffin and published by Lippincott Williams & Wilkins. This book was released on 2018-10-24 with total page 1647 pages. Available in PDF, EPUB and Kindle. Book excerpt: Publisher's Note: Products purchased from 3rd Party sellers are not guaranteed by the Publisher for quality, authenticity, or access to any online entitlements included with the product. An ideal reference for residents, fellows, practitioners, and nurse practitioners, Manual of Cardiovascular Medicine, 5th Edition is a concise, up-to-date overview of key topics in cardiology. Using a practical, outline format, this best-selling title presents evidence-based approaches to cardiovascular diagnosis, diseases, and treatment – perfect for daily practice or exam preparation.
Download or read book Pharmaceutical Medicine and Translational Clinical Research written by Divya Vohora and published by Academic Press. This book was released on 2017-11-14 with total page 527 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features.As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. - Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and - Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery
Download or read book Pathophysiology and Pharmacotherapy of Cardiovascular Disease written by Gowraganahalli Jagadeesh and published by Springer. This book was released on 2015-05-06 with total page 1323 pages. Available in PDF, EPUB and Kindle. Book excerpt: The present book covers the basic principles of cardiovascular physiology, pathophysiology and advanced pharmacology with particular emphasis on cellular mechanisms of drug action. It provides an update on the progress made in several aspects of cardiovascular diseases so that it might kindle scientists and clinicians alike in furthering basic and translational research. In addition, the book is expected to fill imperative gaps in understanding and optimally treating cardiovascular disease.
Download or read book Early Drug Development written by Mitchell N. Cayen and published by John Wiley & Sons. This book was released on 2011-02-25 with total page 507 pages. Available in PDF, EPUB and Kindle. Book excerpt: The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to support a submission to regulatory agencies.
Download or read book Commercializing Successful Biomedical Technologies written by Shreefal S. Mehta and published by Cambridge University Press. This book was released on 2008-04-24 with total page 449 pages. Available in PDF, EPUB and Kindle. Book excerpt: Successful product design and development requires the ability to take a concept and translate the technology into useful, patentable, commercial products. This book guides the reader through the practical aspects of the commercialization process of drug, diagnostic and device biomedical technology including market analysis, product development, intellectual property and regulatory constraints. Key issues are highlighted at each stage in the process, and case studies are used to provide practical examples. The book will provide a sound road map for those involved in the biotechnology industry to effectively plan the commercialization of profitable regulated medical products. It will also be suitable for a capstone design course in engineering and biotechnology, providing the student with the business acumen skills involved in product development.
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 Cardiovascular Drug Development written by John Somberg and published by CRC Press. This book was released on 1998-11-04 with total page 248 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.
