Cardiac Drug Safety

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Publisher : World Scientific
ISBN 13 : 9814317454
Total Pages : 189 pages
Book Rating : 4.8/5 (143 download)

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Book Synopsis Cardiac Drug Safety by : Matthew J. Killeen

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.

Cardiac Drug Safety: A Bench To Bedside Approach

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Publisher : World Scientific
ISBN 13 : 9814464406
Total Pages : 189 pages
Book Rating : 4.8/5 (144 download)

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Book Synopsis Cardiac Drug Safety: A Bench To Bedside Approach by : Matthew J Killeen

Download or read book Cardiac Drug Safety: A Bench To Bedside Approach written by Matthew J Killeen and published by World Scientific. This book was released on 2012-02-02 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.

Integrated Cardiac Safety

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Publisher : John Wiley & Sons
ISBN 13 : 0470411287
Total Pages : 500 pages
Book Rating : 4.4/5 (74 download)

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Book Synopsis Integrated Cardiac Safety by : J. Rick Turner

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.

Cardiac Safety of Noncardiac Drugs

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Publisher : Springer Science & Business Media
ISBN 13 : 1592598846
Total Pages : 355 pages
Book Rating : 4.5/5 (925 download)

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Book Synopsis Cardiac Safety of Noncardiac Drugs by : Joel Morganroth

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.

Cardiovascular Safety in Drug Development and Therapeutic Use

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Author :
Publisher : Springer
ISBN 13 : 3319403478
Total Pages : 350 pages
Book Rating : 4.3/5 (194 download)

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Book Synopsis Cardiovascular Safety in Drug Development and Therapeutic Use by : J. Rick Turner

Download or read book Cardiovascular Safety in Drug Development and Therapeutic Use written by J. Rick Turner and published by Springer. This book was released on 2016-07-28 with total page 350 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Cardiovascular Drug Development

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Publisher : CRC Press
ISBN 13 : 0824746317
Total Pages : 259 pages
Book Rating : 4.8/5 (247 download)

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Book Synopsis Cardiovascular Drug Development by : John Somberg

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.

Principles of Translational Science in Medicine

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Publisher : Academic Press
ISBN 13 : 0128007214
Total Pages : 365 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Principles of Translational Science in Medicine by : Martin Wehling

Download or read book Principles of Translational Science in Medicine written by Martin Wehling and published by Academic Press. This book was released on 2015-04-02 with total page 365 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principles of Translational Science in Medicine: From Bench to Bedside, Second Edition, provides an update on major achievements in the translation of research into medically relevant results and therapeutics. The book presents a thorough discussion of biomarkers, early human trials, and networking models, and includes institutional and industrial support systems. It also covers algorithms that have influenced all major areas of biomedical research in recent years, resulting in an increasing numbers of new chemical/biological entities (NCEs or NBEs) as shown in FDA statistics. The book is ideal for use as a guide for biomedical scientists to establish a systematic approach to translational medicine. Provides an in-depth description of novel tools for the assessment of translatability of trials to balance risk and improve projects at any given stage of product development New chapters deal with translational issues in the fastest growing population (the elderly), case studies, translatability assessment tools, and advances in nanotherapies Details IPR issues of translation, especially for public-private-partnerships Contains contributions from world leaders in translational medicine, including the former NIH director and authorities from various European regulatory institutions

That High Design Of Purest Gold: A Critical History Of The Pharmaceutical Industry, 1880-2020

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Publisher : World Scientific
ISBN 13 : 9811222495
Total Pages : 525 pages
Book Rating : 4.8/5 (112 download)

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Book Synopsis That High Design Of Purest Gold: A Critical History Of The Pharmaceutical Industry, 1880-2020 by : Graham Dutfield

Download or read book That High Design Of Purest Gold: A Critical History Of The Pharmaceutical Industry, 1880-2020 written by Graham Dutfield and published by World Scientific. This book was released on 2020-11-11 with total page 525 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a history of medicines and the commercial actors that make and sell them, covering the 140 years since the modern pharmaceutical industry came into being. It is written in a lively and accessible way, aiming at a general audience that combines historical narrative with fascinating case studies on drug discovery and commercialization, from the rat poison that became warfarin, to a cardiovascular treatment that was turned into Viagra. In a non-partisan way it also examines some of the less noble manifestations of corporate behavior, concluding with an agenda for reform.It is hard to think of anything nobler than to bring to the world a medicine that saves lives. And over 140 years of history, the pharmaceutical industry has produced a range of remarkable products, albeit typically with external scientific and financial support. Making medicines is a very big and profit-driven business, and the industry does not always make the right products for the right people, or at the right prices.The industry wields immense power over lives and economies. How has it risen to this position of dominance? Are the interests of the industry and the public in balance? What should we admire about the industry? What should we criticise and seek to change? The importance of this book lies in the fact that we are all stakeholders in this industry whether or not we own shares, so we all need answers to these questions.Related Link(s)

Basic Principles of Drug Discovery and Development

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Publisher : Academic Press
ISBN 13 : 0128172150
Total Pages : 712 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Basic Principles of Drug Discovery and Development by : Benjamin E. Blass

Download or read book Basic Principles of Drug Discovery and Development written by Benjamin E. Blass and published by Academic Press. This book was released on 2021-03-30 with total page 712 pages. Available in PDF, EPUB and Kindle. Book excerpt: Basic Principles of Drug Discovery and Development presents the multifaceted process of identifying a new drug in the modern era, which requires a multidisciplinary team approach with input from medicinal chemists, biologists, pharmacologists, drug metabolism experts, toxicologists, clinicians, and a host of experts from numerous additional fields. Enabling technologies such as high throughput screening, structure-based drug design, molecular modeling, pharmaceutical profiling, and translational medicine are critical to the successful development of marketable therapeutics. Given the wide range of disciplines and techniques that are required for cutting edge drug discovery and development, a scientist must master their own fields as well as have a fundamental understanding of their collaborator’s fields. This book bridges the knowledge gaps that invariably lead to communication issues in a new scientist’s early career, providing a fundamental understanding of the various techniques and disciplines required for the multifaceted endeavor of drug research and development. It provides students, new industrial scientists, and academics with a basic understanding of the drug discovery and development process. The fully updated text provides an excellent overview of the process and includes chapters on important drug targets by class, in vitro screening methods, medicinal chemistry strategies in drug design, principles of in vivo pharmacokinetics and pharmacodynamics, animal models of disease states, clinical trial basics, and selected business aspects of the drug discovery process. Provides a clear explanation of how the pharmaceutical industry works, as well as the complete drug discovery and development process, from obtaining a lead, to testing the bioactivity, to producing the drug, and protecting the intellectual property Includes a new chapter on the discovery and development of biologics (antibodies proteins, antibody/receptor complexes, antibody drug conjugates), a growing and important area of the pharmaceutical industry landscape Features a new section on formulations, including a discussion of IV formulations suitable for human clinical trials, as well as the application of nanotechnology and the use of transdermal patch technology for drug delivery Updated chapter with new case studies includes additional modern examples of drug discovery through high through-put screening, fragment-based drug design, and computational chemistry

The Role of NIH in Drug Development Innovation and Its Impact on Patient Access

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Author :
Publisher : National Academies Press
ISBN 13 : 0309498511
Total Pages : 103 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis The Role of NIH in Drug Development Innovation and Its Impact on Patient Access by : National Academies of Sciences, Engineering, and Medicine

Download or read book The Role of NIH in Drug Development Innovation and Its Impact on Patient Access written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-01-27 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.

Antitargets and Drug Safety

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Publisher : John Wiley & Sons
ISBN 13 : 3527335110
Total Pages : 524 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Antitargets and Drug Safety by : Laszlo Urban

Download or read book Antitargets and Drug Safety written by Laszlo Urban and published by John Wiley & Sons. This book was released on 2015-06-08 with total page 524 pages. Available in PDF, EPUB and Kindle. Book excerpt: With its focus on emerging concerns of kinase and GPCR-mediated antitarget effects, this vital reference for drug developers addresses one of the hot topics in drug safety now and in future. Divided into three major parts, the first section deals with novel technologies and includes the utility of adverse event reports to drug discovery, the translational aspects of preclinical safety findings, broader computational prediction of drug side-effects, and a description of the serotonergic system. The main part of the book looks at some of the most common antitarget-mediated side effects, focusing on hepatotoxicity in drug safety, cardiovascular toxicity and signaling effects via kinase and GPCR anti-targets. In the final section, several case studies of recently developed drugs illustrate how to prevent anti-target effects and how big pharma deals with them if they occur. The more recent field of systems pharmacology has gained prominence and this is reflected in chapters dedicated to the utility in deciphering and modeling anti-targets. The final chapter is concerned with those compounds that inadvertently elicit CNS mediated adverse events, including a pragmatic description of ways to mitigate these types of safety risks. Written as a companion to the successful book on antitargets by Vaz and Klabunde, this new volume focuses on recent progress and new classes, methods and case studies that were not previously covered.

Modern Methods of Clinical Investigation

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Publisher : National Academies Press
ISBN 13 : 0309042860
Total Pages : 241 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Modern Methods of Clinical Investigation by : Institute of Medicine

Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

Biomarkers in Drug Development

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Publisher : John Wiley & Sons
ISBN 13 : 1118210425
Total Pages : 559 pages
Book Rating : 4.1/5 (182 download)

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Book Synopsis Biomarkers in Drug Development by : Michael R. Bleavins

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.

Translational Research Methods in Diabetes, Obesity, and Nonalcoholic Fatty Liver Disease

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Publisher : Springer
ISBN 13 : 3030117480
Total Pages : 556 pages
Book Rating : 4.0/5 (31 download)

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Book Synopsis Translational Research Methods in Diabetes, Obesity, and Nonalcoholic Fatty Liver Disease by : Andrew J. Krentz

Download or read book Translational Research Methods in Diabetes, Obesity, and Nonalcoholic Fatty Liver Disease written by Andrew J. Krentz and published by Springer. This book was released on 2019-04-02 with total page 556 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book aims to aid the selection of the most appropriate methods for use in early phase (1 and 2) clinical studies of new drugs for diabetes, obesity, non-alcoholic fatty liver disease (NAFLD) and related cardiometabolic disorders. Clinical research methods to assess the pharmacokinetics and pharmacodynamics of new diabetes drugs, e.g. the euglycemic clamp technique, have become well-established in proof-of-mechanism studies. However, selection of the most appropriate techniques is by no means straightforward. Moreover, the application of such methods must conform to the regulatory requirements for new drugs. This book discusses the need for new pharmacotherapies for diabetes, obesity and NAFLD and the molecular targets of drugs currently in development. Emerging technologies including functional imaging, circulating biomarkers and omics are considered together with practical and ethical issues pertaining to early phase clinical trials in subjects with cardiometabolic disorders. Translational Research Methods in Diabetes, Obesity, and Non-Alcoholic Fatty Liver Disease is of interest to biomedical scientists, pharmacologists, academics involved in metabolic research and clinicians practicing in these specialties.

Cardiovascular Therapeutics E-Book

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Publisher : Elsevier Health Sciences
ISBN 13 : 1455737372
Total Pages : 833 pages
Book Rating : 4.4/5 (557 download)

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Book Synopsis Cardiovascular Therapeutics E-Book by : Elliott M. Antman

Download or read book Cardiovascular Therapeutics E-Book written by Elliott M. Antman and published by Elsevier Health Sciences. This book was released on 2012-09-17 with total page 833 pages. Available in PDF, EPUB and Kindle. Book excerpt: Manage cardiovascular problems more effectively with the most comprehensive resource available! A trusted companion to Braunwald's Heart Disease, Cardiovascular Therapeutics, 4th Edition addresses pharmacological, interventional, and surgical management approaches for each type of cardiovascular disease. This practical and clinically focused cardiology reference offers a balanced, complete approach to all of the usual and unusual areas of cardiovascular disease and specific therapies in one concise volume, equipping you to make the best choices for every patient. Consult this title on your favorite e-reader with intuitive search tools and adjustable font sizes. Elsevier eBooks provide instant portable access to your entire library, no matter what device you're using or where you're located. Understand current approaches to treating and managing cardiovascular patients for long-term health, for complex problems, and for unusual cardiac events. Benefit from the substantial experience of Elliott M. Antman, MD, Marc S. Sabatine, MD, and a host of other respected authorities, who provide practical, evidence-based rationales for all of today's clinical therapies. Expand your knowledge beyond pharmacologic interventions with complete coverage of the most effective interventional and device therapies being used today. Easily reference Braunwald's Heart Disease, 9th Edition for further information on topics of interest. Make the best use of the latest genetic and molecular therapies as well as advanced therapies for heart failure. Cut right to the answers you need with an enhanced focus on clinically relevant information and a decreased emphasis on pathophysiology. Stay current with ACC/AHA/ESC guidelines and the best ways to implement them in clinical practice. Get an enhanced visual perspective with an all-new, full-color design throughout.

Peptide Drug Discovery and Development

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 3527636749
Total Pages : 547 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis Peptide Drug Discovery and Development by : Miguel Castanho

Download or read book Peptide Drug Discovery and Development written by Miguel Castanho and published by John Wiley & Sons. This book was released on 2011-10-24 with total page 547 pages. Available in PDF, EPUB and Kindle. Book excerpt: Filling a real knowledge gap, this handbook and ready reference is both modern and forward-looking in its emphasis on the "bench to bedside" translational approach to drug development. Clearly structured into three major parts, the book stakes out the boundaries of peptide drug development in the preclinical as well as clinical stages. The first part provides a general background and focuses on the characteristic strengths and weaknesses of peptide drugs. The second section contains five cases studies of peptides from diverse therapeutic fields, and the lessons to be learned from them, while the final part looks at new targets and opportunities, discussing several drug targets and diseases for which peptide drugs are currently being developed.

Acute Heart Failure

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Publisher : Springer Science & Business Media
ISBN 13 : 1846287820
Total Pages : 922 pages
Book Rating : 4.8/5 (462 download)

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Book Synopsis Acute Heart Failure by : Alexandre Mebazaa

Download or read book Acute Heart Failure written by Alexandre Mebazaa and published by Springer Science & Business Media. This book was released on 2009-12-24 with total page 922 pages. Available in PDF, EPUB and Kindle. Book excerpt: For many years, there has been a great deal of work done on chronic congestive heart failure while acute heart failure has been considered a difficult to handle and hopeless syndrome. However, in recent years acute heart failure has become a growing area of study and this is the first book to cover extensively the diagnosis and management of this complex condition. The book reflects the considerable amounts of new data reported and many new concepts which have been proposed in the last 3-4 years looking at the epidemiology, diagnostic and treatment of acute heart failure.