Cardiovascular Safety In Drug Development And Therapeutic Use
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Cardiovascular Safety In Drug Development And Therapeutic Use
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Author : J. Rick Turner
language : en
Publisher: Springer
Release Date : 2016-07-28
Cardiovascular Safety In Drug Development And Therapeutic Use written by J. Rick Turner and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-07-28 with Medical categories.
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
Integrated Cardiac Safety
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Author : J. Rick Turner
language : en
Publisher: John Wiley & Sons
Release Date : 2008-11-26
Integrated Cardiac Safety written by J. Rick Turner and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-11-26 with Medical categories.
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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Author : Joel Morganroth
language : en
Publisher: Springer Science & Business Media
Release Date : 2007-10-10
Cardiac Safety Of Noncardiac Drugs written by Joel Morganroth and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-10-10 with Medical categories.
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.
Cardiac Drug Safety
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Author : Matthew J. Killeen
language : en
Publisher: World Scientific
Release Date : 2012
Cardiac Drug Safety written by Matthew J. Killeen and has been published by World Scientific this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012 with Medical categories.
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.
Cardiovascular Drug Development
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Author : John Somberg
language : en
Publisher: CRC Press
Release Date : 1998-11-04
Cardiovascular Drug Development written by John Somberg and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1998-11-04 with Medical categories.
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.
New Drug Development
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Author : J. Rick Turner
language : en
Publisher: Springer Science & Business Media
Release Date : 2010-07-16
New Drug Development written by J. Rick Turner and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-07-16 with Medical categories.
New Drug Development: Second Edition provides an overview of the design concepts and statistical practices involved in therapeutic drug development. This wide spectrum of activities begins with identifying a potentially useful drug candidate that can perhaps be used in the treatment or prevention of a condition of clinical concern, and ends with marketing approval being granted by one or more regulatory agencies. In between, it includes drug molecule optimization, nonclinical and clinical evaluations of the drug’s safety and efficacy profiles, and manufacturing considerations. The more inclusive term lifecycle drug development can be used to encompass the postmarketing surveillance that is conducted all the time that a drug is on the market and being prescribed to patients with the relevant clinical condition. Information gathered during this time can be used to modify the drug (for example, dose prescribed, formulation, and mode of administration) in terms of its safety and its effectiveness. The central focus of the first edition of this book is captured by its subtitle, 'Design, Methodology, and Analysis'. Optimum quality study design and experimental research methodology must be employed if the data collected—numerical representations of biological information—are to be of optimum quality. Optimum quality data facilitate optimum quality statistical analysis and interpretation of the results obtained, which in turn permit optimum quality decisions to be made: Rational decision making is predicated on appropriate research questions and optimum quality numerical information. The book took a non-computational approach to statistics, presenting instead a conceptual framework and providing readers with a sound working knowledge of the importance of design, methodology, and analysis. Not everyone needs to be an expert in statistical analysis, but it is very helpful for work (or aspire to work) in the pharmaceutical and biologics industries to be aware of the fundamental importance of a sound scientific and clinical approach to the planning, conduct, and analysis of clinical trials.
Key Statistical Concepts In Clinical Trials For Pharma
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Author : J. Rick Turner
language : en
Publisher: Springer Science & Business Media
Release Date : 2011-10-14
Key Statistical Concepts In Clinical Trials For Pharma written by J. Rick Turner and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-10-14 with Medical categories.
This Brief discusses key statistical concepts that facilitate the inferential analysis of data collected from a group of individuals participating in a pharmaceutical clinical trial, the estimation of their clinical significance in the general population of individuals likely to be prescribed the drug if approved, and the related decision-making that occurs at both the public health level (by regulatory agencies when deciding whether or not to approve a new drug for marketing) and the individual patient level (by physicians and their patients when deciding whether or not the patient should be prescribed a drug that is on the market). These concepts include drug safety and efficacy, statistical significance, clinical significance, and benefit-risk balance.
Quantitative Evaluation Of Safety In Drug Development
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Author : Qi Jiang
language : en
Publisher: CRC Press
Release Date : 2014-12-08
Quantitative Evaluation Of Safety In Drug Development written by Qi Jiang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-12-08 with Mathematics categories.
State-of-the-Art Methods for Drug Safety Assessment Responding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product development. It presents the latest statistical methods for drug safety assessment. The book’s three sections focus on study design, safety monitoring, and data evaluation/analysis. The book addresses key challenges across regulatory agencies, industry, and academia. It discusses quantitative approaches to safety evaluation and risk management in drug development, covering Bayesian methods, effective safety graphics, and risk-benefit evaluation. Written by a team of experienced leaders, this book brings the most advanced knowledge and statistical methods of drug safety to the statistical, clinical, and safety community. It shares best practices and stimulates further research and methodology development in the drug safety area.
Cardiac Drug Development Guide
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Author : Michael K. Pugsley
language : en
Publisher: Springer Science & Business Media
Release Date : 2008-02-06
Cardiac Drug Development Guide written by Michael K. Pugsley and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-02-06 with Medical categories.
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.
Accelerating The Development Of Biomarkers For Drug Safety
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2009-08-20
Accelerating The Development Of Biomarkers For Drug Safety written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-08-20 with Medical categories.
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.