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Integrated Cardiac Safety
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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.
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 342 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
Download or read book Predictive ADMET written by Jianling Wang and published by John Wiley & Sons. This book was released on 2014-02-28 with total page 604 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book helps readers integrate in silico, in vitro, and in vivo ADMET (absorption, distribution, metabolism, elimination and toxicity) and PK (pharmacokinetics) data with routine testing applications so that pharmaceutical scientists can diagnose ADMET problems and present appropriate recommendations to move drug discovery programs forward. The book introduces the current clinical practice for drug discovery and development along with the impact on early risk assessment; consolidates the tools and models to intelligently integrate existing in silico, in vitro and in vivo ADMET data; and demonstrates successful cases and lessons learned from real drug discovery and development. In short, it is a book aimed to provide a practical road map for drug discovery and development scientists to generate efficacious and safe drugs for unmet medical needs.
Book Synopsis Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional by : Raymond A. Huml
Download or read book Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional written by Raymond A. Huml and published by Springer Science & Business Media. This book was released on 2012-06-15 with total page 94 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Brief defines competitive intelligence (CI) as a tool for making investment decisions within the pharmaceutical industry. It provides an overview of processes that the regulatory affairs professional must take into account when evaluating data impacting product-based risk evaluations. These apply particularly to evaluations that focus on outputs such as regulatory approval, or the commercial impact of product labeling on the sales forecast over a limited timeframe. The Brief also provides an overview of intellectual property assessment that can impact a product’s lifespan on the market due to patent protection itself (or loss of patent protection) or via regulatory exclusivity. Case examples are discussed to illustrate the importance of keeping up with the ever-changing regulations, and how to interpret them in the context of CI. In addition, there is a section on virtual data rooms (VDRs) which currently function as the cornerstone of due diligence investigations. While aimed primarily at regulatory affairs professionals in the United States, this publication provides a useful adjunct for other pharmaceutical executives, especially those new to product-based investments, and regulatory affairs professionals in other regions.
Book Synopsis Integrative Computational Modeling of Calcium Handling and Cardiac Arrhythmias by : Henry Sutanto
Download or read book Integrative Computational Modeling of Calcium Handling and Cardiac Arrhythmias written by Henry Sutanto and published by Henry Sutanto. This book was released on 2021-01-01 with total page 350 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cardiomyocyte calcium handling is a major determinant of excitation-contraction coupling. Alterations in one or more calcium-handling proteins may induce arrhythmias through the formation of ectopic activity, direct and indirect ion-channel regulation, and structural remodeling. Due to the complex and tight interactions between calcium and other molecules within a cardiomyocyte, it remains experimentally challenging to study the exact contributions of calcium-handling abnormalities to arrhythmogenesis. Multiscale computational studies performed in close collaboration with laboratory experiments create new opportunities to unravel the mechanisms of arrhythmogenesis. This thesis describes the roles of integrative computational modeling in unraveling the arrhythmogenic consequences of calcium-handling abnormalities.
Book Synopsis Plunkett's Biotech & Genetics Industry Almanac by : Jack W. Plunkett
Download or read book Plunkett's Biotech & Genetics Industry Almanac written by Jack W. Plunkett and published by Plunkett Research, Ltd.. This book was released on 2008-09 with total page 602 pages. Available in PDF, EPUB and Kindle. Book excerpt: A complete market research guide to the business of biotech, genetics, proteomics and related services--a tool for strategic planning, competitive intelligence, employment searches, or financial research. Complete profiles of nearly 400 leading biotech companies, in-depth chapters on trends. Includes glossary thorough indexes, statistics, research and development, emerging technology--as well a addresses, phone numbers, and executive names.
Book Synopsis Methods and applications in integrative physiology by : Ovidiu Constantin Baltatu
Download or read book Methods and applications in integrative physiology written by Ovidiu Constantin Baltatu and published by Frontiers Media SA. This book was released on 2023-01-04 with total page 190 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Research Topic is part of the Methods and Applications in Physiology series. Other titles in this series are: • Methods and Applications in Aquatic Physiology • Methods and Applications in Clinical and Translational Physiology • Methods and Applications in Computational Physiology and Medicine • Methods and Applications in Environmental, Aviation and Space Physiology • Methods and Applications in Exercise Physiology • Methods and Applications in Fractal Physiology • Methods and Applications in Invertebrate Physiology • Methods and Applications in Metabolic Physiology • Methods and Applications in Physio-logging • Methods and Applications in Striated Muscle Physiology • Methods and Applications in Respiratory Physiology • Methods and Applications in Vascular Physiology • New Methods for Red Blood Cell Research and Diagnosis, Volume II • Combining Computational and Experimental Approaches to Characterize Ion Channels and Transporters
Book Synopsis Predictive Toxicology in Drug Safety by : Jinghai J. Xu
Download or read book Predictive Toxicology in Drug Safety written by Jinghai J. Xu and published by Cambridge University Press. This book was released on 2010-09-27 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: According to the Institute of Medicine (IOM) and U.S. Food and Drug Administration (FDA), 'developing new scientific approaches to detecting, understanding, predicting and preventing adverse events' was a critical path to the future of drug safety. This book brings together a collection of state-of-the-art chapters, written by experts in the drug safety field. It provides information on the present knowledge of drug side effects and their mitigation strategy during drug discovery, gives guidance for risk assessment and promotes evidence-based toxicology. Each specific area of toxicology relevant for drug discovery is discussed in detail, including theory, experimental approaches and data interpretation supported by comprehensive up-to-date references. Many chapters provide fascinating case studies, which are of general interest for those who have basic science training and are interested in how chemicals interact with the human body.
Book Synopsis Diseases of the Aorta by : Robert S. Dieter
Download or read book Diseases of the Aorta written by Robert S. Dieter and published by Springer Nature. This book was released on 2019-08-27 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines various aspects of the aorta, both healthy and diseased states, in 40 chapters of in-depth research by experts in cardiovascular disease. It begins with chapters on the embryology, anatomy, genetics, and physiology of the aorta along with imaging studies used to visualize its structure. The bulk of the book focuses on acute and chronic disorders such as coarctation of the aorta, inflammatory and connective tissue disorders, acute aortic thrombosis, infections, tumors, related ocular diseases, and various aneurysms and fistulas. In addition, it explores aortic disease in pregnancy, fetal aortic disorders, and aortic trauma in children. The book highlights the epidemiology and natural history as well as medical, endovascular, and surgical treatments for each disease. It also discusses valve repair, 3D printing applications, and the role of multidisciplinary aortic centers. Diseases of the Aorta is an indispensable and authoritative resource for cardiologists, cardiovascular surgeons, interventional radiologists, radiologists, and vascular medicine specialists.
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 2015-02-23 with total page 528 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.
Book Synopsis Key Statistical Concepts in Clinical Trials for Pharma by : J. Rick Turner
Download or read book Key Statistical Concepts in Clinical Trials for Pharma written by J. Rick Turner and published by Springer Science & Business Media. This book was released on 2011-10-14 with total page 66 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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 362 pages. Available in PDF, EPUB and Kindle. Book excerpt: Text and photographs present an introduction to the dog breed known as the labrador retriever, including its growth from puppy to adult, and pet care information.
Book Synopsis New Drug Development by : J. Rick Turner
Download or read book New Drug Development written by J. Rick Turner and published by Springer Science & Business Media. This book was released on 2010-07-16 with total page 269 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Integrative Cardiology by : Stephen Devries
Download or read book Integrative Cardiology written by Stephen Devries and published by OUP USA. This book was released on 2011-02-03 with total page 345 pages. Available in PDF, EPUB and Kindle. Book excerpt: Integrative Cardiology is an exploration of a new and much-needed perspective in cardiac care: the intelligent synthesis of conventional medicine with alternative approaches not typically part of Western medical curriculum. More than a blending of two approaches, this new perspective in cardiology highlights specific gaps in conventional heart care, and examines how alternative approaches may be ideally suited to address these missed opportunities.Cardiology is an ideal specialty for an integrative approach. Heart disease is largely preventable. The influence of nutrition, physical activity, metabolic factors, and emotional state on heart health is unmistakable, and the wide-angle lens of integrative medicine is an ideal model to address these multi-faceted needs. Most importantly, the focus of this work is directed at prevention. The approaches described in this book emphasize collaboration of the patient and health care provider--both seeking to obtain the best possible outcome taking into account the intangible, but vital, nuances of the patient's culture, beliefs, and preferences.The first section in this book describes the core elements of integrative cardiology, beginning with nutrition. Foundational chapters that follow include exercise, botanicals, aspirin, metabolic cardiology, acupuncture, spirituality, mind/body approaches, and energy medicine. Contributing authors, all of whom have a background in academic medicine, share the approaches they have found most effective in their own practices, referencing their work with the best scientific evidence available.
Book Synopsis A Comprehensive Guide to Toxicology in Preclinical Drug Development by : Ali S. Faqi
Download or read book A Comprehensive Guide to Toxicology in Preclinical Drug Development written by Ali S. Faqi and published by Academic Press. This book was released on 2012-11-02 with total page 904 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Comprehensive Guide to Toxicology in Preclinical Drug Development is designed for toxicologists who need a thorough understanding of the drug development process. This multi-contributed reference will provide a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics --
Book Synopsis Cardiac Repolarization by : Nabil El-Sherif
Download or read book Cardiac Repolarization written by Nabil El-Sherif and published by Springer Nature. This book was released on 2019-08-29 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive, up-to-date overview of clinical and research aspects of cardiac repolarization geared toward practicing cardiologists and physicians. It analyzes elements of pathophysiology and molecular biology as they relate to the clinical aspects of cardiac repolarization, long QT syndromes, early repolarization syndromes, and special cardiac repolarization syndromes. Each chapter examines different aspects of the field with basic and clinical overviews and highlights the impact on medical management. The book covers a variety of repolarization topics including the influence of the autonomic system, racial and gender differences in patients, the future role of stem cells, inflammation and autoimmunity, and cardiovascular risk. Cardiac Repolarization: Basic Science and Clinical Management is an essential resource for physicians and related professionals, residents, fellows, and graduate students in cardiology, clinical cardiac electrophysiology, internal medicine, and cardiovascular biology.
Book Synopsis Principles of Safety Pharmacology by : Michael K. Pugsley
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 481 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.
