Cardiovascular Safety in Drug Development and Therapeutic Use

Cardiovascular Safety in Drug Development and Therapeutic Use

Author: J. Rick Turner

Publisher: Springer

Published: 2016-07-28

Total Pages: 342

ISBN-13: 3319403478

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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


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

Integrated Cardiac Safety

Integrated Cardiac Safety

Author: J. Rick Turner

Publisher: John Wiley & Sons

Published: 2008-11-26

Total Pages: 500

ISBN-13: 0470411287

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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 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

Cardiac Safety of Noncardiac Drugs

Author: Joel Morganroth

Publisher: Springer Science & Business Media

Published: 2007-10-10

Total Pages: 362

ISBN-13: 1592598846

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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 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.

Cardiac Drug Safety

Cardiac Drug Safety

Author: Matthew J. Killeen

Publisher: World Scientific

Published: 2012

Total Pages: 189

ISBN-13: 9814317454

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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.


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.

Cardiovascular Drug Development

Cardiovascular Drug Development

Author: John Somberg

Publisher: CRC Press

Published: 1998-11-04

Total Pages: 259

ISBN-13: 0824746317

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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.


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 Safety Pharmacology

Principles of Safety Pharmacology

Author: Michael K. Pugsley

Publisher: Springer

Published: 2015-06-19

Total Pages: 481

ISBN-13: 366246943X

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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.


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.

Cardiac Drug Development Guide

Cardiac Drug Development Guide

Author: Michael K. Pugsley

Publisher: Springer Science & Business Media

Published: 2008-02-06

Total Pages: 427

ISBN-13: 1592594042

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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.


Book Synopsis Cardiac Drug Development Guide by : Michael K. Pugsley

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.

Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays

Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays

Author: H. Gerhard Vogel

Publisher: Springer

Published: 2013-02-27

Total Pages: 0

ISBN-13: 9783642252396

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-A landmark in the continuously changing world of drugs -Essential reading for scientists and managers in the pharmaceutical industry involved in drug finding, drug development and decision making in the development process -Of use for government institutions and committees working on official guidelines for drug evaluation worldwide


Book Synopsis Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays by : H. Gerhard Vogel

Download or read book Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays written by H. Gerhard Vogel and published by Springer. This book was released on 2013-02-27 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: -A landmark in the continuously changing world of drugs -Essential reading for scientists and managers in the pharmaceutical industry involved in drug finding, drug development and decision making in the development process -Of use for government institutions and committees working on official guidelines for drug evaluation worldwide

Frontiers in Cardiovascular Drug Discovery

Frontiers in Cardiovascular Drug Discovery

Author: Atta-ur-Rahman

Publisher: Bentham Science Publishers

Published: 2016-11-01

Total Pages: 406

ISBN-13: 1681081636

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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


Book Synopsis Frontiers in Cardiovascular Drug Discovery by : Atta-ur-Rahman

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

Key Statistical Concepts in Clinical Trials for Pharma

Key Statistical Concepts in Clinical Trials for Pharma

Author: J. Rick Turner

Publisher: Springer Science & Business Media

Published: 2011-10-14

Total Pages: 66

ISBN-13: 1461416620

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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 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.