The Future Of Drug Safety
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The Future Of Drug Safety
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2007-03-27
The Future Of 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 2007-03-27 with Medical categories.
In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.
Challenges For The Fda
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2007-10-02
Challenges For The Fda 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 2007-10-02 with Medical categories.
As the principal agency regulating food, drugs, medical devices, and biological products used by Americans, the U.S. Food and Drug Administration (FDA) serves one of the most critical consumer protection functions of the federal government. The FDA's reach is enormous, regulating products that represent roughly 25 percent of all consumer spending in the United States. Since 1992, however, federal funding for the agency has diminished, and the FDA's Center for Drug Evaluation and Research (CDER) currently relies on the fees it receives from the industry it regulates to fund the majority of its drug regulation functions. Prescription drug safety is receiving heightened press coverage and congressional scrutiny as a result of recent, highly publicized events, such as the recall of Vioxx because of its link to heart attacks, and the link between certain antidepressants (selective serotonin reuptake inhibitors, or SSRIs) and an increased risk of suicidal ideation in children. To address these concerns, the FDA in 2005 commissioned the Institute of Medicine (IOM) to conduct an independent assessment of the current U.S. drug safety system. In September 2006, the IOM committee released its report-The Future of Drug Safety: Promoting and Protecting the Health of the Public-which included 25 recommendations for improving the system for drug safety review. The committee identified four major vulnerabilities in the U.S. drug safety system: (1) chronic underfunding; (2) organization problems, particularly inadequate integration of pre-and postmarket data review; (3) a range of technical problems related to the insufficient quantity and quality of postmarket data and inadequate capability to systematically monitor the risks and benefits of drugs after marketing; and (4) unclear regulatory authority and insufficiently flexible regulatory tools. Since the IOM report was issued, the FDA has taken a number of steps toward implementing the recommended improvements. Like many government agencies, however, the FDA is financially strained by its existing responsibilities, and fully implementing the recommended improvements to the drug safety system would require significant financial commitments.The IOM report addressed some of the costs associated with its recommendations, but left many unanswered questions about the resources required to fully achieve the envisioned improvements. To better understand the types and magnitude of resources required to achieve the goals of the IOM report, the IOM's Forum on Drug Discovery, Development, and Translation convened a 1-day symposium in March 2007. Challenges for the FDA: The Future of Drug Safety, Workshop Summary explains the presentations and discussions in seven key areas: addressing the FDA's resource challenges; strengthening the scientific base of the agency; integrating pre- and postmarket review; enhancing postmarket safety monitoring; conducting confirmatory drug safety and efficacy studies; enhancing the value of clinical trial registration; and enhancing the FDA's postmarket regulation and enforcement.
New Insights Into The Future Of Pharmacoepidemiology And Drug Safety
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Author : Maria Teresa Herdeiro
language : en
Publisher: BoD – Books on Demand
Release Date : 2021-10-13
New Insights Into The Future Of Pharmacoepidemiology And Drug Safety written by Maria Teresa Herdeiro and has been published by BoD – Books on Demand this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-10-13 with Medical categories.
In the last decade, pharmacoepidemiology has emerged as an important field to study the use/effects of drugs in large populations in real life, allowing for improved benefits and effectiveness of drugs as well as a decline in drug-related risks. The correct assessment, reporting, monitoring, and prevention of adverse events in drugs’ development, as well as therapy and post-market surveillance, is essential to improve clinical therapies and health outcomes. This book provides a comprehensive and unique overview of the relevance, new insights, and recent findings of pharmacoepidemiology and drug safety in public health.
The Future Of Drug Safety Promoting And Protecting The Health Of The Public
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Author :
language : en
Publisher:
Release Date : 2007
The Future Of Drug Safety Promoting And Protecting The Health Of The Public written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007 with Drugs categories.
Technology For Drug Safety
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Author : Yaser Mohammed Al-Worafi
language : en
Publisher:
Release Date : 2023
Technology For Drug Safety written by Yaser Mohammed Al-Worafi and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023 with categories.
This book presents information about the use of technology to support the prevention and management of drug safety issues: pharmacovigilance (PV), medication errors, drug-related problems (DRPs), counterfeit medicines and other drug safety issues. Adapting new technologies/information technologies, mobile technologies and social media has contributed effectively to safety practices for medications, with this book providing comprehensive information as a guide to its challenges and potential. Technology for Drug Safety provides practicing and trainee pharmacists, pharmacy technicians, pharmacy educators, researchers, public health policy makers, healthcare professionals and medical educators with vital information about the impact of technology on drug safety-related issues. It describes the current status of the practice, the challenges in the field and recommendations for the effective use of technology in drug safety practice including clinical trials and drug development, PV, detection of adverse drug reactions, reporting and management, medication errors detection, reporting and management, DRPs, counterfeit and substandard medications, and other safety issues.
Accelerating The Development Of Biomarkers For Drug Safety
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2009-07-20
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 2009-07-20 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.
Drug Safety Specialist The Comprehensive Guide
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Author : Viruti Shivan
language : en
Publisher: Independently Published
Release Date : 2023-12-27
Drug Safety Specialist The Comprehensive Guide written by Viruti Shivan and has been published by Independently Published this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-12-27 with Medical categories.
"Drug Safety Specialist - The Comprehensive Guide" is an essential resource for anyone involved in or aspiring to a career in drug safety and pharmacovigilance. This comprehensive guide delves into the core aspects of drug safety, providing readers with a detailed understanding of the role, responsibilities, and impact of drug safety specialists in the pharmaceutical industry. Key Features: - In-Depth Knowledge: Gain a thorough understanding of drug safety principles, including adverse event reporting, risk management, and regulatory compliance. - Career Advancement: Learn about the qualifications, skills, and career paths available in this dynamic field. - Regulatory Landscape: Stay updated with the latest global regulations and guidelines from agencies like the FDA, EMA, and WHO. - Real-World Case Studies: Engage with practical examples and scenarios faced by drug safety professionals. - Expert Insights: Benefit from interviews and advice from leading experts in pharmacovigilance. - Ethical Considerations: Explore the ethical dimensions and patient safety concerns in drug development and surveillance. - Future Trends: Understand the impact of emerging technologies and trends shaping the future of drug safety. Whether you're a student, a new entrant, or an experienced professional in the pharmaceutical industry, this guide is an invaluable tool for mastering the complexities of drug safety and making a meaningful impact in the field of healthcare.
Predictive Toxicology In Drug Safety
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Author : Jinghai J. Xu
language : en
Publisher: Cambridge University Press
Release Date : 2010-09-27
Predictive Toxicology In Drug Safety written by Jinghai J. Xu and has been published by Cambridge University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-09-27 with Medical categories.
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.
Improving Drug Safety A Joint Responsibility
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Author : Rolf Dinkel
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-03-07
Improving Drug Safety A Joint Responsibility written by Rolf Dinkel 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 2013-03-07 with Medical categories.
As the focus on pharmaceuticals has broadened from concern for their cost and effectiveness to their real and potential risks and benefits, a critical question has been raised: whose responsibility is it to improve drug safety? In April 1990, this question became the theme for a conference at Wolfsberg, Switzerland, near the shores of Lake Constance. Called an "international dialogue conference" by its organizers, the meeting brought together leaders from the pharmaceutical industry, regulatory authorities, academia, medicine, consumer organizations and the media. Opening addresses were given by representatives of the Council for International Organizations of Medical Sciences (CIOMS), the International Federation of Pharmaceutical Manufacturers Associations (IFPMA), the Swiss International Pharmaceutical Agency, and the RAD-AR Consortium. This book documents the papers presented and discussions held at this conference, which took the topic of risks and benefits of drug therapy one step further to responsibility. It includes a rich menu of issues for those who care about the evaluation of drug therapy, the ethics behind it, the expectations of the patient, and the role of traditional and nontraditional drug safety communica tions. The ideas expressed here come from different parts of the world but relate to common drug safety problems, observations, and scientific assessments; they provide insights into innovative approaches, cautious changes, and desired actions. The papers in this volume are broadly divided into conceptual perspectives (ethics, how the knowledge about drug risks and benefits is generated and appraised, the expectations in drug safety) and operational perspectives (communication, discussion, and action).
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.
At present, over 120 medications have been withdrawn from the major global pharmaceutical markets due to potentially lethal unwanted effects on the heart, namely ventricular fibrillation. With recent FDA guidelines recommending stringent testing of new pharmaceuticals on the heart, the importance of cardiac electrophysiology is affecting an increasing number of professionals in a range of industries. This book will equip readers with a clear and solid foundation in the fundamentals of electrophysiology and pharmacology of the heart, explore clinical disorders and treatments and relate this to the research and development of new medicines.Representing an integrative bench to bedside approach to understanding this critical drug safety phenomenon, this book begins with a comprehensive review of the mechanisms responsible for drug-induced arrhythmia, followed by an in-depth discussion of the current preclinical and clinical recording techniques. Additionally, a complete assessment of current methods to stratify cardiac risk in drug development is included. Most importantly, the book develops and outlines the novel strategies and key frameworks that increase the cardiac drug safety and drive down the risk of novel biopharmaceutical products in the future. Contents: Physiology of the Heart; Introduction to Electrophysiology: History, Ion Channels, Important Concepts; Electrophysiology of the Heart; Studying Cardiac Electrophysiology in the Laboratory and Clinic; Electrical Disorders of the Heart: From Cell to Bedside; The Impact of Cardiac Electrophysiology on Drug Development: History, Current Tests (Regulations, Requirements) and Their Shortcomings; Case Studies; The Future of Cardiac Drug Safety: Strategies to Reduce Risk and Ensure Continued Safety.