Download or read book Pharmacoepidemiology and Therapeutic Risk Management written by Abraham G. Hartzema and published by . This book was released on 2008 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book 21st international conference on pharmacoepidemiology and therapeutic risk management written by and published by . This book was released on 2005 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Therapeutic Risk Management of Medicines written by Stephen J. Mayall and published by Elsevier. This book was released on 2014-04-16 with total page 435 pages. Available in PDF, EPUB and Kindle. Book excerpt: Therapeutic risk management of medicines is an authoritative and practical guide on developing, implementing and evaluating risk management plans for medicines globally. It explains how to assess risks and benefit-risk balance, design and roll out risk minimisation and pharmacovigilance activities, and interact effectively with key stakeholders.A more systematic approach for managing the risks of medicines arose following a number of high-profile drug safety incidents and a need for better access to effective but potentially risky treatments. Regulatory requirements have evolved rapidly over the past decade. Risk management plans (RMPs) are mandatory for new medicinal products in the EU and a Risk Evaluation and Mitigation Strategy (REMS) is needed for certain drugs in the US.This book is an easy-to-read resource that complements current regulatory guidance, by exploring key areas and practical implications in greater detail. It is structured into chapters encompassing a background to therapeutic risk management, strategies for developing RMPs, implementation of RMPs, and the continuing evolution of the risk management field.The topic is of critical importance not only to the pharmaceutical and biotechnology industries, but also regulators and healthcare policymakers.Some chapters feature contributions from selected industry experts. - An up-to-date practical guide on conceiving, designing, and implementing global therapeutic risk management plans for medicines - A number of useful frameworks are presented which add impact to RMPs (Risk Management Plans), together with regional specific information (European Union, United States, and Japan) - A comprehensive guide for performing risk management more effectively throughout a product's life-cycle
Download or read book 20th International Conference on Pharmacoepidemiology written by and published by . This book was released on 2004 with total page 349 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Abstracts of the 28th International Conference on Pharmacoepidemiology Therapeutic Risk Management 23 26 August 2012 Barcelona Spain written by and published by . This book was released on 2012 with total page 501 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book 1st International Conference on Therapeutic Risk Management 19th International Conference on Pharmacoepidemiology written by and published by . This book was released on 2003 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book 1st International Conference on Therapeutic Risk Management 19th International Conference on Pharmacoepidemiology written by and published by . This book was released on 2003 with total page 198 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Abstracts written by and published by . This book was released on 2003 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmacoepidemiology written by Brian L. Strom and published by John Wiley & Sons. This book was released on 2012-03-05 with total page 977 pages. Available in PDF, EPUB and Kindle. Book excerpt: Now in its fifth edition, Pharmacoepidemiology defines the discipline and provides the most comprehensive guidance of any book on the topic. Written by world renowned experts in the field, this valuable text surveys the research designs and sources of data available for pharmacoepidemiologic research, and provides descriptions of various automated data systems, along with the advantages and disadvantages of each. Incorporating perspectives from academia, industry and regulatory agencies, this book provides detailed insights into all aspects of pharmacoepidemiology.
Download or read book Pharmacoepidemiology written by Brian L. Strom and published by John Wiley & Sons. This book was released on 2019-12-16 with total page 1220 pages. Available in PDF, EPUB and Kindle. Book excerpt: This classic, field-defining textbook, now in its sixth edition, provides the most comprehensive guidance available for anyone needing up-to-date information in pharmacoepidemiology. This edition has been fully revised and updated throughout and continues to provide a rounded view on all perspectives from academia, industry and regulatory bodies, addressing data sources, applications and methodologies with great clarity.
Download or read book Principles and Practice of Clinical Trials written by Steven Piantadosi and published by Springer Nature. This book was released on 2022-07-19 with total page 2573 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.
Download or read book Textbook of Pharmacoepidemiology written by Brian L. Strom and published by John Wiley & Sons. This book was released on 2021-10-18 with total page 564 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmacoepidemiology originally arose from the union of the fields of clinical pharmacology and epidemiology. Pharmacoepidemiology studies the use of and the effects of medical products in large numbers of people and applies the methods of epidemiology to the content area of clinical pharmacology. This field represents the science underlying studies of the effects of medical products (such as drugs, biologicals, and devices) in real world use. Strom’s Textbook of Pharmacoepidemiology meets the increasing need for people to be trained in the field. Designed to meet the need of students, this textbook offers an approach that focuses on the core of the discipline, providing a focused educational resource for students. The book is designed for students at all levels: upper-level undergraduates, graduate students, post-doctoral fellows, and others who are learning the field. Case examples feature in most chapters, and all chapters include key points and a list of further reading. Fully revised and updated throughout, Textbook of Pharmacoepidemiology, 3rd edition is a useful introduction and resource for students of pharmacoepidemiology, both those enrolled in formal classes and those learning in “the real world,” who will respond to the challenges that they encounter.
Download or read book Understanding Pharmacoepidemiology written by Yi Yang and published by McGraw Hill Professional. This book was released on 2010-12-31 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: A concise introduction to the study of medication utilization and safety in large populations of people Understanding Pharmacoepidemiology is a clear, engagingly written roadmap to mastering the important concepts and methods of pharmacoepidemiology. It explains what pharmacoepidemiology is, how pharmacoepidemiology studies are conducted, and how to interpret findings. You will learn the importance of pharmacoepidemiology, basic terminology used in research, and the data sources, study designs, and statistical analyses employed in pharmacoepidemiology research. Upon completing Understanding Pharmacoepidemiology you will have a better understanding of how to evaluate the associations between medication utilization and outcomes. Each chapter includes these valuable learning aids: A list of learning objectives Case studies or examples Discussion questions Tables and Figures You will also find a glossary of important words and terms. The content you need to understand the concepts and methods of pharmacoepidemiology: Introduction to Pharmacoepidemiology: Principles of Epidemiology Applied to the Study of Medication Use, Study Designs in Pharmacoepidemiology: Using Secondary Data in Pharmacoepidemiology; Biostatistics and Pharmacoepidemiology: Other Methodological Issues; Evaluation of Pharmacoepidemiology Literature; Medication Utilization Patterns; Medication Safety and Pharmacovigilance; and FDA Perspectives on Post-market Drug Safety.
Download or read book Developing a Protocol for Observational Comparative Effectiveness Research A User s Guide written by Agency for Health Care Research and Quality (U.S.) and published by Government Printing Office. This book was released on 2013-02-21 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)
Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Download or read book Drug Safety written by Nigel S. B. Rawson and published by FriesenPress. This book was released on 2016-11-08 with total page 274 pages. Available in PDF, EPUB and Kindle. Book excerpt: With "Big Pharma" garnering an increasing number of negative headlines due to reports of adverse drug reactions and a surge in prescription drug addiction and overdose deaths, many people are increasingly skeptical about the safety of modern pharmaceutics and the moral integrity of the pharmaceutical industry. This book was written to provide a balanced perspective on drug safety risks. No therapeutic prescription drug is entirely risk-free. Before receiving marketing approval, new drugs go through arduous and expensive testing processes that can take up to a decade and cost over two billion dollars. While not perfect, the process is far from a "Wild West" environment where big pharmaceutical companies ride roughshod over government regulators. However, author and pharmacoepidemiologist Nigel Rawson argues, the antipathy that is common between governments, pharmaceutical industry and academic experts in Canada needs to change to an environment of collaboration and partnership to enhance our ability to respond in a timely fashion to future pharmaceutical crises. While directed mainly at students in the health sciences and pharmaceutical professionals, this book will be of interest to anyone, including lay people and policy makers, who would like to know more about the evolution of the prescription drug evaluation and risk assessment process. Although the book focuses primarily on Canada, it makes comparisons with the United States and Europe, and several of the author's recommendations for how to improve the prescription drug evaluation process are applicable worldwide.
Download or read book Medical Problems During Pregnancy written by Carolyn Bernstein and published by Springer. This book was released on 2017-01-16 with total page 201 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive, case-based title takes a practical approach to treating the pregnant patient by illustrating common and less common issues that arise during pregnancy. Outlining how difficult it often is to discern normal changes from pathological changes in the pregnant patient, Medical Problems During Pregnancy addresses not only this core dilemma but also a full array of specific, challenging issues to consider when pregnant patients present with conditions like epilepsy, hypertension, cardiac arrhythmias and renal disease – disorders requiring medication despite some risks. Although standard best practices generally determine medication use, the practicality of medication at various stages of pregnancy is highly variable. Medical Problems During Pregnancy outlines key points to consider when prescribing medication and additionally offers a range of practical suggestions that can greatly improve the physician-patient interaction. A unique and invaluable addition to the literature, Medical Problems During Pregnancy will be of great interest to practicing obstetricians, primary care clinicians, family practice physicians, nurse practitioners, and other allied health professionals.
