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Stephens Detection And Evaluation Of Adverse Drug Reactions
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Book Synopsis Stephens' Detection and Evaluation of Adverse Drug Reactions by : John Talbot
Download or read book Stephens' Detection and Evaluation of Adverse Drug Reactions written by John Talbot and published by John Wiley & Sons. This book was released on 2011-12-19 with total page 751 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written with practitioners in mind, this new edition of Stephen’s Detection of Adverse Drug Reactions: Principle and Practice continues to be one of the corner stones of the pharmaceutical medicine list. The classic text covers the issues and problems involved in the detection of adverse drug reactions (ADRs) throughout the life cycle of a medicine from animal studies through to clinical trials, its introduction to the market, followed by wide clinical use, and eventual decline in use or withdrawal. The sixth edition is completely revised and updated including five new chapters on pharmacogenomics, ADRs with herbal medicines, safety of medical devices, safety issues with oncology drugs, and economic aspects of ADRs. All tables and web information needed in order to practice are included to make this sixth edition a complete primer for the new practitioner and a reference for the more experienced.
Book Synopsis Stephens' Detection of New Adverse Drug Reactions by : John Talbot
Download or read book Stephens' Detection of New Adverse Drug Reactions written by John Talbot and published by John Wiley & Sons. This book was released on 2004-03-08 with total page 776 pages. Available in PDF, EPUB and Kindle. Book excerpt: A key text for all those involved in pharmacovigilance. Detection of new adverse drug reactions is fundamental to the protection of patients from harm that may occur as a result of medication. This book explores the methods used to investigate new adverse drug reactions, discussing all elements from the scientific background and animal toxicology through to worldwide regulatory and ethical issues. Stephens' Detection of New Adverse Drug Reactions provides comprehensive and up-to-date coverage of material fundamentally important to all those active in the field, whether they work in the pharmaceutical industry, drug regulatory authorities or in academia. The fifth edition of this classic reference work includes new chapters on: * vaccine safety surveillance * managing drug safety issues with marketed products * operational aspects of drug safety function * safety of biotechnology products * future of pharmacovigilance Reviews of previous editions: "This book surpasses all its educational aims. Not only is the subject matter covered comprehensively but the material is presented in a very user-friendly manner. The editors have succeeded in producing a highly-specific, definitive reference book which doubles as a most enjoyable read." Commended by the 1999 BMA Medical Book Competition "For anyone entering the field of adverse reaction monitoring one could not wish for a better primer" International Journal of Risk and Safety in Medicine
Book Synopsis The Detection of New Adverse Drug Reactions by : M. D. B. Stephens
Download or read book The Detection of New Adverse Drug Reactions written by M. D. B. Stephens and published by Springer. This book was released on 1985-06-18 with total page 269 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Detection of New Adverse Drug Reactions by : M. D. B. Stephens
Download or read book Detection of New Adverse Drug Reactions written by M. D. B. Stephens and published by Van Nostrand Reinhold Company. This book was released on 1993 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines the drug information cycle within pharmaceutical companies and assesses existing methods of collection, storage and processing of adverse event data and outlines ways of improving the drug information cycle. It is the only reference covering the entire field of pharmacovigilance.
Book Synopsis Detection of New Adverse Drug Reactions by : M. D. B. Stephens
Download or read book Detection of New Adverse Drug Reactions written by M. D. B. Stephens and published by Stockton Press. This book was released on 1998 with total page 566 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines the drug information cycle within pharmaceutical companies and assesses existing methods of collection, storage and processing of adverse event data and outlines ways of improving the drug information cycle. It is the only reference covering the entire field of pharmacovigilance.
Book Synopsis Adverse Drug Reactions by : Christian Bénichou
Download or read book Adverse Drug Reactions written by Christian Bénichou and published by John Wiley & Sons. This book was released on 1995-01-09 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reviews the biochemical and physiological abnormalities in each of the body's organ systems, enabling investigators to decide if the problem is of drug-induced origin. Much of the material is presented as a series of observations with accompanying questions which should be addressed in order to make an accurate diagnosis. Includes useful flow charts for the management of adverse drug events and examples of specific report forms.
Book Synopsis An Introduction to Pharmacovigilance by : Patrick Waller
Download or read book An Introduction to Pharmacovigilance written by Patrick Waller and published by John Wiley & Sons. This book was released on 2017-02-14 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. This introductory guide is designed to aid the rapid understanding of the key principles of pharmacovigilance. Packed full of examples illustrating drug safety issues it not only covers the processes involved, but the regulatory aspects and ethical and societal considerations of pharmacovigilance. Covering the basics step-by-step, this book is perfect for beginners and is essential reading for those new to drug safety departments and pharmaceutical medicine students. The second edition is thoroughly revised and updated throughout and includes a new chapter on clinical aspects of pharmacovigilance.
Book Synopsis Current Challenges in Pharmacovigilance by : World Health Organization
Download or read book Current Challenges in Pharmacovigilance written by World Health Organization and published by . This book was released on 2001-01-01 with total page 381 pages. Available in PDF, EPUB and Kindle. Book excerpt: In spite of recent progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines consensus is needed on standards for many difficult aspects of day-to-day pharmacovigilance that continue to pose problems for both the pharmaceutical industry and drug regulators. The CIOMS V Working Group has generated proposals for pragmatic approaches to dealing with such issues as: classification and handling of individual safety case reports from a variety of sources (spontaneous consumer reports solicited reports literature the Internet observational studies and secondary data bases disease and other registries regulatory ADR databases and licensor-licensee interactions); new approaches to case management and regulatory reporting practices (proper clinical evaluation of cases incidental vs other events patient and reporter identifiability seriousness criteria expectedness criteria case follow-up criteria and the role and structure of case narratives); improvements and efficiencies in the format content and reporting of periodic safety update reports (PSURs) (including results of an industry survey on PSUR workloads and practices; proposals for high case volume and long time-period reports simplification of certain PSURs summary bridging reports addendum reports license renewal reports for EU and Japan dealing with old products and other technical details); determination and use of population exposure (denominator) data (sources of data and a guide to analytical approaches for a variety of circumstances).The Group has also taken stock of the current state of expedited and periodic clinical safety reporting requirements around the world with summary data on regulations from more than 60 countries. Recommendations are made for enhancing the harmonization steps already taken as a result of previous CIOMS publications and the ICH process. In addition to dealing with unfinished and unresolved issues from previous CIOMS initiatives the report covers many emerging topics such as those involving new technologies. Its 20 Appendices provide a wealth of detailed explanations and reference information. It is the most comprehensive and recent treatment of difficult pharmacovigilance issues affecting the working practices and systems of drug safety and other pharmaceutical professionals.
Book Synopsis Ethical and Scientific Issues in Studying the Safety of Approved Drugs by : Institute of Medicine
Download or read book Ethical and Scientific Issues in Studying the Safety of Approved Drugs written by Institute of Medicine and published by National Academies Press. This book was released on 2012-07-30 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.
Book Synopsis WHO Guidelines on Safety Monitoring of Herbal Medicines in Pharmacovigilance Systems by : World Health Organization
Download or read book WHO Guidelines on Safety Monitoring of Herbal Medicines in Pharmacovigilance Systems written by World Health Organization and published by . This book was released on 2004-01-01 with total page 18 pages. Available in PDF, EPUB and Kindle. Book excerpt: Safety is a fundamental principle in the privision of herbal medicines and herbal products for health care and a critical component of quality control. These guidelines provide practical technical guidance for monitoring the safety of herbal medicines with pharmacovigilance systems.
Book Synopsis Pharmacoepidemiology by : Brian L. Strom
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.
Book Synopsis Drug Utilization Research by : Monique Elseviers
Download or read book Drug Utilization Research written by Monique Elseviers and published by John Wiley & Sons. This book was released on 2016-05-31 with total page 548 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Utilization Research (DUR) is an eclectic scientific discipline, integrating descriptive and analytical methods for the quantification, understanding and evaluation of the processes of prescribing, dispensing and consumption of medicines and for the testing of interventions to enhance the quality of these processes. The discipline is closely related and linked mainly to the broader field of pharmacoepidemiology, but also to health outcomes research, pharmacovigilance and health economics. Drug Utilization Research is a unique, practical guide to the assessment and evaluation of prescribing practices and to interventions to improve the use of medicines in populations. Edited by an international expert team from the International Society for Pharmacoepidemiology (ISPE), DUR is the only title to cover both the methodology and applications of drug utilization research and covers areas such as health policy, specific populations, therapeutics and adherence.
Download or read book Drug-Induced Liver Injury written by and published by Academic Press. This book was released on 2019-07-13 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug-Induced Liver Injury, Volume 85, the newest volume in the Advances in Pharmacology series, presents a variety of chapters from the best authors in the field. Chapters in this new release include Cell death mechanisms in DILI, Mitochondria in DILI, Primary hepatocytes and their cultures for the testing of drug-induced liver injury, MetaHeps an alternate approach to identify IDILI, Autophagy and DILI, Biomarkers and DILI, Regeneration and DILI, Drug-induced liver injury in obesity and nonalcoholic fatty liver disease, Mechanisms of Idiosyncratic Drug-Induced Liver Injury, the Evaluation and Treatment of Acetaminophen Toxicity, and much more. Includes the authority and expertise of leading contributors in pharmacology Presents the latest release in the Advances in Pharmacology series
Book Synopsis Textbook of Pharmacoepidemiology by : Brian L. Strom
Download or read book Textbook of Pharmacoepidemiology written by Brian L. Strom and published by John Wiley & Sons. This book was released on 2013-05-13 with total page 756 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Textbook of Pharmacoepidemiology provides a streamlined text for evaluating the safety and effectiveness of medicines. It includes a brief introduction to pharmacoepidemiology as well as sections on data sources, methodology and applications. Each chapter includes key points, case studies and essential references. One-step resource to gain understanding of the subject of pharmacoepidemiology at an affordable price Gives a perspective on the subject from academia, pharmaceutical industry and regulatory agencies Designed for students with basic knowledge of epidemiology and public health Includes many case studies to illustrate pharmacoepidemiology in real clinical setting
Book Synopsis Guidelines for Preparing Core Clinical-safety Information on Drugs by : CIOMS Working Group III
Download or read book Guidelines for Preparing Core Clinical-safety Information on Drugs written by CIOMS Working Group III and published by World Health Organization. This book was released on 1999 with total page 98 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Statin-Associated Muscle Symptoms by : Paul D. Thompson
Download or read book Statin-Associated Muscle Symptoms written by Paul D. Thompson and published by Springer Nature. This book was released on 2020-01-25 with total page 191 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an overview of statin-associated muscle symptoms (SAMS) from clinical presentation to treatment and possible metabolic causes. It examines the risk factors, presentations, diagnosis and differential diagnosis, clinical management, and financial costs of SAMS. The book also highlights patients’ perspectives on SAMS such as the psychosocial, emotional, and societal factors influencing their perceptions and experiences. Finally, the book presents the results of observational and clinical trials on the prevalence of SAMS, clinical trials for treatments, and potential future research approaches for improving the understanding and treatment of SAMS. A key addition to the Contemporary Cardiology series, Statin-Associated Muscle Symptoms is an essential resource for physicians, medical students, residents, fellows, and allied health professionals in cardiology, endocrinology, pharmacotherapy, primary care, and health promotion and disease prevention.
Book Synopsis The Textbook of Pharmaceutical Medicine by : John P. Griffin
Download or read book The Textbook of Pharmaceutical Medicine written by John P. Griffin and published by John Wiley & Sons. This book was released on 2008-04-15 with total page 883 pages. Available in PDF, EPUB and Kindle. Book excerpt: New edition of succesful standard reference book for thepharmaceutical industry and pharmaceutical physicians! The Textbook of Pharmaceutical Medicine is the coursebookfor the Diploma in Pharmaceutical Medicine, and is used as astandard reference throughout the pharmaceutical industry. The newedition includes greater coverage of good clinical practice, acompletely revised statistics chapter, and more on safety. Coversthe course information for the Diploma in PharmaceuticalMedicine Fully updated, with new authors Greater coverage of good clinical practice and safety New chapters on regulation of medical devices in Europe andregulation of therapeutic products in Australia
