Mann S Pharmacovigilance

Author : Elizabeth B. Andrews,Nicholas Moore
Publisher : John Wiley & Sons
Page : 878 pages
File Size : 47,9 Mb
Release : 2014-06-23
Category : Medical
ISBN : 9780470671047

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Mann's Pharmacovigilance by Elizabeth B. Andrews,Nicholas Moore Pdf

Highly Commended at the BMA Medical Book Awards 2015 Mann’s Pharmacovigilance is the definitive reference for the science of detection, assessment, understanding and prevention of the adverse effects of medicines, including vaccines and biologics. Pharmacovigilance is increasingly important in improving drug safety for patients and reducing risk within the practice of pharmaceutical medicine. This new third edition covers the regulatory basis and the practice of pharmacovigilance and spontaneous adverse event reporting throughout the world. It examines signal detection and analysis, including the use of population-based databases and pharmacoepidemiological methodologies to proactively monitor for and assess safety signals. It includes chapters on drug safety practice in specific organ classes, special populations and special products, and new developments in the field. From an international team of expert editors and contributors, Mann’s Pharmacovigilance is a reference for everyone working within pharmaceutical companies, contract research organisations and medicine regulatory agencies, and for all researchers and students of pharmaceutical medicine. The book has been renamed in honor of Professor Ronald Mann, whose vision and leadership brought the first two editions into being, and who dedicated his long career to improving the safety and safe use of medicines.

Author : Elizabeth B. Andrews,Nicholas Moore
Publisher : Unknown
Page : 876 pages
File Size : 52,6 Mb
Release : 2014
Category : Drug-Related Side Effects and Adverse Reactions
ISBN : OCLC:969519219

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Mann's Pharmacovigilance by Elizabeth B. Andrews,Nicholas Moore Pdf

Author : Ronald D. Mann
Publisher : Unknown
Page : 128 pages
File Size : 45,8 Mb
Release : 2019
Category : Electronic
ISBN : 1789857600

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Pharmacovigilance by Ronald D. Mann Pdf

Author : Ronald D. Mann,Elizabeth B. Andrews
Publisher : John Wiley & Sons
Page : 709 pages
File Size : 52,6 Mb
Release : 2007-02-06
Category : Medical
ISBN : 9780470059227

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Pharmacovigilance by Ronald D. Mann,Elizabeth B. Andrews Pdf

Written by an international team of outstanding editors andcontributors, Pharmacovigilance, 2ndEdition is the definitive text on this importantsubject. The new edition has been completely revised andupdated to include the latest theoretical and practical aspects ofpharmacovigilance including legal issues, drug regulatoryrequirements, methods of signal generation, reporting schemes andpharmacovigilance in selected system-organ classes. . The editors and contributors are of excellent standing withinthe pharmacovigilance community The text provides exemplary coverage of all the relevantissues The definitive book on the subject

Author : Patrick Waller,Mira Harrison-Woolrych
Publisher : John Wiley & Sons
Page : 192 pages
File Size : 51,5 Mb
Release : 2017-02-14
Category : Medical
ISBN : 9781119289784

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An Introduction to Pharmacovigilance by Patrick Waller,Mira Harrison-Woolrych Pdf

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.

Author : M. D. B. Stephens,J. C. C. Talbot
Publisher : Springer
Page : 269 pages
File Size : 45,9 Mb
Release : 1985-06-18
Category : Medical
ISBN : 9781349072507

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The Detection of New Adverse Drug Reactions by M. D. B. Stephens,J. C. C. Talbot Pdf

Author : Council for International Organizations of Medical Sciences (CIOMS)
Publisher : Cioms
Page : 0 pages
File Size : 50,6 Mb
Release : 2010
Category : Drug monitoring
ISBN : 9290360828

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Practical Aspects of Signal Detection in Pharmacovigilance by Council for International Organizations of Medical Sciences (CIOMS) Pdf

In recent years public expectations for rapid identification and prompt management of emerging drug safety issues have grown swiftly. Over a similar timeframe, the move from paper-based adverse event reporting systems to electronic capture and rapid transmission of data has resulted in the accrual of substantial datasets capable of complex analysis and querying by industry, regulators and other public health organizations. These two drivers have created a fertile environment for pharmacovigilance scientists, information technologists and statistical experts, working together, to deliver novel approaches to detect signals from these extensive and quickly growing datasets, and to manage them appropriately. In following this exciting story, this report looks at the practical consequences of these developments for pharmacovigilance practitioners. The report provides a comprehensive resource for those considering how to strengthen their pharmacovigilance systems and practices, and to give practical advice. But the report does not specify instant solutions. These will inevitably be situation specific and require careful consideration taking into account local needs. However, the CIOMS Working Group VIII is convinced that the combination of methods and a clear policy on the management of signals will strengthen current systems. Finally, in looking ahead, the report anticipates a number of ongoing developments, including techniques with wider applicability to other data forms than individual case reports. The ultimate test for pharmacovigilance systems is the demonstration of public health benefit and it is this test which signal detection methodologies need to meet if the expectations of all stakeholders are to be fulfilled.

Author : Lionel D. Edwards,Andrew J. Fletcher,Anthony W. Fox,Peter D. Stonier
Publisher : John Wiley & Sons
Page : 780 pages
File Size : 50,9 Mb
Release : 2007-04-30
Category : Medical
ISBN : 0470093145

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Principles and Practice of Pharmaceutical Medicine by Lionel D. Edwards,Andrew J. Fletcher,Anthony W. Fox,Peter D. Stonier Pdf

The long awaited second edition of Principles and Practice of Pharmaceutical Medicine provides an invaluable guide to all areas of drug development and medical aspects of marketing. The title has been extensively revised and expanded to include the latest regulatory and scientific developments. New chapters include: European Regulations Ethics of Pharmaceutical Medicine Licensing and Due Diligence Pharmacogenomics Encompassing the entire spectrum of pharmaceutical medicine, it is the most up-to-date international guide currently available. Review of the first edition: “This book was a joy to read and a joy to review. All pharmaceutical physicians should have a copy on their bookshelves, all pharmaceutical companies should have copies in their libraries.” —BRITISH ASSOCIATION OF PHARMACEUTICAL PHYSICIANS

Author : Brian L. Strom,Stephen E. Kimmel,Sean Hennessy
Publisher : John Wiley & Sons
Page : 1220 pages
File Size : 43,6 Mb
Release : 2019-12-16
Category : Medical
ISBN : 9781119413417

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Pharmacoepidemiology by Brian L. Strom,Stephen E. Kimmel,Sean Hennessy Pdf

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.

Author : John Talbot,Jeffrey K. Aronson
Publisher : John Wiley & Sons
Page : 751 pages
File Size : 44,9 Mb
Release : 2011-10-28
Category : Medical
ISBN : 9781119952107

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Stephens' Detection and Evaluation of Adverse Drug Reactions by John Talbot,Jeffrey K. Aronson Pdf

The detection and evaluation of adverse drug reactions is crucial for understanding the safety of medicines and for preventing harm in patients. Not only is it necessary to detect new adverse drug reactions, but the principles and practice of pharmacovigilance apply to the surveillance of a wide range of medicinal products. Stephens' Detection and Evaluation of Adverse Drug Reactions provides a comprehensive review of all aspects of adverse drug reactions throughout the life cycle of a medicine, from toxicology and clinical trials through to pharmacovigilance, risk management, and legal and regulatory requirements. It also covers the safety of biotherapeutics and vaccines and includes new chapters on pharmacogenetics, proactive risk management, societal considerations, and the safety of drugs used in oncology and herbal medicines. This sixth edition of the classic text on drug safety is an authoritative reference text for all those who work in pharmacovigilance or have an interest in adverse drug reactions, whether in regulatory authorities, pharmaceutical companies, or academia. Praise for previous editions "This book presents a comprehensive and wide-ranging overview of the science of pharmacovigilance. For those entering or already experienced in the pharmaceutical sciences, this is an essential work.” - from a review in E-STREAMS "...a key text in the area of pharmacovigilance...extensively referenced and well-written...a valuable resource..." - from a review in The Pharmaceutical Journal

Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Assessment of the US Drug Safety System
Publisher : National Academies Press
Page : 346 pages
File Size : 41,7 Mb
Release : 2007-02-27
Category : Medical
ISBN : 9780309133944

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The Future of Drug Safety by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Assessment of the US Drug Safety System Pdf

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.

Author : Monique Elseviers,Björn Wettermark,Anna Birna Almarsdóttir,Morten Andersen,Ria Benko,Marion Bennie,Irene Eriksson,Brian Godman,Janet Krska,Elisabetta Poluzzi,Kstja Taxis,Vera Vlahovic-Palcevski,Robert Vander Stichele
Publisher : John Wiley & Sons
Page : 548 pages
File Size : 43,7 Mb
Release : 2016-05-31
Category : Medical
ISBN : 9781118949788

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Drug Utilization Research by Monique Elseviers,Björn Wettermark,Anna Birna Almarsdóttir,Morten Andersen,Ria Benko,Marion Bennie,Irene Eriksson,Brian Godman,Janet Krska,Elisabetta Poluzzi,Kstja Taxis,Vera Vlahovic-Palcevski,Robert Vander Stichele Pdf

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.

Author : Zbigniew Bańkowski,John F. Dunne
Publisher : World Health Organization
Page : 214 pages
File Size : 52,6 Mb
Release : 1994
Category : Drug monitoring
ISBN : UCAL:B4767456

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Drug Surveillance by Zbigniew Bańkowski,John F. Dunne Pdf

Records the proceedings of an international conference convened to consider mechanisms for improving international cooperation in the surveillance of drug safety and the reporting of adverse reactions. Attended by close to 200 representatives of regulatory authorities and the pharmaceutical industry as well as clinical pharmacologists, the conference aimed to identify the strengths and weaknesses of existing mechanisms for international cooperation and to propose improvements for the future.

Author : Thao Doan,Cheryl Renz,Fabio Lievano,Mondira Bhattacharya,Linda Scarazzini
Publisher : Elsevier Health Sciences
Page : 228 pages
File Size : 53,8 Mb
Release : 2018-07-31
Category : Medical
ISBN : 9780323581172

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Pharmacovigilance: A Practical Approach by Thao Doan,Cheryl Renz,Fabio Lievano,Mondira Bhattacharya,Linda Scarazzini Pdf

Written by experts in the field of pharmacovigilance and patient safety, this concise resource provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. Drs. Thao Doan, Fabio Lievano, Mondira Bhattacharya, and Linda Scarazzini provide essential information for health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance.

Author : Mohamed Izham Mohamed Ibrahim,Albert Wertheimer,Zaheer-Ud-Din Babar
Publisher : Academic Press
Page : 484 pages
File Size : 45,6 Mb
Release : 2017-10-31
Category : Medical
ISBN : 9780128112298

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Social and Administrative Aspects of Pharmacy in Low- and Middle-Income Countries by Mohamed Izham Mohamed Ibrahim,Albert Wertheimer,Zaheer-Ud-Din Babar Pdf

Social and Administrative Aspects of Pharmacy in Low- and Middle-Income Countries: Present Challenges and Future Solutions examines the particularities of low- and middle-income countries and offers solutions based on their needs, culture and available resources. Drawing from the firsthand experience of researchers and practitioners working in these countries, this book addresses the socio-behavioral aspects of pharmacy and health, pharmacoeconomics, pharmaceutical policy, supply management and marketing, pharmacoepidemiology and public health pharmacy specific to low- and middle-income countries. While some practices may be applied appropriately in disparate places, too often pharmacy practice in low- and middle-income countries is directly copied from successes in developed countries, despite the unique needs and challenges low- and middle-income countries face. Examines key issues and challenges of pharmacy practice and the pharmaceutical sector specific to low- and middle-income countries Compares pharmacy practice in developed and developing countries to highlight the unique challenges and opportunities of each Provides a blueprint for the future of pharmacy in low- and middle-income countries, including patient-centered care, evidence-based care and promoting the role of the pharmacist for primary health care in these settings