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Reducing The Harm Of Medication Recent Trends In Pharmacovigilance Volume Ii Book in PDF, ePub and Kindle version is available to download in english. Read online anytime anywhere directly from your device. Click on the download button below to get a free pdf file of Reducing The Harm Of Medication Recent Trends In Pharmacovigilance Volume Ii book. This book definitely worth reading, it is an incredibly well-written.
Author : Elena Ramírez,Francisco J. De Abajo,Miguel Gonzalez-Muñoz,Chanda Kulkarni
Publisher : Frontiers Media SA
Page : 132 pages
File Size : 49,5 Mb
Release : 2023-05-02
Category : Medical
ISBN : 9782832522240
Author : Elena Ramírez,Francisco J. De Abajo,Miguel Gonzalez-Muñoz,Chanda Kulkarni
Publisher : Frontiers Media SA
Page : 165 pages
File Size : 46,9 Mb
Release : 2022-10-07
Category : Science
ISBN : 9782832501917
Author : World Health Organization,Council for International Organizations of Medical Sciences,Cioms
Publisher : Unknown
Page : 381 pages
File Size : 52,7 Mb
Release : 2001-01-01
Category : Medical
ISBN : 9290360747
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.
Author : Yaser Mohammed Al-Worafi
Publisher : Academic Press
Page : 656 pages
File Size : 47,7 Mb
Release : 2020-06-03
Category : Business & Economics
ISBN : 9780128204122
Drug Safety in Developing Countries: Achievements and Challenges provides comprehensive information on drug safety issues in developing countries. Drug safety practice in developing countries varies substantially from country to country. This can lead to a rise in adverse reactions and a lack of reporting can exasperate the situation and lead to negative medical outcomes. This book documents the history and development of drug safety systems, pharmacovigilance centers and activities in developing countries, describing their current situation and achievements of drug safety practice. Further, using extensive case studies, the book addresses the challenges of drug safety in developing countries. Provides a single resource for educators, professionals, researchers, policymakers, organizations and other readers with comprehensive information and a guide on drug safety related issues Describes current achievements of drug safety practice in developing countries Addresses the challenges of drug safety in developing countries Provides recommendations, including practical ways to implement strategies and overcome challenges surrounding drug safety
Author : Kerm Henriksen
Publisher : Unknown
Page : 526 pages
File Size : 54,9 Mb
Release : 2005
Category : Medical
ISBN : CHI:70548902
v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.
Author : Victor R. Preedy
Publisher : Academic Press
Page : 1106 pages
File Size : 49,9 Mb
Release : 2016-04-25
Category : Science
ISBN : 9780128006771
Neuropathology of Drug Addictions and Substance Misuse, Volume 3: General Processes and Mechanisms, Prescription Medications, Caffeine and Areca, Polydrug Misuse, Emerging Addictions and Non-Drug Addictions is the third of three volumes in this informative series and offers a comprehensive examination of the adverse consequences of the most common drugs of abuse. Each volume serves to update the reader’s knowledge on the broader field of addiction as well as to deepen understanding of specific addictive substances. Volume 3 addresses prescription medications, caffeine, polydrug misuse, and non-drug addictions. Each section provides data on the general, molecular, cellular, structural, and functional neurological aspects of a given substance, with a focus on the adverse consequences of addictions. Research shows that the neuropathological features of one addiction are often applicable to those of others, and understanding these commonalties provides a platform for studying specific addictions in more depth and may ultimately lead researchers toward new modes of understanding, causation, prevention and treatment. However, marshalling data on the complex relationships between addictions is difficult due to the myriad of material and substances. Offers a modern approach to understanding the pathology of substances of abuse, offering an evidence-based ethos for understanding the neurology of addictions Fills an existing gap in the literature by serving as a “one-stop-shopping synopsis of everything to do with the neuropathology of drugs of addiction and substance misuse Includes in each chapter: list of abbreviations, abstract, introduction, applications to other addictions and substance misuse, mini-dictionary of terms, summary points, 6+ figures and tables, full references Offers coverage of preclinical, clinical, and population studies, from the cell to whole organs, and from the genome to whole body
Author : Filippo Drago,Rafael Maldonado
Publisher : Frontiers Media SA
Page : 588 pages
File Size : 46,8 Mb
Release : 2021-10-14
Category : Science
ISBN : 9782889714858
Author : Mireia Solerdelcoll,Mohammadreza Shalbafan,Renato de Filippis
Publisher : Frontiers Media SA
Page : 97 pages
File Size : 41,8 Mb
Release : 2023-12-27
Category : Medical
ISBN : 9782832541791
Author : Council for International Organizations of Medical Sciences (CIOMS)
Publisher : Cioms
Page : 0 pages
File Size : 49,7 Mb
Release : 2010
Category : Drug monitoring
ISBN : 9290360828
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 : World Health Organization
Publisher : Unknown
Page : 0 pages
File Size : 50,9 Mb
Release : 2014
Category : Drugs
ISBN : 9290360844
Risk management of medicines is a wide and rapidly evolving concept and practice, following a medicine throughout its lifecycle, from first administration in humans through clinical studies and then marketing in the patient population at large. Previous reports from CIOMS I - VIII provided practical guidance in some essential components of risk management such as terminology and reporting of adverse drug reactions, management of safety information from clinical trials, and safety signal detection. Beyond the detection, identification, and characterization of risk, "risk minimization" is used as an umbrella term for the prevention or mitigation of an undesirable outcome. Risk management always includes tools for "routine risk minimization" such as product information, the format depending on the jurisdiction, to inform the patient and the prescriber, all of which serve to prevent or mitigate adverse effects. Until this current CIOMS IX document, limited guidance has been available on how to determine which risks need "additional risk minimization," select the appropriate tools, apply and implement such tools globally and locally, and measure if they are effective and valuable. Included in the report is a CIOMS framework for the evaluation of effectiveness of risk minimization, a discussion of future trends and developments, an annex specifically addressing vaccines, and examples from real life.
Author : Mansour Adam Mahmoud,Brian Godman,Ahmed Awaisu,Ahmed Ibrahim Fathelrahman,Hisham Aljadhey,Joseph O. Fadare,Johanna Catharina Meyer,Fahad Saleem
Publisher : Frontiers Media SA
Page : 217 pages
File Size : 42,8 Mb
Release : 2023-02-07
Category : Science
ISBN : 9782832513910
Author : Agency for Healthcare Research and Quality/AHRQ
Publisher : Government Printing Office
Page : 396 pages
File Size : 49,9 Mb
Release : 2014-04-01
Category : Medical
ISBN : 9781587634338
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.
Author : World Health Organization
Publisher : Unknown
Page : 18 pages
File Size : 51,9 Mb
Release : 2004-01-01
Category : Drug monitoring
ISBN : 9241592214
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.
Author : Adam Bohr,Kaveh Memarzadeh
Publisher : Academic Press
Page : 385 pages
File Size : 51,7 Mb
Release : 2020-06-21
Category : Computers
ISBN : 9780128184394
Artificial Intelligence (AI) in Healthcare is more than a comprehensive introduction to artificial intelligence as a tool in the generation and analysis of healthcare data. The book is split into two sections where the first section describes the current healthcare challenges and the rise of AI in this arena. The ten following chapters are written by specialists in each area, covering the whole healthcare ecosystem. First, the AI applications in drug design and drug development are presented followed by its applications in the field of cancer diagnostics, treatment and medical imaging. Subsequently, the application of AI in medical devices and surgery are covered as well as remote patient monitoring. Finally, the book dives into the topics of security, privacy, information sharing, health insurances and legal aspects of AI in healthcare. Highlights different data techniques in healthcare data analysis, including machine learning and data mining Illustrates different applications and challenges across the design, implementation and management of intelligent systems and healthcare data networks Includes applications and case studies across all areas of AI in healthcare data
Author : Institute of Medicine,Committee on Technological Innovation in Medicine
Publisher : National Academies Press
Page : 241 pages
File Size : 55,8 Mb
Release : 1990-02-01
Category : Medical
ISBN : 9780309042864
The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.