Download or read book Statistical Methods for Knowledge Discovery in Adverse Drug Reaction Surveillance written by G. Niklas Norén and published by . This book was released on 2007 with total page 41 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Practical Aspects of Signal Detection in Pharmacovigilance written by Council for International Organizations of Medical Sciences (CIOMS) and published by Cioms. This book was released on 2010 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Ralph Edwards RARE EVENTS written by Ian Hembrow and published by Springer Nature. This book was released on 2023-01-20 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical treatments designed to help people can also be harmful or fatal. Around 2.5 million people die this way each year. So if any kind of medicine makes someone unwell, they or their doctor should report it. Those reports, from nearly every country in the world, go to the Uppsala Monitoring Centre (UMC) in Sweden. As the Centre’s first director, Professor Ivor Ralph Edwards transformed it from a tiny operation with limited horizons into an internationally acclaimed scientific organization at the heart of the World Health Organization’s Programme for International Drug Monitoring. He was then succeeded by his wife, Dr Marie Lindquist. This is the story of how a new science developed and a passionate and dedicated pursuit of worldwide medicines safety, with an unerring focus on the welfare of patients. The pioneering work of Ralph, Marie and their collaborators on every continent protected the lives of millions of people. It may yet improve the lives of billions more.
Download or read book Encyclopedia of Biopharmaceutical Statistics Four Volume Set written by Shein-Chung Chow and published by CRC Press. This book was released on 2018-09-03 with total page 2434 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences. Features of the Fourth Edition: 1. 78 new and revised entries have been added for a total of 308 chapters and a fourth volume has been added to encompass the increased number of chapters. 2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies. 3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and analysis of biosimilar drug development, big data analytics, and real world evidence for clinical research and development. 4. A table of contents organized by stages of biopharmaceutical development provides easy access to relevant topics. About the Editor: Shein-Chung Chow, Ph.D. is currently an Associate Director, Office of Biostatistics, U.S. Food and Drug Administration (FDA). Dr. Chow is an Adjunct Professor at Duke University School of Medicine, as well as Adjunct Professor at Duke-NUS, Singapore and North Carolina State University. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Chapman & Hall/CRC Biostatistics Book Series and the author of 28 books and over 300 methodology papers. He was elected Fellow of the American Statistical Association in 1995.
Download or read book Translational Biomedical Informatics written by Bairong Shen and published by Springer. This book was released on 2016-10-31 with total page 331 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book introduces readers to essential methods and applications in translational biomedical informatics, which include biomedical big data, cloud computing and algorithms for understanding omics data, imaging data, electronic health records and public health data. The storage, retrieval, mining and knowledge discovery of biomedical big data will be among the key challenges for future translational research. The paradigm for precision medicine and healthcare needs to integratively analyze not only the data at the same level – e.g. different omics data at the molecular level – but also data from different levels – the molecular, cellular, tissue, clinical and public health level. This book discusses the following major aspects: the structure of cross-level data; clinical patient information and its shareability; and standardization and privacy. It offers a valuable guide for all biologists, biomedical informaticians and clinicians with an interest in Precision Medicine Informatics.
Download or read book Data Mining Applications in Engineering and Medicine written by Adem Karahoca and published by BoD – Books on Demand. This book was released on 2012-08-29 with total page 340 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data Mining Applications in Engineering and Medicine targets to help data miners who wish to apply different data mining techniques. Data mining generally covers areas of statistics, machine learning, data management and databases, pattern recognition, artificial intelligence, etc. In this book, most of the areas are covered by describing different applications. This is why you will find here why and how Data Mining can also be applied to the improvement of project management. Since Data Mining has been widely used in a medical field, this book contains different chapters reffering to some aspects and importance of its use in the mentioned field: Incorporating Domain Knowledge into Medical Image Mining, Data Mining Techniques in Pharmacovigilance, Electronic Documentation of Clinical Pharmacy Interventions in Hospitals etc. We hope that this book will inspire readers to pursue education and research in this emerging field.
Download or read book Statistical Methods for Evaluating Safety in Medical Product Development written by A. Lawrence Gould and published by John Wiley & Sons. This book was released on 2014-12-08 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book gives professionals in clinical research valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It also provides understanding and practical guidance on the application of contemporary statistical methods to contemporary issues in safety evaluation during medical product development. Each chapter provides sufficient detail to the reader to undertake the design and analysis of experiments at various stages of product development, including comprehensive references to the relevant literature. Provides a guide to statistical methods and application in medical product development Assists readers in undertaking design and analysis of experiments at various stages of product development Features case studies throughout the book, as well as, SAS and R code
Download or read book Advances in Statistical Methods for the Health Sciences written by Jean-Louis Auget and published by Springer Science & Business Media. This book was released on 2007-08-08 with total page 561 pages. Available in PDF, EPUB and Kindle. Book excerpt: Statistical methods have become an increasingly important and integral part of research in the health sciences. Many sophisticated methodologies have been developed for specific applications and problems. This self-contained comprehensive volume covers a wide range of topics pertaining to new statistical methods in the health sciences, including epidemiology, pharmacovigilance, quality of life, survival analysis, and genomics. The book will serve the health science community as well as practitioners, researchers, and graduate students in applied probability, statistics, and biostatistics.
Download or read book Clinical Trials Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2009-06-17 with total page 1247 pages. Available in PDF, EPUB and Kindle. Book excerpt: Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.
Download or read book Pharmacoepidemiology written by Stanley Edlavitch and published by Routledge. This book was released on 2018-12-19 with total page 379 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume is comprised of papers presented at the Third International Conference on Pharmacoepidemiology, held September 9-11, 1987, in Minneapolis, Minnesota. The book is divided into four sections, which reflect the four themes of the conference: Social Impact of Pharmacoepidemiology; Drug Epidemiology and the Law; Drug Surveillance; and Drugs, Populations, and Outcomes: Specific Studies. The collection of papers discusses the social and legal impact of epidemiology, the system of checks and balances that is necessary for the field, the importance of core support for researchers, and the goal of an enlightened and informed public, including the media, consumer advocates, and the courts. Contributing authors offer perspectives from academia, practice, government, industry and the law. Numerous tables and figures are included to illustrate many of the papers within the text. This book offers substantial reading for epidemiologists and individuals interested in the field of pharmacoepidemiology.
Download or read book Interactive Knowledge Discovery and Data Mining in Biomedical Informatics written by Andreas Holzinger and published by Springer. This book was released on 2014-06-17 with total page 373 pages. Available in PDF, EPUB and Kindle. Book excerpt: One of the grand challenges in our digital world are the large, complex and often weakly structured data sets, and massive amounts of unstructured information. This “big data” challenge is most evident in biomedical informatics: the trend towards precision medicine has resulted in an explosion in the amount of generated biomedical data sets. Despite the fact that human experts are very good at pattern recognition in dimensions of = 3; most of the data is high-dimensional, which makes manual analysis often impossible and neither the medical doctor nor the biomedical researcher can memorize all these facts. A synergistic combination of methodologies and approaches of two fields offer ideal conditions towards unraveling these problems: Human–Computer Interaction (HCI) and Knowledge Discovery/Data Mining (KDD), with the goal of supporting human capabilities with machine learning./ppThis state-of-the-art survey is an output of the HCI-KDD expert network and features 19 carefully selected and reviewed papers related to seven hot and promising research areas: Area 1: Data Integration, Data Pre-processing and Data Mapping; Area 2: Data Mining Algorithms; Area 3: Graph-based Data Mining; Area 4: Entropy-Based Data Mining; Area 5: Topological Data Mining; Area 6 Data Visualization and Area 7: Privacy, Data Protection, Safety and Security.
Download or read book Mann s Pharmacovigilance written by Elizabeth B. Andrews and published by John Wiley & Sons. This book was released on 2014-06-23 with total page 878 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Spatial and Syndromic Surveillance for Public Health written by Andrew B. Lawson and published by John Wiley & Sons. This book was released on 2005-05-13 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: Following the events of 9/11 and in the current world climate, there is increasing concern of the impact of potential bioterrorism attacks. Spatial surveillance systems are used to detect changes in public health data, and alert us to possible outbreaks of disease, either from natural resources or from bioterrorism attacks. Statistical methods play a key role in spatial surveillance, as they are used to identify changes in data, and build models of that data in order to make predictions about future activity. This book is the first to provide an overview of all the current key methods in spatial surveillance, and present them in an accessible form, suitable for the public health professional. It features an abundance of examples using real data, highlighting the practical application of the methodology. It is edited and authored by leading researchers and practitioners in spatial surveillance methods. Provides an overview of the current key methods in spatial surveillance of public health data. Includes coverage of both single and multiple disease surveillance. Covers all of the key topics, including syndromic surveillance, spatial cluster detection, and Bayesian data mining.
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 Statistical Methods for Drug Safety written by Robert D. Gibbons and published by CRC Press. This book was released on 2015-07-28 with total page 297 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explore Important Tools for High-Quality Work in Pharmaceutical SafetyStatistical Methods for Drug Safety presents a wide variety of statistical approaches for analyzing pharmacoepidemiologic data. It covers both commonly used techniques, such as proportional reporting ratios for the analysis of spontaneous adverse event reports, and newer approach
Download or read book Statistical Learning and Data Sciences written by Alexander Gammerman and published by Springer. This book was released on 2015-04-02 with total page 449 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the refereed proceedings of the Third International Symposium on Statistical Learning and Data Sciences, SLDS 2015, held in Egham, Surrey, UK, April 2015. The 36 revised full papers presented together with 2 invited papers were carefully reviewed and selected from 59 submissions. The papers are organized in topical sections on statistical learning and its applications, conformal prediction and its applications, new frontiers in data analysis for nuclear fusion, and geometric data analysis.
Download or read book Advances in Information Retrieval written by Pavel Serdyukov and published by Springer. This book was released on 2013-03-12 with total page 919 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the proceedings of the 35th European Conference on IR Research, ECIR 2013, held in Moscow, Russia, in March 2013. The 55 full papers, 38 poster papers and 10 demonstrations presented in this volume were carefully reviewed and selected from 287 submissions. The papers are organized in the following topical sections: user aspects; multimedia and cross-media IR; data mining; IR theory and formal models; IR system architectures; classification; Web; event detection; temporal IR, and microblog search. Also included are 4 tutorial and 2 workshop presentations.
