Download or read book Drug Safety Data written by Michael J. Klepper and published by Jones & Bartlett Learning. This book was released on 2010-10-25 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk was selected for The First Clinical Research Bookshelf - Essential reading for clinical research professionals by the Journal of Clinical Research Best Practices. Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides drug safety/pharmacovogilance professionals, pharmaceutical and clinical research scientists, statisticians, programmers, medical writers, and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data. The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an invaluable reference for pre- and post-marketing risk assessment. With decades of pharmaceutical research and drug safety expertise, authors Dr. Klepper and Dr. Cobert discuss how quality planning, safety training, and data standardization result in significant cost, time, and resource savings. Through illustrative, step-by-step instruction, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is the definitive guide to drug safety data analysis and reporting. Key features include: * Step-by-step instruction on how to analyze, summarize and interpret safety data for mandatory governmental safety reports * Pragmatic tips...and mistakes to avoid * Simple explanations of what safety data are collected, and what the data mean * Practical approaches to determining a drug effect and understanding its clinical significance * Guidance for determining risk throughout the lifecycle of a drug, biologic or nutraceutical * Examples of user-friendly data displays that enhance safety signal identification * Ways to improve data quality and reduce the time, resources and costs involved in mandatory safety reporting * Relevant material for the required training of drug safety/pharmacovigilance professionals * SPECIAL FEATURE: Actual examples of an Integrated Analysis of Safety (IAS) -used in the preparation of the Integrated Summary of Safety (ISS) and the Summary of Clinical Safety (SCS) reports -, and the Periodic Safety Update Report (PSUR)

Download or read book Drug Safety Data written by Michael J. Klepper and published by . This book was released on 2011 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Quantitative Drug Safety and Benefit Risk Evaluation written by William Wang and published by CRC Press. This book was released on 2021-12-30 with total page 347 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation provides a comprehensive coverage on safety monitoring methodologies, covering both global trends and regional initiatives. Pharmacovigilance has traditionally focused on the handling of individual adverse event reports however recently there had been a shift towards aggregate analysis to better understand the scope of product risks. Written to be accessible not only to statisticians but also to safety scientists with a quantitative interest, this book aims to bridge the gap in knowledge between medical and statistical fields creating a truly multi-disciplinary approach that is very much needed for 21st century safety evaluation.

Download or read book Quantitative Evaluation of Safety in Drug Development written by Qi Jiang and published by CRC Press. This book was released on 2014-12-08 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: State-of-the-Art Methods for Drug Safety AssessmentResponding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product deve

Download or read book Practical Drug Safety from A to Z written by Barton Cobert and published by Jones & Bartlett Publishers. This book was released on 2009-10-06 with total page 406 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Practical Drug Safety from A to Z is an alphabetical guide to drug safety monitoring (pharmacovigilance), covering literally, the "A to Z" of maintaining drug safety. Written by experts in the field, this book is a perfect to companion to the Manual of Drug Safety and Pharmacovigilance and an essential reference for pharmacists, pharmacologists, hospital administrators, medical liability lawyers, and others.

Download or read book Evidence Synthesis and Meta analysis for Drug Safety written by Council for International Organizations of Medical Sciences (CIOMS) and published by World Health Organization. This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: At any point in the drug development process, systematic reviews and meta-analysis can provide important information to guide the future path of the development program and any actions that might be needed in the post-marketing setting. This report gives the rationale for why and when a meta-analysis should be considered, all in the context of regulatory decision-making, and the tasks, data collection, and analyses that need to be carried out to inform those decisions. There is increasing demand by decision-makers in health care, the bio-pharmaceutical industry, and society at large to have access to the best available evidence on benefits and risks of medicinal products. The best strategy will take an overview of all the evidence and where it is possible and sensible, combine the evidence and summarize the results. For efficacy, the outcomes generally use the same or very similar predefined events for each of the trials to be included. Most regulatory guidance and many Cochrane Collaboration reviews have usually given more attention to assessment of benefits, while issues around combining evidence on harms have not been as well-covered. However, the (inevitably) unplanned nature of the data on safety makes the process more difficult. Combining evidence on adverse events (AEs), where these were not the focus of the original studies, is more challenging than combining evidence on pre-specified benefits. This focus on AEs represents the main contribution of the current CIOMS X report. The goal of the CIOMS X report is to provide principles on appropriate application of meta-analysis in assessing safety of pharmaceutical products to inform regulatory decision-making. This report is about meta-analysis in this narrow area, but the present report should also provide conceptually helpful points to consider for a wider range of applications, such as vaccines, medical devices, veterinary medicines or even products that are combinations of medicinal products and medical devices. Although some of the content of this report describes highly technical statistical concepts and methods (in particular Chapter 4), the ambition of the working group has been to make it comprehensible to non-statisticians for its use in clinical epidemiology and regulatory science. To that end, Chapters 3 and 4, which contain the main technical statistical aspects of the appropriate design, analysis and reporting of a meta-analysis of safety data are followed by Chapter 5 with a thought process for evaluating the findings of a meta-analysis and how to communicate these.

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 Communicating about Risks and Safe Use of Medicines written by Priya Bahri and published by Springer Nature. This book was released on 2020-06-17 with total page 523 pages. Available in PDF, EPUB and Kindle. Book excerpt: At the core of this book lies the question how to approach medicines, risks and communication as a researcher - or anybody planning and evaluating a communication intervention, or wanting to understand communication events in private and the media. With a view to tackle current shortcomings of communication systems and processes for improved implementation, patient satisfaction and health outcomes, a multilayered approach is presented. This combines multiple data types and methods to obtain a wider and deeper understanding of the major parties and their interactions, as well as the healthcare, social and political contexts of information flows, how they interfere and which impact they have. Illustrated with real life experiences of safety concerns with medicines, worldwide active experts discuss the methods and contributions their disciplines can offer. With considerations on terminologies, tabulated overviews on communication types and outcomes, a patient-centred vision and plain language for non-medical readers, the book creates a platform for multidisciplinary collaborations amongst researchers as well as practitioners from communications, healthcare, the social sciences and pharmacovigilance. Importantly, it advocates for an active role of patients and highlights the achievements and aspirations of patient organisations. Finally, the book suggests establishing an inclusive discipline of humanities and epidemiology of medicinal product risk communication to realise full research potential. The authors are driven by the curiosity for communication as the most human behaviour, and as good health is amongst the basic human needs, medicinal product risk communication is an exciting research field of high global relevance.

Download or read book Analysis of Safety Data of Drug Trials written by Ton J. Cleophas and published by Springer. This book was released on 2019-02-26 with total page 217 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 2010, the 5th edition of the textbook, "Statistics Applied to Clinical Studies", was published by Springer and since then has been widely distributed. The primary object of clinical trials of new drugs is to demonstrate efficacy rather than safety. However, a trial in humans which does not adequately address safety is unethical, while the assessment of safety variables is an important element of the trial. An effective approach is to present summaries of the prevalence of adverse effects and their 95% confidence intervals. In order to estimate the probability that the differences between treatment and control group occurred merely by chance, a statistical test can be performed. In the past few years, this pretty crude method has been supplemented and sometimes, replaced with more sophisticated and better sensitive methodologies, based on machine learning clusters and networks, and multivariate analyses. As a result, it is time that an updated version of safety data analysis was published. The issue of dependency also needs to be addressed. Adverse effects may be either dependent or independent of the main outcome. For example, an adverse effect of alpha blockers is dizziness and this occurs independently of the main outcome "alleviation of Raynaud 's phenomenon". In contrast, the adverse effect "increased calorie intake" occurs with "increased exercise", and this adverse effect is very dependent on the main outcome "weight loss". Random heterogeneities, outliers, confounders, interaction factors are common in clinical trials, and all of them can be considered as kinds of adverse effects of the dependent type. Random regressions and analyses of variance, high dimensional clusterings, partial correlations, structural equations models, Bayesian methods are helpful for their analysis. The current edition was written for non-mathematicians, particularly medical and health professionals and students. It provides examples of modern analytic methods so far largely unused in safety analysis. All of the 14 chapters have two core characteristics, First, they are intended for current usage, and they are particularly concerned with that usage. Second, they try and tell what readers need to know in order to understand and apply the methods. For that purpose, step by step analyses of both hypothesized and real data examples are provided.

Download or read book Safe and Effective Medicines for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2012-10-13 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.

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 The Future of Drug Safety written by Institute of Medicine and published by National Academies Press. This book was released on 2007-02-27 with total page 346 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Drug Safety Assessment in Clinical Trials written by Gene Sogliero-Gilbert and published by CRC Press. This book was released on 1993-07-14 with total page 456 pages. Available in PDF, EPUB and Kindle. Book excerpt: Details the methods pharmaceutical companies employ to determine the safety profile of their drugs. Statistical procedures currently used or developed to analyze, display and compare the massive amounts of laboratory data collected from controlled clinical trials are surveyed.

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 396 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 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.

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 Cobert s Manual Of Drug Safety And Pharmacovigilance Third Edition written by Cobert Barton and published by World Scientific. This book was released on 2019-04-10 with total page 524 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely revised and updated, Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, is a how-to manual for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, risk management, quality/compliance, and in government and legal professions.This comprehensive and practical guide discusses the theory and the practicalities of drug safety (also known as pharmacovigilance), and provides essential information on drug safety and regulations in the United States, Europe Union, and more, including: recognizing, monitoring, reporting, and cataloging serious adverse drug reactions.Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, teaches the daily practice of drug safety in industry, hospitals, the FDA and other health agencies — both in the United States and around the world — and provides critical information about what to do when confronted with a drug safety problem.