Drug Safety Data How To Analyze Summarize And Interpret To Determine Risk

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Drug Safety Data

Author : Michael J. Klepper
Publisher : Jones & Bartlett Learning
ISBN 13 : 9780763769123
Total Pages : 312 pages
Book Rating : 4.7/5 (691 download)

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Book Synopsis Drug Safety Data by : Michael J. Klepper

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)

Drug Safety Data

Author : Michael J. Klepper
Publisher :
ISBN 13 :
Total Pages : 312 pages
Book Rating : 4.:/5 (133 download)

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Book Synopsis Drug Safety Data by : Michael J. Klepper

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:

Quantitative Drug Safety and Benefit Risk Evaluation

Author : William Wang
Publisher : CRC Press
ISBN 13 : 0429949995
Total Pages : 347 pages
Book Rating : 4.4/5 (299 download)

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Book Synopsis Quantitative Drug Safety and Benefit Risk Evaluation by : William Wang

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.

Quantitative Evaluation of Safety in Drug Development

Author : Qi Jiang
Publisher : CRC Press
ISBN 13 : 1466555475
Total Pages : 382 pages
Book Rating : 4.4/5 (665 download)

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Book Synopsis Quantitative Evaluation of Safety in Drug Development by : Qi Jiang

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 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: State-of-the-Art Methods for Drug Safety Assessment Responding 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 development. It presents the latest statistical methods for drug safety assessment. The book’s three sections focus on study design, safety monitoring, and data evaluation/analysis. The book addresses key challenges across regulatory agencies, industry, and academia. It discusses quantitative approaches to safety evaluation and risk management in drug development, covering Bayesian methods, effective safety graphics, and risk-benefit evaluation. Written by a team of experienced leaders, this book brings the most advanced knowledge and statistical methods of drug safety to the statistical, clinical, and safety community. It shares best practices and stimulates further research and methodology development in the drug safety area.

Practical Drug Safety from A to Z

Author : Barton Cobert
Publisher : Jones & Bartlett Publishers
ISBN 13 : 0763745278
Total Pages : 406 pages
Book Rating : 4.7/5 (637 download)

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Book Synopsis Practical Drug Safety from A to Z by : Barton Cobert

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.

Statistical Methods for Drug Safety

Author : Robert D. Gibbons
Publisher : CRC Press
ISBN 13 : 1466561858
Total Pages : 297 pages
Book Rating : 4.4/5 (665 download)

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Book Synopsis Statistical Methods for Drug Safety by : Robert D. Gibbons

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

Analysis of Safety Data of Drug Trials

Author : Ton J. Cleophas
Publisher : Springer
ISBN 13 : 3030058042
Total Pages : 217 pages
Book Rating : 4.0/5 (3 download)

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Book Synopsis Analysis of Safety Data of Drug Trials by : Ton J. Cleophas

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.

Drug Safety Assessment in Clinical Trials

Author : Gene Sogliero-Gilbert
Publisher : CRC Press
ISBN 13 : 9780824788933
Total Pages : 456 pages
Book Rating : 4.7/5 (889 download)

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Book Synopsis Drug Safety Assessment in Clinical Trials by : Gene Sogliero-Gilbert

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.

Drug Safety

Author : Nigel S. B. Rawson
Publisher : FriesenPress
ISBN 13 : 146029100X
Total Pages : 274 pages
Book Rating : 4.4/5 (62 download)

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Book Synopsis Drug Safety by : Nigel S. B. Rawson

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.

The Future of Drug Safety

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309103045
Total Pages : 347 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Future of Drug Safety by : Institute of Medicine

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 2007-03-27 with total page 347 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.

Use of secondary population-based databases to evaluate the safety of medications

Author : Patricia Tennis
Publisher : RTI Press
ISBN 13 :
Total Pages : 32 pages
Book Rating : 4./5 ( download)

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Book Synopsis Use of secondary population-based databases to evaluate the safety of medications by : Patricia Tennis

Download or read book Use of secondary population-based databases to evaluate the safety of medications written by Patricia Tennis and published by RTI Press. This book was released on 2008-09-30 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt: Public concern is increasing over the safety of medicines, particularly serious adverse events detected after extensive use of products in the general marketplace. This concern has led to the need for prompt evaluation of safety signals within large populations following drug approval. The most relevant and available data resources primarily include electronic health care claims and electronic medical records and can be used to identify new safety issues and to evaluate known or suspected signals. In this review paper, we (1) summarize the data resources available for detection and evaluation of safety signals and (2) critically describe these resources and methods used in drug safety research. For each type of data resource, we summarize the characteristics and describe the associated applications and appropriate methods. To place each data resource and method in perspective, we provide examples from disease areas with substantial public health impact. We conclude that in certain circumstances these data resources can be valuable for the relatively cost-effective evaluation of serious adverse events in users of specific medications. However, implementation of such research requires a thorough understanding of the strengths and weaknesses of the data sources and the pharmacoepidemiologic methods used for analysis.

Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation

Author : William Wang
Publisher : CRC Press
ISBN 13 : 9780429488801
Total Pages : 382 pages
Book Rating : 4.4/5 (888 download)

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Book Synopsis Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation by : William Wang

Download or read book Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation written by William Wang and published by CRC Press. This book was released on 2021-12-31 with total page 382 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"--

FDA Lacks Comprehensive Data to Determine Whether Risk Evaluation and Mitigation Strategies Improve Drug Safety.

Author : CreateSpace Independent Publishing Platform
Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781722230739
Total Pages : 38 pages
Book Rating : 4.2/5 (37 download)

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Book Synopsis FDA Lacks Comprehensive Data to Determine Whether Risk Evaluation and Mitigation Strategies Improve Drug Safety. by : CreateSpace Independent Publishing Platform

Download or read book FDA Lacks Comprehensive Data to Determine Whether Risk Evaluation and Mitigation Strategies Improve Drug Safety. written by CreateSpace Independent Publishing Platform and published by Createspace Independent Publishing Platform. This book was released on 2018-07-05 with total page 38 pages. Available in PDF, EPUB and Kindle. Book excerpt: FDA lacks comprehensive data to determine whether risk evaluation and mitigation strategies improve drug safety.

The Perception and Management of Drug Safety Risks

Author : Bruno Horisberger
Publisher : Springer
ISBN 13 :
Total Pages : 248 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Perception and Management of Drug Safety Risks by : Bruno Horisberger

Download or read book The Perception and Management of Drug Safety Risks written by Bruno Horisberger and published by Springer. This book was released on 1989-01-16 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book represents a collaborative effort by academic experts, members of the pharmaceutical industry, international organizations, and public spokesmen to explore the problems associated with drug risk and drug safety. In an international conference, representatives from 10 countries discussed pharmacology, epidemiology, risk evaluation, regulatory standards, and public communication. Specific topics dealt with include the risk/benefit relationship, biostatistical data interpretation, consumer perception, and proposals for multidisciplinary and international efforts to address challenges in drug safety management.

Risk Assessment and Risk Management in the Pharmaceutical Industry

Author : James L. Vesper
Publisher :
ISBN 13 :
Total Pages : 304 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Risk Assessment and Risk Management in the Pharmaceutical Industry by : James L. Vesper

Download or read book Risk Assessment and Risk Management in the Pharmaceutical Industry written by James L. Vesper and published by . This book was released on 2006 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt:

FDA Lacks Comprehensive Data to Determine Whether Risk Evaluation and Mitigation Strategies Improve Drug Safety

Author : United States. Department of Health and Human Services. Office of Inspector General
Publisher :
ISBN 13 :
Total Pages : 34 pages
Book Rating : 4.:/5 (951 download)

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Book Synopsis FDA Lacks Comprehensive Data to Determine Whether Risk Evaluation and Mitigation Strategies Improve Drug Safety by : United States. Department of Health and Human Services. Office of Inspector General

Download or read book FDA Lacks Comprehensive Data to Determine Whether Risk Evaluation and Mitigation Strategies Improve Drug Safety written by United States. Department of Health and Human Services. Office of Inspector General and published by . This book was released on 2013 with total page 34 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Cobert's Manual of Drug Safety and Pharmacovigilance

Author : Barton Cobert
Publisher :
ISBN 13 : 9789811215230
Total Pages : 524 pages
Book Rating : 4.2/5 (152 download)

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Book Synopsis Cobert's Manual of Drug Safety and Pharmacovigilance by : Barton Cobert

Download or read book Cobert's Manual of Drug Safety and Pharmacovigilance written by Barton Cobert and published by . 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.