Drug Safety Data

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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: How to Analyze, Summarize and Interpret to Determine Risk

Author : Michael J. Klepper
Publisher : Jones & Bartlett Publishers
ISBN 13 : 1449671551
Total Pages : 316 pages
Book Rating : 4.4/5 (496 download)

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Book Synopsis Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk by : Michael J. Klepper

Download or read book Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk written by Michael J. Klepper and published by Jones & Bartlett Publishers. This book was released on 2010-10-25 with total page 316 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 Evaluation

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
ISBN 13 : 1119097401
Total Pages : 918 pages
Book Rating : 4.1/5 (19 download)

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Book Synopsis Drug Safety Evaluation by : Shayne Cox Gad

Download or read book Drug Safety Evaluation written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2016-11-18 with total page 918 pages. Available in PDF, EPUB and Kindle. Book excerpt: This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition

Drug Safety in Developing Countries

Author : Yaser Mohammed Al-Worafi
Publisher : Academic Press
ISBN 13 : 0128204125
Total Pages : 656 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Drug Safety in Developing Countries by : Yaser Mohammed Al-Worafi

Download or read book Drug Safety in Developing Countries written by Yaser Mohammed Al-Worafi and published by Academic Press. This book was released on 2020-06-03 with total page 656 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Quantitative Evaluation of Safety in Drug Development

Author : Qi Jiang
Publisher : CRC Press
ISBN 13 : 9780367576004
Total Pages : 382 pages
Book Rating : 4.5/5 (76 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 2020-06-30 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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. Features, Focuses on the quantitative evaluation of safety of biopharmaceutical products, Covers several Bayesian approaches, including a meta-experimental design for evaluating cardiovascular risk, adaptive trials for drug safety, and network meta-analysis for safety evaluation, Explains why a DMC safety report differs from a safety report written at the end of the trial, Describes the safety surveillance and signal detection process, Discusses the observational medical outcomes partnership (OMOP), Addresses regulatory issues in the meta-analysis of safety data, Presents safety evaluation and quantitative approaches during preclinical and early phases of drug development, 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. Book jacket.

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.

Registries for Evaluating Patient Outcomes

Author : Agency for Healthcare Research and Quality/AHRQ
Publisher : Government Printing Office
ISBN 13 : 1587634333
Total Pages : 396 pages
Book Rating : 4.5/5 (876 download)

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Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ

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.

Cobert's Manual of Drug Safety and Pharmacovigilance

Author : Barton Cobert
Publisher : Jones & Bartlett Publishers
ISBN 13 : 0763791601
Total Pages : 431 pages
Book Rating : 4.7/5 (637 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 Jones & Bartlett Publishers. This book was released on 2011-04 with total page 431 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely revised and updated, the Manual of Drug Safety and Pharmacovigilance, Second Edition is a how-to manual for those working in the fields of drug safety, clinical research, pharmacuetucal, regulatory affairs, government and legal professions. This comprehensive and practical guide discusses the theory and the practicalities of drug safety (also known as pharmacovigilance) and side effects, as well as providing essential information on drug safety and regulations, including: recognizing, monitoring, reporting, and cataloging serious adverse drug reactions. The Manual of Drug Safety and Pharmacovigilance, Second Edition teaches the ins and outs of drug safety in the industry, hospitals, FDA, and other health agencies both in the US and around the world, and presents critical information about what is done when confronted with a drug safety problem.

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:

Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition)

Author : Cobert Barton
Publisher : World Scientific
ISBN 13 : 9813279168
Total Pages : 524 pages
Book Rating : 4.8/5 (132 download)

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Book Synopsis Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) by : Cobert Barton

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.

Safe and Effective Medicines for Children

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309225493
Total Pages : 432 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Safe and Effective Medicines for Children by : Institute of Medicine

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.

The Future of Drug Safety

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309133947
Total Pages : 346 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 2007-02-27 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.

Pharmacoepidemiology

Author : Brian L. Strom
Publisher : John Wiley & Sons
ISBN 13 : 1119413419
Total Pages : 1220 pages
Book Rating : 4.1/5 (194 download)

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Book Synopsis Pharmacoepidemiology by : Brian L. Strom

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.

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.

Ethical and Scientific Issues in Studying the Safety of Approved Drugs

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309218160
Total Pages : 292 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Ethical and Scientific Issues in Studying the Safety of Approved Drugs by : Institute of Medicine

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.

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.

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.