Monitoring for Drug Safety

Monitoring for Drug Safety

Author: William Howard Wallace Inman

Publisher:

ISBN: UOM:39015003225706

Category: Drug utilization

Page: 673

View: 589

Categories: Drug utilization

Cobert s Manual of Drug Safety and Pharmacovigilance

Cobert s Manual of Drug Safety and Pharmacovigilance

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, pharmacology, regulatory affairs, government and legal ...

Author: Barton Cobert

Publisher: Jones & Bartlett Publishers

ISBN: 9780763791599

Category: Medical

Page: 407

View: 211

Rev. ed. of: Manual of drug safety and pharmacovigilance / Barton L. Cobert. c2007.
Categories: Medical

Practical Drug Safety from A to Z

Practical Drug Safety from A to Z

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 ...

Author: Barton Cobert

Publisher: Jones & Bartlett Publishers

ISBN: 9780763745271

Category: Medical

Page: 402

View: 262

The Dictionary of Drug Safety and Pharmacovigilance is an alphabetical guide to drug safety monitoring (pharmacovigilance), covering literally, the
Categories: Medical

An Introduction to Pharmacovigilance

An Introduction to Pharmacovigilance

"This new edition of a clear and succinct yet comprehensive guide to the field provides exactly the right introduction for those new to the challenges and the excitement of pharmacovigilance.

Author: Patrick Waller

Publisher: John Wiley & Sons

ISBN: 9781119289784

Category: Medical

Page: 192

View: 165

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. This introductory guide is designed to aid the rapid understanding of the key principles of pharmacovigilance. Packed full of examples illustrating drug safety issues it not only covers the processes involved, but the regulatory aspects and ethical and societal considerations of pharmacovigilance. Covering the basics step-by-step, this book is perfect for beginners and is essential reading for those new to drug safety departments and pharmaceutical medicine students. The second edition is thoroughly revised and updated throughout and includes a new chapter on clinical aspects of pharmacovigilance.
Categories: Medical

Drug Safety

Drug Safety

This text aims to explain the processes involved in drug surveillance and considers drug safety from the perspectives of the pharmaceutical industry, the medical profession and regulatory authorities.

Author: International Drug Surveillance Department

Publisher:

ISBN: UOM:39015022248176

Category: Dispensatories

Page: 126

View: 982

The monitoring of drug safety is an issue that affects most health care professionals. This text aims to explain the processes involved in drug surveillance and considers drug safety from the perspectives of the pharmaceutical industry, the medical profession and regulatory authorities.
Categories: Dispensatories

Cobert s Manual of Drug Safety and Pharmacovigilance

Cobert s Manual of Drug Safety and Pharmacovigilance

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, ...

Author: Barton Cobert

Publisher:

ISBN: 9811215235

Category: Medical

Page: 524

View: 250

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.
Categories: Medical

Cobert s Manual of Drug Safety and Pharmacovigilance

Cobert s Manual of Drug Safety and Pharmacovigilance

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 ...

Author: Barton Cobert

Publisher: Jones & Bartlett Publishers

ISBN: 9780763791605

Category: Medical

Page: 408

View: 739

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.
Categories: Medical

Issues in Drug Management Toxicology Monitoring Resistance and Safety 2011 Edition

Issues in Drug Management  Toxicology  Monitoring  Resistance  and Safety  2011 Edition

... events to monitor.' According to a study from Rotterdam, Netherlands, “Data
mining on electronic health records (EHRs) has emerged as a promising
complementary method for post-marketing drug safety surveillance. The EU-ADR
project, ...

Author:

Publisher: ScholarlyEditions

ISBN: 9781464967092

Category: Medical

Page: 363

View: 926

Issues in Drug Management, Toxicology, Monitoring, Resistance, and Safety: 2011 Edition is a ScholarlyEditions™ eBook that delivers timely, authoritative, and comprehensive information about Drug Management, Toxicology, Monitoring, Resistance, and Safety. The editors have built Issues in Drug Management, Toxicology, Monitoring, Resistance, and Safety: 2011 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Drug Management, Toxicology, Monitoring, Resistance, and Safety in this eBook to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Issues in Drug Management, Toxicology, Monitoring, Resistance, and Safety: 2011 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/.
Categories: Medical

Cobert s Manual of Drug Safety and Pharmacovigilance Third Edition

Cobert s Manual of Drug Safety and Pharmacovigilance  Third Edition

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, ...

Author: Barton Cobert

Publisher: World Scientific Publishing Company

ISBN: 9813278846

Category: Medical

Page: 524

View: 329

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.
Categories: Medical

Stephens Detection of New Adverse Drug Reactions

Stephens  Detection of New Adverse Drug Reactions

This book explores the methods used to investigate new adverse drug reactions, discussing all elements from the scientific background and animal toxicology through to worldwide regulatory and ethical issues.

Author: John Talbot

Publisher: John Wiley & Sons

ISBN: 9780470092651

Category: Medical

Page: 762

View: 957

A key text for all those involved in pharmacovigilance. Detection of new adverse drug reactions is fundamental to the protection of patients from harm that may occur as a result of medication. This book explores the methods used to investigate new adverse drug reactions, discussing all elements from the scientific background and animal toxicology through to worldwide regulatory and ethical issues. Stephens' Detection of New Adverse Drug Reactions provides comprehensive and up-to-date coverage of material fundamentally important to all those active in the field, whether they work in the pharmaceutical industry, drug regulatory authorities or in academia. The fifth edition of this classic reference work includes new chapters on: vaccine safety surveillance managing drug safety issues with marketed products operational aspects of drug safety function safety of biotechnology products future of pharmacovigilance Reviews of previous editions: "This book surpasses all its educational aims. Not only is the subject matter covered comprehensively but the material is presented in a very user-friendly manner. The editors have succeeded in producing a highly-specific, definitive reference book which doubles as a most enjoyable read." —Commended by the 1999 BMA Medical Book Competition "For anyone entering the field of adverse reaction monitoring one could not wish for a better primer" —International Journal of Risk and Safety in Medicine
Categories: Medical

Issues in Drug Management Toxicology Monitoring Resistance and Safety 2013 Edition

Issues in Drug Management  Toxicology  Monitoring  Resistance  and Safety  2013 Edition

For more information on this research see: CORAL: Binary Classifications (Active/
Inactive) for Liver-Related Adverse Effects of Drugs. Current Drug Safety, 2012;7(
4):257-61. (Bentham Science Publishers - www.benthamscience.com; Current ...

Author:

Publisher: ScholarlyEditions

ISBN: 9781490109176

Category: Medical

Page: 406

View: 859

Issues in Drug Management, Toxicology, Monitoring, Resistance, and Safety: 2013 Edition is a ScholarlyEditions™ book that delivers timely, authoritative, and comprehensive information about Drug Testing and Analysis. The editors have built Issues in Drug Management, Toxicology, Monitoring, Resistance, and Safety: 2013 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Drug Testing and Analysis in this book to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Issues in Drug Management, Toxicology, Monitoring, Resistance, and Safety: 2013 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/.
Categories: Medical

Drug Safety

Drug Safety

Drug Safety

Author: Michel Auriche

Publisher: Elsevier

ISBN: 9781483140377

Category: Medical

Page: 328

View: 936

Drug Safety
Categories: Medical

Promoting Safety of Medicines for Children

Promoting Safety of Medicines for Children

This book will be of interest to all health care professionals, medicine regulatory authorities, pharmacovigilance centers, academia, the pharmaceutical industry and policy-makers.

Author: World Health Organization

Publisher: World Health Organization

ISBN: 9789241563437

Category: Medical

Page: 59

View: 592

Monitoring the safety of medicine use in children is of paramount importance since, during the clinical development of medicines, only limited data on this aspect are generated through clinical trials. Use of medicines outside the specifications described in the license (e.g. in terms of formulation, indications, contraindications or age) constitutes off-label and off-license use and these are a major area of concern. These guidelines are intended to improve awareness of medicine safety issues among everyone who has an interest in the safety of medicines in children and to provide guidance on effective systems for monitoring medicine safety in the pediatric populations. This book will be of interest to all health care professionals, medicine regulatory authorities, pharmacovigilance centers, academia, the pharmaceutical industry and policy-makers. Systems for monitoring medicine safety are described in Annex 1. Pharmacovigilance methods and some examples of recent information on adverse reactions to marketed medicines are discussed in Annex 2.--Publisher's description.
Categories: Medical

Challenges for the FDA

Challenges for the FDA

Challenges for the FDA: The Future of Drug Safety, Workshop Summary explains the presentations and discussions in seven key areas: addressing the FDA's resource challenges; strengthening the scientific base of the agency; integrating pre- ...

Author: Institute of Medicine

Publisher: National Academies Press

ISBN: 0309179440

Category: Medical

Page: 128

View: 159

As the principal agency regulating food, drugs, medical devices, and biological products used by Americans, the U.S. Food and Drug Administration (FDA) serves one of the most critical consumer protection functions of the federal government. The FDA's reach is enormous, regulating products that represent roughly 25 percent of all consumer spending in the United States. Since 1992, however, federal funding for the agency has diminished, and the FDA's Center for Drug Evaluation and Research (CDER) currently relies on the fees it receives from the industry it regulates to fund the majority of its drug regulation functions. Prescription drug safety is receiving heightened press coverage and congressional scrutiny as a result of recent, highly publicized events, such as the recall of Vioxx because of its link to heart attacks, and the link between certain antidepressants (selective serotonin reuptake inhibitors, or SSRIs) and an increased risk of suicidal ideation in children. To address these concerns, the FDA in 2005 commissioned the Institute of Medicine (IOM) to conduct an independent assessment of the current U.S. drug safety system. In September 2006, the IOM committee released its report-The Future of Drug Safety: Promoting and Protecting the Health of the Public-which included 25 recommendations for improving the system for drug safety review. The committee identified four major vulnerabilities in the U.S. drug safety system: (1) chronic underfunding; (2) organization problems, particularly inadequate integration of pre-and postmarket data review; (3) a range of technical problems related to the insufficient quantity and quality of postmarket data and inadequate capability to systematically monitor the risks and benefits of drugs after marketing; and (4) unclear regulatory authority and insufficiently flexible regulatory tools. Since the IOM report was issued, the FDA has taken a number of steps toward implementing the recommended improvements. Like many government agencies, however, the FDA is financially strained by its existing responsibilities, and fully implementing the recommended improvements to the drug safety system would require significant financial commitments.The IOM report addressed some of the costs associated with its recommendations, but left many unanswered questions about the resources required to fully achieve the envisioned improvements. To better understand the types and magnitude of resources required to achieve the goals of the IOM report, the IOM's Forum on Drug Discovery, Development, and Translation convened a 1-day symposium in March 2007. Challenges for the FDA: The Future of Drug Safety, Workshop Summary explains the presentations and discussions in seven key areas: addressing the FDA's resource challenges; strengthening the scientific base of the agency; integrating pre- and postmarket review; enhancing postmarket safety monitoring; conducting confirmatory drug safety and efficacy studies; enhancing the value of clinical trial registration; and enhancing the FDA's postmarket regulation and enforcement.
Categories: Medical

Mann s Pharmacovigilance

Mann s Pharmacovigilance

This new third edition covers the regulatory basis and the practice of pharmacovigilance and spontaneous adverse event reporting throughout the world.

Author: Elizabeth B. Andrews

Publisher: John Wiley & Sons

ISBN: 9781118820148

Category: Medical

Page: 872

View: 298

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.
Categories: Medical

Drug Safety in Developing Countries

Drug Safety in Developing Countries

In addition to previous suggestions, there is need for monitoring of ADEs
associated with immunization (vaccine safety surveillance), drug-induced
adverse birth outcomes (pregnancy registry), monitoring of medical devices (
materiovigilance), ...

Author: Yaser Mohammed Al-Worafi

Publisher: Academic Press

ISBN: 9780128204122

Category: Business & Economics

Page: 686

View: 672

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
Categories: Business & Economics

Drug Safety

Drug Safety

Monitoring adverse reactions to new drugs: “restricted release” or “monitored
release”? BMJ 1: 691– 2. Layton D ... Safety profile of celecoxib as used in
general practice in England: results of a prescriptionevent monitoring study. EurJ
Clin ...

Author: Nigel S. B. Rawson

Publisher: FriesenPress

ISBN: 9781460291016

Category: Medical

Page: 272

View: 234

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.
Categories: Medical

Quantitative Evaluation of Safety in Drug Development

Quantitative Evaluation of Safety in Drug Development

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.

Author: Qi Jiang

Publisher: CRC Press

ISBN: 9781466555457

Category: Mathematics

Page: 382

View: 241

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.
Categories: Mathematics

Issues in Drug Management Toxicology Monitoring Resistance and Safety 2012 Edition

Issues in Drug Management  Toxicology  Monitoring  Resistance  and Safety  2012 Edition

Issues in Drug Management, Toxicology, Monitoring, Resistance, and Safety: 2012 Edition is a ScholarlyBrief™ that delivers timely, authoritative, comprehensive, and specialized information about Toxicology and Pharmacology in a concise ...

Author:

Publisher: ScholarlyEditions

ISBN: 9781481649452

Category: Medical

Page: 47

View: 655

Issues in Drug Management, Toxicology, Monitoring, Resistance, and Safety: 2012 Edition is a ScholarlyBrief™ that delivers timely, authoritative, comprehensive, and specialized information about Toxicology and Pharmacology in a concise format. The editors have built Issues in Drug Management, Toxicology, Monitoring, Resistance, and Safety: 2012 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Toxicology and Pharmacology in this eBook to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Issues in Drug Management, Toxicology, Monitoring, Resistance, and Safety: 2012 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/.
Categories: Medical