Post Authorization Safety Studies Of Medicinal Products

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Post-Authorization Safety Studies of Medicinal Products

Author : Ayad K. Ali
Publisher : Academic Press
ISBN 13 : 0128092084
Total Pages : 364 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Post-Authorization Safety Studies of Medicinal Products by : Ayad K. Ali

Download or read book Post-Authorization Safety Studies of Medicinal Products written by Ayad K. Ali and published by Academic Press. This book was released on 2018-06-27 with total page 364 pages. Available in PDF, EPUB and Kindle. Book excerpt: Post-Authorization Safety Studies of Medicinal Products: The PASS Book bridges the gap in the literature by providing a complete look at post-authorization safety studies and important pharmacoepidemiology and pharmacovigilance aspects. It covers various types and limitations of active surveillance programs, including the use of large databases and disparate data sources for rapid signal detection, as well as novel and advanced design and analysis approaches for causal interference from observational data. This book serves as an important reference for pharmacovigilance scientists and pharmacoepidemiologists who are searching for the appropriate study design to answer safety research questions. Readers will be able to effectively and efficiently design and interpret findings from post-authorization safety studies with the goal of improving the benefit-risk balance of a drug in order to optimize patient safety. Discusses all types of observational studies in post-marketing drug safety assessment, from spontaneous reporting systems, to pragmatic trials, with examples from real-world settings Presents various types of post-authorization safety studies Offers solutions to the common challenges in the design and conduct of these studies Highlights active surveillance programs, including common data models for rapid signal detection of drug safety issues

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.

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.

Mann's Pharmacovigilance

Author : Elizabeth B. Andrews
Publisher : John Wiley & Sons
ISBN 13 : 0470671041
Total Pages : 878 pages
Book Rating : 4.4/5 (76 download)

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Book Synopsis Mann's Pharmacovigilance by : Elizabeth B. Andrews

Download or read book Mann's Pharmacovigilance written by Elizabeth B. Andrews and published by John Wiley & Sons. This book was released on 2014-06-23 with total page 878 pages. Available in PDF, EPUB and Kindle. Book excerpt: Highly Commended at the BMA Medical Book Awards 2015 Mann’s Pharmacovigilance is the definitive reference for the science of detection, assessment, understanding and prevention of the adverse effects of medicines, including vaccines and biologics. Pharmacovigilance is increasingly important in improving drug safety for patients and reducing risk within the practice of pharmaceutical medicine. This new third edition covers the regulatory basis and the practice of pharmacovigilance and spontaneous adverse event reporting throughout the world. It examines signal detection and analysis, including the use of population-based databases and pharmacoepidemiological methodologies to proactively monitor for and assess safety signals. It includes chapters on drug safety practice in specific organ classes, special populations and special products, and new developments in the field. From an international team of expert editors and contributors, Mann’s Pharmacovigilance is a reference for everyone working within pharmaceutical companies, contract research organisations and medicine regulatory agencies, and for all researchers and students of pharmaceutical medicine. The book has been renamed in honor of Professor Ronald Mann, whose vision and leadership brought the first two editions into being, and who dedicated his long career to improving the safety and safe use of medicines.

Development and Control of Medicines and Medical Devices

Author : Robin J. Harman
Publisher :
ISBN 13 :
Total Pages : 280 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Development and Control of Medicines and Medical Devices by : Robin J. Harman

Download or read book Development and Control of Medicines and Medical Devices written by Robin J. Harman and published by . This book was released on 2004 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new title describes the tests and processes undertaken to bring new medicines and medical devices to the market, and the work of the government agencies which ensure products of the highest standard. The text covers the controls to prove quality, safety, and efficacy prior to marketing, and postmarketing pharmacovigilance requirements. The different European registration processes for both medicines and medical devices are explained. Important ethical issues in their development are also reviewed. The role of the UK and pan-European regulatory authorities for medicines and medicinal devices (the MHRA and the EMEA), and of the National Institute for Clinical Excellence (NICE), are explained. A review of the ICH process, and of the activities of the US FDA and the World Health Organization (WHO) in drug and device regulation illustrate how other countries control these products. Providing a comprehensive single-volume review, Development and Control of Medicines and Medicinal Devices is an invaluable reference for all students undertaking healthcare studies and for all pharmacists. It is also an essential source for all working in the pharmaceutical and medical devices industries and in government agencies involved in the control of medicines and medical devices.

An Introduction to Pharmacovigilance

Author : Patrick Waller
Publisher : John Wiley & Sons
ISBN 13 : 1119289750
Total Pages : 192 pages
Book Rating : 4.1/5 (192 download)

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Book Synopsis An Introduction to Pharmacovigilance by : Patrick Waller

Download or read book An Introduction to Pharmacovigilance written by Patrick Waller and published by John Wiley & Sons. This book was released on 2017-02-14 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Practical Aspects of Signal Detection in Pharmacovigilance

Author : Council for International Organizations of Medical Sciences (CIOMS)
Publisher : Cioms
ISBN 13 : 9789290360827
Total Pages : 0 pages
Book Rating : 4.3/5 (68 download)

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Book Synopsis Practical Aspects of Signal Detection in Pharmacovigilance by : Council for International Organizations of Medical Sciences (CIOMS)

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.

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.

Cancer Policy: Pharmaceutical Safety

Author : June M. McKoy
Publisher : Springer
ISBN 13 : 3319438964
Total Pages : 128 pages
Book Rating : 4.3/5 (194 download)

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Book Synopsis Cancer Policy: Pharmaceutical Safety by : June M. McKoy

Download or read book Cancer Policy: Pharmaceutical Safety written by June M. McKoy and published by Springer. This book was released on 2018-12-14 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cancer Policy: Pharmaceutical Safety provides invaluable information on the interesting and compelling field of cancer drug safety. Identifying and understanding high-priority policy issues and key pharmacovigilance strategies is of paramount importance. In this volume, outstanding and original chapters provide an overview and synthesis of the latest thoughts and findings relating to drug safety in the cancer domain. Topics include natural language processing and pharmacovigilance of alternative cancer pharmaceuticals. The information presented in this volume will improve understanding of emerging strategies to identify adverse drug reactions and drug-drug interactions within the cancer setting and will highlight policies that have been instituted to improve cancer patient safety. In summary, Cancer Policy: Pharmaceutical Safety explores many of the important areas of pharmacovigilance research in oncology.

Principles of Safety Pharmacology

Author : Michael K. Pugsley
Publisher : Springer
ISBN 13 : 366246943X
Total Pages : 477 pages
Book Rating : 4.6/5 (624 download)

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Book Synopsis Principles of Safety Pharmacology by : Michael K. Pugsley

Download or read book Principles of Safety Pharmacology written by Michael K. Pugsley and published by Springer. This book was released on 2015-06-19 with total page 477 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book illustrates, in a comprehensive manner, the most current areas of importance to Safety Pharmacology, a burgeoning unique pharmacological discipline with important ties to academia, industry and regulatory authorities. It provides readers with a definitive collection of topics containing essential information on the latest industry guidelines and overviews current and breakthrough topics in both functional and molecular pharmacology. An additional novelty of the book is that it constitutes academic, pharmaceutical and biotechnology perspectives for Safety Pharmacology issues. Each chapter is written by an expert in the area and includes not only a fundamental background regarding the topic but also detailed descriptions of currently accepted, validated models and methods as well as innovative methodologies used in drug discovery.

Safety Pharmacology in Pharmaceutical Development

Author : Shayne C. Gad
Publisher : CRC Press
ISBN 13 : 1439845689
Total Pages : 213 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Safety Pharmacology in Pharmaceutical Development by : Shayne C. Gad

Download or read book Safety Pharmacology in Pharmaceutical Development written by Shayne C. Gad and published by CRC Press. This book was released on 2012-04-26 with total page 213 pages. Available in PDF, EPUB and Kindle. Book excerpt: Safety pharmacology is the evaluation and study of the pharmacological effects of a potential drug that are unrelated to the desired therapeutic effect. These effects often present a hazard-particularly in individuals with compromised or limited organ system functions.Safety Pharmacology in Pharmaceutical Development: Approval and Post Marketing Su

Dictionary of Pharmacovigilance

Author : Amer Alghabban
Publisher :
ISBN 13 :
Total Pages : 552 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Dictionary of Pharmacovigilance by : Amer Alghabban

Download or read book Dictionary of Pharmacovigilance written by Amer Alghabban and published by . This book was released on 2004 with total page 552 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmacovigilance is, in essence, the process of monitoring the everyday use of medicines to identify previously unrecognised adverse drug reactions, thereby assessing their risk/benefit balance in order to determine what action, if any, is necessary to improve their safe use. As a discipline, pharmacovigilance impacts on many specialist areas such as pharmacoepidemiology, medical practice, public health, but is most intimately linked to clinical research, development and drug licensing. The discipline along with its operational and legal facets, for both regulatory authorities and pharmaceutical industry, envelop colossal terminology that has precise legal and scientific significance. Such terminology may vary from country to country, or more confusingly, different countries may use identical or similar abbreviations, terms or phrases to mean different entities.The Dictionary of Pharmacovigilance contains a comprehensive list of abbreviations, terms and phrases (in English) giving definitions of commonly (and rarely) encountered pharmacovigilance terms. Examples include: Absolute Risk Increase (ARI), Bayesian Confidence Propagation Neural Network (BCPNN), Confounding Factor, Case narrative, Causality Assessment, Company Core Safety Information (CCSI), Data mining, 15-day report, Rechallenge, Directive 2001/83/EC, EU Birth Date, Expert report, FDA Form 1639, Historical control, Number Needed to Harm, Toxikinetics, Post-Marketing Surveillance, Qualified Person, Source Data Verification (SDV), Spontaneous Reporting, Vaccine Adverse Event Reporting System (VAERS), Warning Letter, Product Withdrawal.

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.

Sharing Clinical Trial Data

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 236 pages
Book Rating : 4.3/5 (93 download)

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Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine

Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Modern Methods of Clinical Investigation

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309042860
Total Pages : 241 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Modern Methods of Clinical Investigation by : Institute of Medicine

Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

Current Challenges in Pharmacovigilance

Author : World Health Organization
Publisher :
ISBN 13 : 9789290360742
Total Pages : 381 pages
Book Rating : 4.3/5 (67 download)

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Book Synopsis Current Challenges in Pharmacovigilance by : World Health Organization

Download or read book Current Challenges in Pharmacovigilance written by World Health Organization and published by . This book was released on 2001-01-01 with total page 381 pages. Available in PDF, EPUB and Kindle. Book excerpt: In spite of recent progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines consensus is needed on standards for many difficult aspects of day-to-day pharmacovigilance that continue to pose problems for both the pharmaceutical industry and drug regulators. The CIOMS V Working Group has generated proposals for pragmatic approaches to dealing with such issues as: classification and handling of individual safety case reports from a variety of sources (spontaneous consumer reports solicited reports literature the Internet observational studies and secondary data bases disease and other registries regulatory ADR databases and licensor-licensee interactions); new approaches to case management and regulatory reporting practices (proper clinical evaluation of cases incidental vs other events patient and reporter identifiability seriousness criteria expectedness criteria case follow-up criteria and the role and structure of case narratives); improvements and efficiencies in the format content and reporting of periodic safety update reports (PSURs) (including results of an industry survey on PSUR workloads and practices; proposals for high case volume and long time-period reports simplification of certain PSURs summary bridging reports addendum reports license renewal reports for EU and Japan dealing with old products and other technical details); determination and use of population exposure (denominator) data (sources of data and a guide to analytical approaches for a variety of circumstances).The Group has also taken stock of the current state of expedited and periodic clinical safety reporting requirements around the world with summary data on regulations from more than 60 countries. Recommendations are made for enhancing the harmonization steps already taken as a result of previous CIOMS publications and the ICH process. In addition to dealing with unfinished and unresolved issues from previous CIOMS initiatives the report covers many emerging topics such as those involving new technologies. Its 20 Appendices provide a wealth of detailed explanations and reference information. It is the most comprehensive and recent treatment of difficult pharmacovigilance issues affecting the working practices and systems of drug safety and other pharmaceutical professionals.

Medical Devices and the Public's Health

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309212456
Total Pages : 318 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Medical Devices and the Public's Health by : Institute of Medicine

Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.