Shaping With Data Using Pharmacoepidemiology To Shape Pharmaceutical Policy And Clinical Decision Making
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Author |
: Mina Tadrous |
Publisher |
: Frontiers Media SA |
Total Pages |
: 164 |
Release |
: 2022-11-15 |
ISBN-10 |
: 9782832505915 |
ISBN-13 |
: 2832505910 |
Rating |
: 4/5 (15 Downloads) |
Synopsis Shaping With Data: Using Pharmacoepidemiology to Shape Pharmaceutical Policy and Clinical Decision-Making by : Mina Tadrous
Author |
: Miriam Sturkenboom |
Publisher |
: Springer Nature |
Total Pages |
: 276 |
Release |
: 2021-01-12 |
ISBN-10 |
: 9783030514556 |
ISBN-13 |
: 3030514552 |
Rating |
: 4/5 (56 Downloads) |
Synopsis Databases for Pharmacoepidemiological Research by : Miriam Sturkenboom
This book allows readers to gain an in-depth understanding of the role of real-world data in pharmacoepidemiology, and highlights the strengths and limitations of the respective databases with regard to pharmacoepidemiological research. Over the past decade, the increasing use of real-world data in pharmacoepidemiological research has been accompanied by a growing recognition of the value of real-world evidence in clinical and regulatory decision-making. Electronic healthcare databases allow analyses of drug and vaccine utilization in routine care after approval, as well as investigations of their comparative effectiveness and safety. They are especially useful for the identification of rare risks and rare drug exposures over long periods of time, and as such sustainably extend the basis for drug safety research. This book provides an introduction to the role of real-world data in pharmacoepidemiological research and the main developments in the last 15 years. It also offers a comprehensive overview of the general classification characteristics of databases, together with their strengths and limitations, and a detailed description of 21 individual databases, written by professionals who work with or maintain them.
Author |
: Brian L. Strom |
Publisher |
: John Wiley & Sons |
Total Pages |
: 977 |
Release |
: 2012-03-05 |
ISBN-10 |
: 9780470654750 |
ISBN-13 |
: 0470654759 |
Rating |
: 4/5 (50 Downloads) |
Synopsis Pharmacoepidemiology by : Brian L. Strom
Now in its fifth edition, Pharmacoepidemiology defines the discipline and provides the most comprehensive guidance of any book on the topic. Written by world renowned experts in the field, this valuable text surveys the research designs and sources of data available for pharmacoepidemiologic research, and provides descriptions of various automated data systems, along with the advantages and disadvantages of each. Incorporating perspectives from academia, industry and regulatory agencies, this book provides detailed insights into all aspects of pharmacoepidemiology.
Author |
: Institute of Medicine |
Publisher |
: National Academies Press |
Total Pages |
: 334 |
Release |
: 2009-03-24 |
ISBN-10 |
: 9780309124997 |
ISBN-13 |
: 0309124999 |
Rating |
: 4/5 (97 Downloads) |
Synopsis Beyond the HIPAA Privacy Rule by : Institute of Medicine
In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.
Author |
: Agency for Health Care Research and Quality (U.S.) |
Publisher |
: Government Printing Office |
Total Pages |
: 236 |
Release |
: 2013-02-21 |
ISBN-10 |
: 9781587634239 |
ISBN-13 |
: 1587634236 |
Rating |
: 4/5 (39 Downloads) |
Synopsis Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide by : Agency for Health Care Research and Quality (U.S.)
This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. 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. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)
Author |
: National Academies of Sciences, Engineering, and Medicine |
Publisher |
: National Academies Press |
Total Pages |
: 483 |
Release |
: 2017-09-28 |
ISBN-10 |
: 9780309459570 |
ISBN-13 |
: 0309459575 |
Rating |
: 4/5 (70 Downloads) |
Synopsis Pain Management and the Opioid Epidemic by : National Academies of Sciences, Engineering, and Medicine
Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
Author |
: Michael K. Pugsley |
Publisher |
: Springer |
Total Pages |
: 477 |
Release |
: 2015-06-19 |
ISBN-10 |
: 9783662469439 |
ISBN-13 |
: 366246943X |
Rating |
: 4/5 (39 Downloads) |
Synopsis Principles of Safety Pharmacology by : Michael K. Pugsley
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.
Author |
: Harry Yang |
Publisher |
: CRC Press |
Total Pages |
: 191 |
Release |
: 2021-01-11 |
ISBN-10 |
: 9780429676826 |
ISBN-13 |
: 0429676824 |
Rating |
: 4/5 (26 Downloads) |
Synopsis Real-World Evidence in Drug Development and Evaluation by : Harry Yang
Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book systematically covering the latest development in the field. Written specifically for pharmaceutical practitioners, Real-World Evidence in Drug Development and Evaluation, presents a wide range of RWE applications throughout the lifecycle of drug product development. With contributions from experienced researchers in the pharmaceutical industry, the book discusses at length RWE opportunities, challenges, and solutions. Features Provides the first book and a single source of information on RWE in drug development Covers a broad array of topics on outcomes- and value-based RWE assessments Demonstrates proper Bayesian application and causal inference for real-world data (RWD) Presents real-world use cases to illustrate the use of advanced analytics and statistical methods to generate insights Offers a balanced discussion of practical RWE issues at hand and technical solutions suitable for practitioners with limited data science expertise
Author |
: Agency for Healthcare Research and Quality/AHRQ |
Publisher |
: Government Printing Office |
Total Pages |
: 385 |
Release |
: 2014-04-01 |
ISBN-10 |
: 9781587634338 |
ISBN-13 |
: 1587634333 |
Rating |
: 4/5 (38 Downloads) |
Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ
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.
Author |
: Renee J. G. Arnold |
Publisher |
: CRC Press |
Total Pages |
: 259 |
Release |
: 2016-04-19 |
ISBN-10 |
: 9781420084405 |
ISBN-13 |
: 1420084402 |
Rating |
: 4/5 (05 Downloads) |
Synopsis Pharmacoeconomics by : Renee J. G. Arnold
The pharmaceutical industry is almost boundless in its ability to supply new drug therapies, but how does one decide which are the best medicines to use within restricted budgets? With particular emphasis on modeling, methodologies, data sources, and application to real-world dilemmas, Pharmacoeconomics: From Theory to Practice provides an introduc