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Pragmatic Randomized Clinical Trials

Pragmatic Randomized Clinical Trials
Using Primary Data Collection and Electronic Health Records

by Cynthia J. Girman,Mary E. Ritchey

  • Publisher : Academic Press
  • Release : 2021-04-23
  • Pages : 498
  • ISBN : 0128176644
  • Language : En, Es, Fr & De
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Pragmatic Randomized Clinical Trials Using Primary Data Collection and Electronic Health Records addresses the practical aspects and challenges of the design, implementation, and dissemination of pragmatic randomized trials, also sometimes referred to as practical or hybrid randomized trials. While less restrictive and more generalizable than traditional randomized controlled trials, such trials have specific challenges which are addressed in this book. The book contains chapters encompassing common designs along with advantages and limitations of such designs, analytic aspects in planning trials and estimating sample size, and how to use patient partners to help design and operationalize pragmatic randomized trials. Pragmatic trials conducted using primary data collection and trials embedded in electronic health records - including electronic medical records and administrative insurance claims - are addressed. This comprehensive resource is valuable not only for pharmacoepidemiologists, biostatisticians and clinical researchers, but also across the biomedical field for those who are interested in applying pragmatic randomized clinical trials in their research. • Addresses typical designs and challenges of pragmatic randomized clinical trials (pRCTs) • Encompasses analytic aspects of such trials • Discusses real cases on operational challenges in launching and conducting pRCTs in electronic health records

Clinical Trials

Clinical Trials
A Book

by Timothy M. Pawlik,Julie A. Sosa

  • Publisher : Springer Nature
  • Release : 2020-03-10
  • Pages : 258
  • ISBN : 3030354881
  • Language : En, Es, Fr & De
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This extensively revised second edition is a unique and portable handbook focusing on clinical trials in surgery. It includes new educational materials addressing the rapid evolution of novel research methodologies in basic science, clinical and educational research. The underlying principles of clinical trials, trial design, the development of a study cohort, statistics, data safety, data monitoring, and trial publication for device and drug trials are also discussed. Clinical Trials provides a comprehensive resource on clinical trials in surgery and describes all the stages of a clinical trial from generating a hypothesis through to trial publication and is a valuable resource for all practicing and trainee academic surgeons.

Pharmacoepidemiology

Pharmacoepidemiology
A Book

by Brian L. Strom,Stephen E. Kimmel,Sean Hennessy

  • Publisher : John Wiley & Sons
  • Release : 2019-10-23
  • Pages : 1208
  • ISBN : 1119413427
  • Language : En, Es, Fr & De
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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.

Prevention Practice in Primary Care

Prevention Practice in Primary Care
A Book

by Sherri Sheinfeld Gorin

  • Publisher : Oxford University Press
  • Release : 2013-11
  • Pages : 336
  • ISBN : 0195373014
  • Language : En, Es, Fr & De
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Prevention Practice in Primary Care systematically explores state-of-the-art practical approaches to effective prevention in primary care. Guided by theory and evidence, the book reviews approaches to risk factor identification and modification for the major causes of mortality in adulthood, including cancer, stroke, and cardiovascular disease.

Clinical and Translational Science

Clinical and Translational Science
Principles of Human Research

by David Robertson,Gordon H. Williams

  • Publisher : Academic Press
  • Release : 2016-11-25
  • Pages : 808
  • ISBN : 012802111X
  • Language : En, Es, Fr & De
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Clinical and Translational Science: Principles of Human Research, Second Edition, is the most authoritative and timely resource for the broad range of investigators taking on the challenge of clinical and translational science, a field that is devoted to investigating human health and disease, interventions, and outcomes for the purposes of developing new treatment approaches, devices, and modalities to improve health. This updated second edition has been prepared with an international perspective, beginning with fundamental principles, experimental design, epidemiology, traditional and new biostatistical approaches, and investigative tools. It presents complete instruction and guidance from fundamental principles, approaches, and infrastructure, especially for human genetics and genomics, human pharmacology, research in special populations, the societal context of human research, and the future of human research. The book moves on to discuss legal, social, and ethical issues, and concludes with a discussion of future prospects, providing readers with a comprehensive view of this rapidly developing area of science. Introduces novel physiological and therapeutic strategies for engaging the fastest growing scientific field in both the private sector and academic medicine Brings insights from international leaders into the discipline of clinical and translational science Addresses drug discovery, drug repurposing and development, innovative and improved approaches to go/no-go decisions in drug development, and traditional and innovative clinical trial designs

Oxford Textbook of Global Public Health

Oxford Textbook of Global Public Health
A Book

by Roger Detels,Martin Gulliford,Quarraisha Abdool Karim,Chorh Chuan Tan

  • Publisher : Oxford University Press
  • Release : 2017-09-28
  • Pages : 1728
  • ISBN : 019881013X
  • Language : En, Es, Fr & De
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Sixth edition of the hugely successful, internationally recognised textbook on global public health and epidemiology, with 3 volumes comprehensively covering the scope, methods, and practice of the discipline.

Real-World Evidence Generation and Evaluation of Therapeutics

Real-World Evidence Generation and Evaluation of Therapeutics
Proceedings of a Workshop

by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation

  • Publisher : National Academies Press
  • Release : 2017-07-05
  • Pages : 102
  • ISBN : 0309455650
  • Language : En, Es, Fr & De
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The volume and complexity of information about individual patients is greatly increasing with use of electronic records and personal devices. Potential effects on medical product development in the context of this wealth of real-world data could be numerous and varied, ranging from the ability to determine both large-scale and patient-specific effects of treatments to the ability to assess how therapeutics affect patients' lives through measurement of lifestyle changes. In October 2016, the National Academies of Sciences, Engineering, and Medicine held a workshop to facilitate dialogue among stakeholders about the opportunities and challenges for incorporating real-world evidence into all stages in the process for the generation and evaluation of therapeutics. Participants explored unmet stakeholder needs and opportunities to generate new kinds of evidence that meet those needs. This publication summarizes the presentations and discussions from the workshop.

Textbook of Pharmacoepidemiology

Textbook of Pharmacoepidemiology
A Book

by Brian L. Strom,Stephen E. Kimmel,Sean Hennessy

  • Publisher : John Wiley & Sons
  • Release : 2013-07-08
  • Pages : 480
  • ISBN : 1118344847
  • Language : En, Es, Fr & De
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Textbook of Pharmacoepidemiology, Second Edition, provides an introduction to pharmacoepidemiology and the data sources, methods and applications used in clinical research, the pharmaceutical industry and regulatory agencies. Drawing upon the fifth edition of the authoritative reference, Pharmacoepidemiology, this new edition covers the key learning requirements of the discipline. The textbook provides an introduction to pharmacoepidemiology, pharmacoepidemiological data sources, special issues in methodology, special applications and future developments in the field. Updated learning features such as case studies, key points and Suggested Further Reading are included throughout the text. Textbook of Pharmacoepidemiology is a practical educational resource for upper-level undergraduates, graduate students, post-doctoral fellows in schools of public health, pharmacy and medicine, and for everyone learning and working in pharmacoepidemiology.

The Future of Health Economics

The Future of Health Economics
A Book

by Olivier Ethgen,Ulf Staginnus

  • Publisher : Taylor & Francis
  • Release : 2016-10-14
  • Pages : 284
  • ISBN : 1317031121
  • Language : En, Es, Fr & De
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The pharmaceutical industry faces a well-documented perfect storm: on the one hand, the patent cliff; the lack of new blockbusters and, on the other, economic pressure on pricing from markets with growing expectations and shrinking budgets. In the face of such pressure, traditional health economics models no longer seem appropriate and yet what do we have to replace them? The growing focus on 'value' and 'cost effectiveness' are evidence of new emerging thinking although, even here, with the shift from medicine as cure to medicine as palliative, as a treatment for chronic illness and with the growing emphasis on preventative approaches, the landscape is complex and challenging. The Future of Health Economics offers a window into some of the most influential emerging issues in pharmacoeconomics; issues such as risk-sharing and alternative pricing models or the potential impact of radical new approaches such as personalized medicine; as well as exploring the changing role of government and regulators. Ulf Staginnus and Olivier Ethgen, themselves two of the most well-regarded practitioners in this field, have brought together some leading-edge thinkers from industry and academia around the world to provide the industry, policy-makers, regulators, health practitioners and academics with the raw material for their future scenarios.

Capturing Social and Behavioral Domains and Measures in Electronic Health Records

Capturing Social and Behavioral Domains and Measures in Electronic Health Records
Phase 2

by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Recommended Social and Behavioral Domains and Measures for Electronic Health Records

  • Publisher : National Academies Press
  • Release : 2015-01-08
  • Pages : 374
  • ISBN : 0309312450
  • Language : En, Es, Fr & De
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Determinants of health - like physical activity levels and living conditions - have traditionally been the concern of public health and have not been linked closely to clinical practice. However, if standardized social and behavioral data can be incorporated into patient electronic health records (EHRs), those data can provide crucial information about factors that influence health and the effectiveness of treatment. Such information is useful for diagnosis, treatment choices, policy, health care system design, and innovations to improve health outcomes and reduce health care costs. Capturing Social and Behavioral Domains and Measures in Electronic Health Records: Phase 2 identifies domains and measures that capture the social determinants of health to inform the development of recommendations for the meaningful use of EHRs. This report is the second part of a two-part study. The Phase 1 report identified 17 domains for inclusion in EHRs. This report pinpoints 12 measures related to 11 of the initial domains and considers the implications of incorporating them into all EHRs. This book includes three chapters from the Phase 1 report in addition to the new Phase 2 material. Standardized use of EHRs that include social and behavioral domains could provide better patient care, improve population health, and enable more informative research. The recommendations of Capturing Social and Behavioral Domains and Measures in Electronic Health Records: Phase 2 will provide valuable information on which to base problem identification, clinical diagnoses, patient treatment, outcomes assessment, and population health measurement.

Capturing Social and Behavioral Domains in Electronic Health Records

Capturing Social and Behavioral Domains in Electronic Health Records
Phase 1

by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Recommended Social and Behavioral Domains and Measures for Electronic Health Records

  • Publisher : National Academies Press
  • Release : 2014-06-23
  • Pages : 136
  • ISBN : 0309301130
  • Language : En, Es, Fr & De
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Substantial empirical evidence of the contribution of social and behavioral factors to functional status and the onset and progression of disease has accumulated over the past few decades. Electronic health records (EHRs) provide crucial information to providers treating individual patients, to health systems, including public health officials, about the health of populations, and to researchers about the determinants of health and the effectiveness of treatment. Inclusion of social and behavioral health domains in EHRs is vital to all three uses. The Health Information Technology for Economic and Clinical Health Act and the Patient Protection and Affordable Care Act place new importance on the widespread adoption and meaningful use of EHRs. "Meaningful use" in a health information technology context refers to the use of EHRs and related technology within a health care organization to achieve specified objectives. Achieving meaningful use also helps determine whether an organization can receive payments from the Medicare EHR Incentive Program or the Medicaid EHR Incentive Program. Capturing Social and Behavioral Domains in Electronic Health Records is the first phase of a two-phase study to identify domains and measures that capture the social determinants of health to inform the development of recommendations for meaningful use of EHRs. This report identifies specific domains to be considered by the Office of the National Coordinator, specifies criteria that should be used in deciding which domains should be included, identifies core social and behavioral domains to be included in all EHRs, and identifies any domains that should be included for specific populations or settings defined by age, socioeconomic status, race/ethnicity, disease, or other characteristics.

Landmark Papers in Psychiatry

Landmark Papers in Psychiatry
A Book

by Elizabeth Ryznar,Aderonke B. Pederson,John G. Csernansky,Mark A. Reinecke

  • Publisher : Oxford University Press, USA
  • Release : 2020-01-23
  • Pages : 444
  • ISBN : 0198836503
  • Language : En, Es, Fr & De
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Advances in the practice of psychiatry have occurred in "fits and starts" over the last several decades. These advances are evident to anyone long affiliated with the field and are best appreciated through direct experience of living through the times. These advances can also be gleaned from historical overviews in textbooks or the recollections of one's teachers and mentors. Returning to the original papers that have ushered in these changes is rarely done for various, mostly practical, reasons. Filtering through thousands of articles in psychiatry may prove daunting, access to the manuscripts may be limited (especially for papers not available electronically), and understanding their impact requires a broader context. Moreover, with so much active research currently occurring in various branches of psychiatry, current practitioners or trainees may find their attention focused on the present, and this is reinforced by electronic search algorithms, which return articles in reverse chronological order. Not surprisingly, citations for articles in virtually all fields decline precipitously for articles over five years old. As scholars and professionals, we are losing touch with our academic heritage. Yet navigating the future of psychiatry requires a firm understanding of its past. This resource serves as a guide for anyone seeking to understand the evolution of psychiatry as a scientific discipline. It does so by summarizing over 100 landmark papers in psychiatry and placing their scientific contributions within a historical context. An introductory section sets the stage for the major theoretical constructs within the field, with chapters devoted to ontology and nosology. Subsequent sections examine major facets of the theory and practice of psychiatry, such as pathogenesis of psychiatric illness, pharmacotherapy, psychotherapy, and somatic treatments. These sections are divided logically into chapters addressing important contributions to the understanding and treatment of specific disorders. A final section explores ethical considerations within each field. This framework echoes the complexity of psychiatry, which cannot be reduced to a single set of diagnoses or subspecialty categories. Highlighting the research trajectory of psychiatry, this resource will appeal to academics, trainees, and practitioners who desire a comprehensive, easy-to-read, up-to-date collection of psychiatry's pivotal moments. By understanding the challenges, inspirations, and insights from the past, readers will be better poised to address new and ongoing challenges within the field.

Managing Cyber Risk in the Financial Sector

Managing Cyber Risk in the Financial Sector
Lessons from Asia, Europe and the USA

by Ruth Taplin

  • Publisher : Routledge
  • Release : 2016-01-22
  • Pages : 194
  • ISBN : 1317383656
  • Language : En, Es, Fr & De
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Cyber risk has become increasingly reported as a major problem for financial sector businesses. It takes many forms including fraud for purely monetary gain, hacking by people hostile to a company causing business interruption or damage to reputation, theft by criminals or malicious individuals of the very large amounts of customer information (“big data”) held by many companies, misuse including accidental misuse or lack of use of such data, loss of key intellectual property, and the theft of health and medical data which can have a profound effect on the insurance sector. This book assesses the major cyber risks to businesses and discusses how they can be managed and the risks reduced. It includes case studies of the situation in different financial sectors and countries in relation to East Asia, Europe and the United States. It takes an interdisciplinary approach assessing cyber risks and management solutions from an economic, management risk, legal, security intelligence, insurance, banking and cultural perspective.

Informed Consent and Health Literacy

Informed Consent and Health Literacy
Workshop Summary

by Institute of Medicine,Board on Population Health and Public Health Practice,Roundtable on Health Literacy

  • Publisher : National Academies Press
  • Release : 2015-03-04
  • Pages : 192
  • ISBN : 0309317304
  • Language : En, Es, Fr & De
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Informed consent - the process of communication between a patient or research subject and a physician or researcher that results in the explicit agreement to undergo a specific medical intervention - is an ethical concept based on the principle that all patients and research subjects should understand and agree to the potential consequences of the clinical care they receive. Regulations that govern the attainment of informed consent for treatment and research are crucial to ensuring that medical care and research are conducted in an ethical manner and with the utmost respect for individual preferences and dignity. These regulations, however, often require - or are perceived to require - that informed consent documents and related materials contain language that is beyond the comprehension level of most patients and study participants. To explore what actions can be taken to help close the gap between what is required in the informed consent process and communicating it in a health-literate and meaningful manner to individuals, the Institute of Medicine's Roundtable on Health Literacy convened a one-day public workshop featuring presentations and discussions that examine the implications of health literacy for informed consent for both research involving human subjects and treatment of patients. Topics covered in this workshop included an overview of the ethical imperative to gain informed consent from patients and research participants, a review of the current state and best practices for informed consent in research and treatment, the connection between poor informed consent processes and minority underrepresentation in research, new approaches to informed consent that reflect principles of health literacy, and the future of informed consent in the treatment and research settings. Informed Consent and Health Literacy is the summary of the presentations and discussion of the workshop.

Comparative Effectiveness and Efficacy Research and Analysis for Practice (CEERAP)

Comparative Effectiveness and Efficacy Research and Analysis for Practice (CEERAP)
Applications in Health Care

by Francesco Chiappelli

  • Publisher : Springer Science & Business Media
  • Release : 2012-02-22
  • Pages : 194
  • ISBN : 3642231446
  • Language : En, Es, Fr & De
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Recent trends in health care across the United States and internationally have emphasized a novel approach that consists in comparing the effectiveness and efficacy of treatment interventions with a patient-centered emphasis (i.e., evidence-based health care), while ensuring cost constraints, maximizing benefits, and minimizing risks. In this book, experts in comparative effectiveness and efficacy research and analysis for practice (CEERAP) in health care in general address a range of topical issues. The emphasis is on implications for endodontics and nursing, both of which are considered in a series of detailed chapters. Commonalities and differences among CEERAP, utility-based and logic-based analysis and decision-making, and evidence-based and patient-centered practice are defined and discussed. The book concludes by examining applications for CEERAP in developing patient-centered optimal treatment interventions for the next decade.

Issues in Clinical Medicine Research and Practice: 2011 Edition

Issues in Clinical Medicine Research and Practice: 2011 Edition
A Book

by Anonim

  • Publisher : ScholarlyEditions
  • Release : 2012-01-09
  • Pages : 1210
  • ISBN : 146496484X
  • Language : En, Es, Fr & De
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Issues in Clinical Medicine Research and Practice: 2011 Edition is a ScholarlyEditions™ eBook that delivers timely, authoritative, and comprehensive information about Clinical Medicine Research and Practice. The editors have built Issues in Clinical Medicine Research and Practice: 2011 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Clinical Medicine Research and Practice 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 Clinical Medicine Research and Practice: 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/.

Post-Authorization Safety Studies of Medicinal Products

Post-Authorization Safety Studies of Medicinal Products
The PASS Book

by Ayad K. Ali,Abraham G. Hartzema

  • Publisher : Academic Press
  • Release : 2018-06-27
  • Pages : 362
  • ISBN : 0128092084
  • Language : En, Es, Fr & De
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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

Healthcare and Big Data Management

Healthcare and Big Data Management
A Book

by Bairong Shen

  • Publisher : Springer
  • Release : 2017-10-20
  • Pages : 164
  • ISBN : 981106041X
  • Language : En, Es, Fr & De
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The book addresses the interplay of healthcare and big data management. Thanks to major advances in big data technologies and precision medicine, healthcare is now becoming the new frontier for both scientific research and economic development. This volume covers a range of aspects, including: big data management for healthcare; physiological and gut microbiota – data collection and analysis; big data standardization and ontology; and personal data privacy and systems level modeling in the healthcare context. The book offers a valuable resource for biomedical informaticians, clinicians, health practitioners and researchers alike.

Process Improvement in Heart Failure, An Issue of Heart Failure Clinics EBK

Process Improvement in Heart Failure, An Issue of Heart Failure Clinics EBK
A Book

by Clyde Yancy,Kannan Mutharasan

  • Publisher : Elsevier Health Sciences
  • Release : 2020-09-25
  • Pages : 352
  • ISBN : 0323755534
  • Language : En, Es, Fr & De
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This issue of Heart Failure Clinics, guest edited by Drs. Clyde W. Yancy and R. Kannan Mutharasan, will cover Process Improvement in Heart Failure. This issue is one of four issues selected each year by our series consulting editor, Dr. Eduardo Bossone. Topics discussed in this issue will include: Approaching Process Improvement, Identifying Heart Failure Patients, Predicting High-risk Patients and High-Risk Outcomes in Heart Failure, Selecting the Correct Target for Improvement in Heart Failure Care and Improving Adherence, Empowering Patients Living with Heart Failure with Social Media and Technology, Transitioning Heart Failure Patients to Outpatient Care, Innovating Outpatient Processes of Care and Anticipating Complex Care Algorithms, Addressing Co-morbidities in Heart Failure, Systematizing Heart Failure Population Health, Defragmenting Heart Failure Care, and Adapting to the Payment Landscape.

Encyclopedia of Pharmacy Practice and Clinical Pharmacy

Encyclopedia of Pharmacy Practice and Clinical Pharmacy
A Book

by Anonim

  • Publisher : Academic Press
  • Release : 2019-06-28
  • Pages : 2358
  • ISBN : 0128127368
  • Language : En, Es, Fr & De
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Encyclopedia of Pharmacy Practice and Clinical Pharmacy covers definitions, concepts, methods, theories and applications of clinical pharmacy and pharmacy practice. It highlights why and how this field has a significant impact on healthcare. The work brings baseline knowledge, along with the latest, most cutting-edge research. In addition, new treatments, algorithms, standard treatment guidelines, and pharmacotherapies regarding diseases and disorders are also covered. The book's main focus lies on the pharmacy practice side, covering pharmacy practice research, pharmacovigilance, pharmacoeconomics, social and administrative pharmacy, public health pharmacy, pharmaceutical systems research, the future of pharmacy, and new interventional models of pharmaceutical care. By providing concise expositions on a broad range of topics, this book is an excellent resource for those seeking information beyond their specific areas of expertise. This outstanding reference is essential for anyone involved in the study of pharmacy practice. Provides a ‘one-stop’ resource for access to information written by world-leading scholars in the field Meticulously organized, with articles split into three clear sections, it is the ideal resource for students, researchers and professionals to find relevant information Contains concise and accessible chapters that are ideal as an authoritative introduction for non-specialists and readers from the undergraduate level upwards Includes multimedia options, such as hyperlinked references and further readings, cross-references and videos