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Pharmacoepidemiology and Pharmacovigilance

Pharmacoepidemiology and Pharmacovigilance
  • Author : Sabrina Nour,Gilles Plourde
  • Publisher :Unknown
  • Release Date :2018-10-17
  • Total pages :144
  • ISBN : 9780128163818
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Summary : Pharmacoepidemiology and Pharmacovigilance: Synergistic Tools to Better Investigate Drug Safety examines the role of pharmacoepidemiologic studies in drug development and its use as a prevention tool in pharmacovigilance activities. The book introduces the various epidemiologic tools and study designs commonly used for the surveillance of drug-related adverse effects and reviews the strengths and weaknesses of each. Criticisms surrounding pharmacoepidemiologic research and issues that often interfere or complicate the conduct and interpretation of these studies are also explored. Case studies illustrate the passive and active surveillance of adverse drug reactions in clinical situations, covering important pharmacoepidemiologic concepts like health risk management and safety. The book helps pharmaceutical industry groups engaged in drug safety, clinical investigators, medical evaluators and those seeking regulatory approval enhance the safety of the drug development process for all patient populations. Describes the main prevention tools for the passive and active surveillance of adverse effects associated with drugs Provides examples of diseases in various contexts related to clinical studies and the analysis of adverse drug reactions Offers case studies that illustrate real-life clinical situations Discusses important concepts related to pharmacoepidemiology and pharmacovigilance

Understanding Pharmacoepidemiology

Understanding Pharmacoepidemiology
  • Author : Yi Yang,Donna West-Strum
  • Publisher :Unknown
  • Release Date :2010-12-31
  • Total pages :208
  • ISBN : 0071766677
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Summary : A concise introduction to the study of medication utilization and safety in large populations of people Understanding Pharmacoepidemiology is a clear, engagingly written roadmap to mastering the important concepts and methods of pharmacoepidemiology. It explains what pharmacoepidemiology is, how pharmacoepidemiology studies are conducted, and how to interpret findings. You will learn the importance of pharmacoepidemiology, basic terminology used in research, and the data sources, study designs, and statistical analyses employed in pharmacoepidemiology research. Upon completing Understanding Pharmacoepidemiology you will have a better understanding of how to evaluate the associations between medication utilization and outcomes. Each chapter includes these valuable learning aids: A list of learning objectives Case studies or examples Discussion questions Tables and Figures You will also find a glossary of important words and terms. The content you need to understand the concepts and methods of pharmacoepidemiology: Introduction to Pharmacoepidemiology: Principles of Epidemiology Applied to the Study of Medication Use, Study Designs in Pharmacoepidemiology: Using Secondary Data in Pharmacoepidemiology; Biostatistics and Pharmacoepidemiology: Other Methodological Issues; Evaluation of Pharmacoepidemiology Literature; Medication Utilization Patterns; Medication Safety and Pharmacovigilance; and FDA Perspectives on Post-market Drug Safety.

Textbook of Pharmacoepidemiology

Textbook of Pharmacoepidemiology
  • Author : Brian L. Strom,Stephen E. Kimmel
  • Publisher :Unknown
  • Release Date :2013-05-13
  • Total pages :520
  • ISBN : 9781118708002
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Summary : The Textbook of Pharmacoepidemiology provides a streamlined text for evaluating the safety and effectiveness of medicines. It includes a brief introduction to pharmacoepidemiology as well as sections on data sources, methodology and applications. Each chapter includes key points, case studies and essential references. One-step resource to gain understanding of the subject of pharmacoepidemiology at an affordable price Gives a perspective on the subject from academia, pharmaceutical industry and regulatory agencies Designed for students with basic knowledge of epidemiology and public health Includes many case studies to illustrate pharmacoepidemiology in real clinical setting

Pharmacovigilance and Pharmacoepidemiology

Pharmacovigilance and Pharmacoepidemiology
  • Author : Ravi Humbarwadi
  • Publisher :Unknown
  • Release Date :2014-08-05
  • Total pages :208
  • ISBN : 1500738115
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Summary : Pharmacovigilance and Pharmacoepidemiology. MedDRA Coding, ICSR, Types of reports, Causality, SUSAR, EMEA, GVP, Eudravigilance, FDA, MedWATCH, Signal Detection, List of IME, and Narrative Writing. NIS (Non interventional study), PASS (Post authorisation safety study). Role of epidemiology in RMP (Risk Management Plan), CER (Competitive Efectiveness research), Post Marketing risk profile and Post marketing Signals. Cohort, Case control and study designs. EuPAS, Good Pharmacoepidemiology Practice (GPP), STROBE, EnCePP, Protocol and Guidelines.

An Introduction to Pharmacovigilance

An Introduction to Pharmacovigilance
  • Author : Patrick Waller,Mira Harrison-Woolrych
  • Publisher :Unknown
  • Release Date :2017-05-01
  • Total pages :192
  • ISBN : 9781119289746
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Summary : 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.

Mann's Pharmacovigilance

Mann's Pharmacovigilance
  • Author : Elizabeth B. Andrews,Nicholas Moore
  • Publisher :Unknown
  • Release Date :2014-03-24
  • Total pages :872
  • ISBN : 9781118820148
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Summary : 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.

Cobert's Manual of Drug Safety and Pharmacovigilance

Cobert's Manual of Drug Safety and Pharmacovigilance
  • Author : Barton Cobert
  • Publisher :Unknown
  • Release Date :2011-04-01
  • Total pages :407
  • ISBN : 9780763791599
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Summary : Rev. ed. of: Manual of drug safety and pharmacovigilance / Barton L. Cobert. c2007.

Post-Authorization Safety Studies of Medicinal Products

Post-Authorization Safety Studies of Medicinal Products
  • Author : Ayad K. Ali,Abraham G. Hartzema
  • Publisher :Unknown
  • Release Date :2018-06-27
  • Total pages :362
  • ISBN : 9780128092088
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Summary : 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

Pharmacovigilance- An Industry Perspective

Pharmacovigilance- An Industry Perspective
  • Author : Deepa Arora
  • Publisher :Unknown
  • Release Date :2021
  • Total pages :229
  • ISBN : 9788192335407
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Summary :

Pharmacovigilance

Pharmacovigilance
  • Author : I. Ralph Edwards,Marie Lindquist
  • Publisher :Unknown
  • Release Date :2016-10-27
  • Total pages :205
  • ISBN : 9783319404004
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Summary : Written by experienced authors, this book offers expert personal views on what the current problems in pharmacovigilance are and how they should be solved. This book stems from thoughts and ideas discussed in a series of meetings of the International Society of Pharmacovigilance (ISoP), where concerns were raised that the current pharmacovigilance system is not delivering optimally to improve therapeutics in clinical practice. Pharmacovigilance of the future must be an active and integral part of health care delivery, and focus more on science and practices that support health professionals and patients in day-to-day care situations. To achieve this, a dynamic and sustainable development of vigilance must take precedence over the current excessive preoccupations with data processing and regulations; all aspects of medicines use and their effects need to be considered; and all stakeholders must be involved and engaged in an open and constructive debate. The work is essential reading for anyone who has an interest in safer use of medicines. It is intended to be equally challenging and rewarding, and sets out to stimulate a continuous debate on how pharmacovigilance can better meet the needs of health professionals and patients to achieve the aim of wise therapeutic decision making.

Drug Safety

Drug Safety
  • Author : Ravi Humbarwadi
  • Publisher :Unknown
  • Release Date :2015-04-16
  • Total pages :206
  • ISBN : 1511686782
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Summary : Pharmacovigilance: The principles and practice of pharmacovigilance. Case processing guidelines and CIOMS format. With examples of MedDRA coding, regulatory process including EMEA, FDA and GVP 2012. List of IME (useful in day to day operations to help decide serious vs non-serious cases). Pharmacoepidemiology : Study Designs - Types designs and their use in different situations. Comprehensive description of NIS. Protocol, STROBE, ENCePP and Good pharmacoepidemiology Practices.Pharmacovigilance Database : Graphic Description. Field by Filed and Module by Module. Includes Overview of Oracle ARGUS. A MEGA BOOK OF DRUG SAFETY. Clear Any Interview. Get That Better Job.

Pharmacoepidemiology

Pharmacoepidemiology
  • Author : Brian L. Strom
  • Publisher :Unknown
  • Release Date :2006-01-04
  • Total pages :910
  • ISBN : 9780470866832
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Summary : The fourth edition of Pharmacoepidemiology is an outstanding and fully comprehensive textbook, which will be an essential resource for all interested in the field—in academia, in regulatory agencies, in industry and in the law. Brian Strom’s classic textbook continues both to reflect the increased maturation of pharmacoepedemiology and to help shape it’s direction. Reviews of previous editions of his celebrated textbook include: "The book is essential reading for anyone interested in pharmacoepidemiology." INTERNATIONAL JOURNAL OF EPIDEMIOLOGY “...an excellent textbook and a comprehensive reference which belongs in the library of every pharmaceutical manufacturer and regulator." EUROPEAN JOURNAL OF PUBLIC HEALTH

Pharmacovigilance

Pharmacovigilance
  • Author : Ronald D. Mann,Elizabeth B. Andrews
  • Publisher :Unknown
  • Release Date :2003-01-24
  • Total pages :582
  • ISBN : 9780470852972
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Summary : Interest in the field of pharmacovigilance has grown rapidly in recent years with the possible toxicity of a drug becoming as much a focus of clinical trials as its benefits. This key text is a definitive resource for professionals working within pharmacovigilance. Written by leading professionals in the field, its clear structure, covers all the important aspects of the subject including:- * Legal aspects * Drug regulatory requirements * Methods of signal generation * Reporting schemes * Pharmacovigilance in selected system-organ classes * Future directions This comprehensive book should be in all pharmacovigilance departments, regional pharmacovigilance centres and regulatory authorities. It is an unparalleled source of information and reference for all researchers in pharmacovigilance, pharmaceutical practice and medicine.

Clinical Pharmacy Education, Practice and Research

Clinical Pharmacy Education, Practice and Research
  • Author : Dixon Thomas
  • Publisher :Unknown
  • Release Date :2018-11-23
  • Total pages :540
  • ISBN : 9780128142776
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Summary : Clinical Pharmacy Education, Practice and Research offers readers a solid foundation in clinical pharmacy and related sciences through contributions by 83 leading experts in the field from 25 countries. This book stresses educational approaches that empower pharmacists with patient care and research competencies. The learning objectives and writing style of the book focus on clarifying the concepts comprehensively for a pharmacist, from regular patient counseling to pharmacogenomics practice. It covers all interesting topics a pharmacist should know. This book serves as a basis to standardize and coordinate learning to practice, explaining basics and using self-learning strategies through online resources or other advanced texts. With an educational approach, it guides pharmacy students and pharmacists to learn quickly and apply. Clinical Pharmacy Education, Practice and Research provides an essential foundation for pharmacy students and pharmacists globally. Covers the core information needed for pharmacy practice courses Includes multiple case studies and practical situations with 70% focused on practical clinical pharmacology knowledge Designed for educational settings, but also useful as a refresher for advanced students and researchers

Developing Drug Products in an Aging Society

Developing Drug Products in an Aging Society
  • Author : Sven Stegemann
  • Publisher :Unknown
  • Release Date :2016-10-20
  • Total pages :771
  • ISBN : 9783319430997
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Summary : This book aims to address the major aspects of future drug product development and therapy for older adults, giving practical guidance for the rational product and clinical development and prescribing of drug products to this ever growing segment of the population. With authors coming from key “aging” markets such as Europe, the USA, China and Japan, the book will provide valuable information for students, scientists, regulators, practitioners, and other healthcare professionals from academia, industry and regulatory bodies.

Encyclopedia of Pharmacy Practice and Clinical Pharmacy

Encyclopedia of Pharmacy Practice and Clinical Pharmacy
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :2019-06-28
  • Total pages :2358
  • ISBN : 9780128127360
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Summary : 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

Practical Drug Safety from A to Z

Practical Drug Safety from A to Z
  • Author : Barton Cobert,Pierre Biron
  • Publisher :Unknown
  • Release Date :2009-10-06
  • Total pages :402
  • ISBN : 9780763745271
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Summary : The Dictionary of Drug Safety and Pharmacovigilance is an alphabetical guide to drug safety monitoring (pharmacovigilance), covering literally, the

Concept Of Pharmacoepidemiology And Pharmacoeconomics

Concept Of Pharmacoepidemiology And Pharmacoeconomics
  • Author : Dr. Aditya Parashar
  • Publisher :Unknown
  • Release Date :2020-09-07
  • Total pages :129
  • ISBN : 9789390362653
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Summary : The book titled “Concept of Pharmacoepidemiology and Pharmacoeconomics” clearing each concept related to pharmacoepidemiology and pharmacoeconomics. The subject is highly dynamic and research-based or in simple it is a subject of methods in clinical pharmacy. As a student clinical pharmacy practitioner, you will find most of the research concept and mind map about it. When I was Doctor of Pharmacy, fifth Year student there is no such related book is available in Indian market whereas some books are available but not on the Pharmacy Council of India syllabus. Also, those books are not appropriate as well as hard to understand. From that time I start thinking to write a book on this particular subject in 2016, even this time we don’t have a suitable book. Finally, I have started writing a book by searching, reading, writing and simplifying the things and completed in 2020. This based on the Pharmacy Council of India prescribed syllabus and with question bank after each chapter. This book also helpful in understanding the methods of pharmacy practice research work. I think this book will helpful for Doctor of Pharmacy, fifth Year student and will understand topics in a more easy way. I am eager to receive valuable feedback and suggestions from students and other readers/ researcher of this textbook. All credit for this book, especially to Dr. Abhiram Rout professor and principal school of Pharmacy, Centurion University, Aayushi Parashar for valuable work.

Drug Utilization Research

Drug Utilization Research
  • Author : Monique Elseviers,Björn Wettermark,Anna Birna Almarsdóttir,Morten Andersen,Ria Benko,Marion Bennie,Irene Eriksson,Brian Godman,Janet Krska,Elisabetta Poluzzi,Kstja Taxis,Vera Vlahovic-Palcevski,Robert Vander Stichele
  • Publisher :Unknown
  • Release Date :2016-05-31
  • Total pages :536
  • ISBN : 9781118949788
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Summary : Drug Utilization Research (DUR) is an eclectic scientific discipline, integrating descriptive and analytical methods for the quantification, understanding and evaluation of the processes of prescribing, dispensing and consumption of medicines and for the testing of interventions to enhance the quality of these processes. The discipline is closely related and linked mainly to the broader field of pharmacoepidemiology, but also to health outcomes research, pharmacovigilance and health economics. Drug Utilization Research is a unique, practical guide to the assessment and evaluation of prescribing practices and to interventions to improve the use of medicines in populations. Edited by an international expert team from the International Society for Pharmacoepidemiology (ISPE), DUR is the only title to cover both the methodology and applications of drug utilization research and covers areas such as health policy, specific populations, therapeutics and adherence.

Drug Epidemiology and Post-Marketing Surveillance

Drug Epidemiology and Post-Marketing Surveillance
  • Author : Brian L. Strom,G.P Velo
  • Publisher :Unknown
  • Release Date :2013-06-29
  • Total pages :172
  • ISBN : 9781489925879
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Summary : This volume is a summary of material presented in the course given in the International School of Phannacology on "Drug Epidemiology and Post-Marketing Surveillance" between September 27 and October 8, 1990, at the "Ettore Majorana Center for Scientific Culture" in Erice, Sicily. The course, which was a NATO Advanced Study Institute, included lectures and workshops presented by experts in the new field of phannacoepidemiology. The material covered includes various approaches to spontaneous reporting of adverse drug reactions, including aggregate approaches, such as those used in France, and detailed analyses of individual reports, such as that done in The Netherlands and in Sweden. Also, included are studies using traditional epidemiology methods. In addition, modern pharmacoepidemiology makes considerable use of automated databases. As such, information is presented on their use as well. Phannacoepidemiology started in hospitals and some of the newest work in the field is returning to the hospital as a site for studies. Material on these topics was presented as well. Finally, selected new methodologic developments were outlined in specific examples presented that were of regulatory and commercial importance. This new field of phannacoepidemiology is exploding in interest internationally. Evidence of this is the increasing development of pharmacoepidemiology programs in industry, medical schools, pharmacy schools, and schools of public health. Also, there is a new International Society ofPhannacoepidemiology. Practitioners in this field tend to specialize in either analyses of spontaneous reporting or the use of formal epidemiologic techniques.

Pharmacovigilance: A Practical Approach

Pharmacovigilance: A Practical Approach
  • Author : Thao Doan,Cheryl Renz,Fabio Lievano,Mondira Bhattacharya,Linda Scarazzini
  • Publisher :Unknown
  • Release Date :2018-07-31
  • Total pages :228
  • ISBN : 9780323581172
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Summary : Written by experts in the field of pharmacovigilance and patient safety, this concise resource provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. Drs. Thao Doan, Fabio Lievano, Mondira Bhattacharya, and Linda Scarazzini provide essential information for health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance.