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Titlebook: Evidence-Based Pharmacovigilance; Clinical and Quantit Andrew Bate Book 2018 Springer Science+Business Media, LLC, part of Springer Nature

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书目名称Evidence-Based Pharmacovigilance
副标题Clinical and Quantit
编辑Andrew Bate
视频video
概述Provides an array of methods that strive to ever more effectively protect patients from medicine-related harm.Covers both clinical and quantitative aspects of Pharmacovigilance.Explores how areas in t
丛书名称Methods in Pharmacology and Toxicology
图书封面Titlebook: Evidence-Based Pharmacovigilance; Clinical and Quantit Andrew Bate Book 2018 Springer Science+Business Media, LLC, part of Springer Nature
描述This book examines insights into the latest thinking and core concepts in areas of key methodological endeavor in Pharmacovigilance (PV), which strives to ever more effectively protect patients from harm caused by the medicines they need. Each book chapter tends to have a clear quantitative or clinical slant and an aim to provide an overview of methodological insights within a specific topic, while also providing a perspective on how the area is anticipated to develop in the future. Quantitative chapters focus more on statistical and epidemiological strategies and the thinking that underpins core developments in Pharmacovigilance, whereas clinical chapters focus on clinical methods for detecting hypotheses for and determining side effects of medicinal products as well as misdiagnosis pitfalls. Examples of areas of importance include signal detection, risk management, and risk benefit assessment..Vital and authoritative, .Evidence-Based Pharmacovigilance: Clinical and Quantitative Aspects. aims to provide readers with a sense of the advances that have occurred in pharmacovigilance methods and approaches, as well as inspiration and motivation to advance the field of pharmacovigilance
出版日期Book 2018
关键词Medicinal products; Risk assessment; PV research; Safety in medication; Pharmaceutical sciences
版次1
doihttps://doi.org/10.1007/978-1-4939-8818-1
isbn_ebook978-1-4939-8818-1Series ISSN 1557-2153 Series E-ISSN 1940-6053
issn_series 1557-2153
copyrightSpringer Science+Business Media, LLC, part of Springer Nature 2018
The information of publication is updating

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Pediatric Pharmacovigilance: Current Practice and Future Perspectives,ype, suspected medicines, age and gender of the child, and type of reporter. Secondly to review experiences with the EU pediatric regulation and its impact on the conduction of pediatric clinical trials in Europe. This literature review showed that occurrence of ADRs in pediatric populations differs
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Detecting Safety Issues in Clinical Trials, is collected and often undergoes a detailed review by the sponsor. Detecting safety issues during a trial has revolved primarily around the Data Safety Monitoring Board (DSMB) who review unblinded summarized data and case reports. Final trial publications typically contain descriptive analyses on t
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Developments and Future Directions of Prescription-Based Observational Cohort Pharmacovigilance,development as compared to during use within routine clinical practice, post marketing. Changes in pharmacovigilance regulations and legislation have given greater weight to the importance of post-marketing observational research and understanding more regarding natural variation in patients and the
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Electronic Health Record, Transactional Insurance Claims, and Distributed Databases in Pharmacovigith record databases, traditional insurance claims databases, and distributed data networks. Strengths, weaknesses, considerations, and examples are presented. Finally, the chapter covers the concepts and challenges of data linkage across resources and offers several future perspectives on data avail
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Patient Reported Outcomes in Pharmacovigilance,first hand from those who have experienced the adverse drug reactions. These experiences are richer in context and information of the impact of an ADR as compared to information from healthcare professionals. New technologies (i.e., Internet) have made the collection of patient reported information
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Evidence-Based Pharmacovigilance for Medicines Used in Public Health Programs in Africa,me for International Drug Monitoring having increased from just 5 in the year 2000 to 35 in 2017. However, published information indicates that Africa’s contribution of individual case safety reports (ICSRs) to the WHO ICSR database (VigiBase) is paltry currently standing at less than 1% of the >14
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