Drug Safety Data How To Analyze Summarize And Interpret To Determine Risk
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Drug Safety Data How To Analyze Summarize And Interpret To Determine Risk
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Author : Michael J. Klepper
language : en
Publisher: Jones & Bartlett Publishers
Release Date : 2010-09-15
Drug Safety Data How To Analyze Summarize And Interpret To Determine Risk written by Michael J. Klepper and has been published by Jones & Bartlett Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-09-15 with Medical categories.
Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk was selected for The First Clinical Research Bookshelf - Essential reading for clinical research professionals by the Journal of Clinical Research Best Practices. Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides drug safety/pharmacovogilance professionals, pharmaceutical and clinical research scientists, statisticians, programmers, medical writers, and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data. The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an invaluable reference for pre- and post-marketing risk assessment. With decades of pharmaceutical research and drug safety expertise, authors Dr. Klepper and Dr. Cobert discuss how quality planning, safety training, and data standardization result in significant cost, time, and resource savings. Through illustrative, step-by-step instruction, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is the definitive guide to drug safety data analysis and reporting. Key features include: * Step-by-step instruction on how to analyze, summarize and interpret safety data for mandatory governmental safety reports * Pragmatic tips...and mistakes to avoid * Simple explanations of what safety data are collected, and what the data mean * Practical approaches to determining a drug effect and understanding its clinical significance * Guidance for determining risk throughout the lifecycle of a drug, biologic or nutraceutical * Examples of user-friendly data displays that enhance safety signal identification * Ways to improve data quality and reduce the time, resources and costs involved in mandatory safety reporting * Relevant material for the required training of drug safety/pharmacovigilance professionals * SPECIAL FEATURE: Actual examples of an Integrated Analysis of Safety (IAS) -used in the preparation of the Integrated Summary of Safety (ISS) and the Summary of Clinical Safety (SCS) reports -, and the Periodic Safety Update Report (PSUR)
Drug Safety Data
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Author : Michael J. Klepper
language : en
Publisher:
Release Date : 2011
Drug Safety Data written by Michael J. Klepper and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011 with Health risk assessment categories.
Pharmacovigilance E Book
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Author : Thao Doan
language : en
Publisher: Elsevier Health Sciences
Release Date : 2024-11-20
Pharmacovigilance E Book written by Thao Doan and has been published by Elsevier Health Sciences this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-11-20 with Medical categories.
Written by multidisciplinary experts in the fields of pharmaceutical and patient safety, Pharmacovigilance: A Practical Approach, Second Edition, provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. From cover to cover, this concise resource offers essential information for physicians and other health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance. - Presents vital, easy-to-read, cutting-edge information on patient safety, the pharmacology regulatory landscape, and the current and future use of digital technologies. - Provides up-to-date coverage of hot topics in the field, including pharmacodynamic and safety precision medicine, immunogenicity, vaccine hesitancy and safety, genetic toxicology, and adverse events. - Contains new chapters on pre-clinical safety assessment, pharmacogenetics, first-in human trials, product aggregate safety assessment, data monitoring committees, and more. - Offers new and expanded coverage of pharmacovigilance in early pre-clinical drug development through post-marketing surveillance, as well as a blueprint for training future pharmacovigilance professionals. - Includes real-world case studies to ensure content is relevant and applicable to everyday practice. - Discusses a range of topics across disciplines and how they relate to pharmacovigilance, including behavioral science, patient perspectives, and risk communication. - Any additional digital ancillary content may publish up to 6 weeks following the publication date.
Pharmacovigilance
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Author : Mr. Rohit Manglik
language : en
Publisher: EduGorilla Publication
Release Date : 2024-04-06
Pharmacovigilance written by Mr. Rohit Manglik and has been published by EduGorilla Publication this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-04-06 with Medical categories.
EduGorilla Publication is a trusted name in the education sector, committed to empowering learners with high-quality study materials and resources. Specializing in competitive exams and academic support, EduGorilla provides comprehensive and well-structured content tailored to meet the needs of students across various streams and levels.
Pharmacovigilance Essentials
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Author : Mukesh Nandave
language : en
Publisher: Springer Nature
Release Date : 2024-04-03
Pharmacovigilance Essentials written by Mukesh Nandave and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-04-03 with Medical categories.
The book explores the field of pharmacovigilance, its historical context, along with its critical role in ensuring the safety of medications across the world. From its foundational principles to cutting-edge advancements and future challenges, this book provides a thorough understanding of the field's intricacies. The book begins by establishing the fundamentals of pharmacovigilance, emphasizing its significance in monitoring, detecting, assessing, and preventing adverse drug reactions (ADRs) that occur during the use of medications. Delving into the history of pharmacovigilance and regulatory actions, the book traces the evolution of the field, highlighting significant milestones and the establishment of regulatory frameworks that govern medication safety. It explores the pivotal role of regulatory authorities in developing guidelines, regulations, and policies to safeguard public health. A significant aspect covered in the book is the processing of ADRs, providing insights into the steps involved in handling and evaluating ADR reports. The book also addresses specialized areas within pharmacovigilance, including vaccine safety surveillance, herbovigilance (monitoring the safety of herbal medicines), materiovigilance (monitoring the safety of medical devices), and hemovigilance (ensuring the safety of blood products). Additionally, the book explores the role of pharmacogenetics in pharmacovigilance, highlighting how genetic factors influence individual responses to medications and how this knowledge can be integrated into safety monitoring and risk assessment. This book also covers databases used in pharmacovigilance across the globe, aggregate reporting and pharmacovigilance systems in EU and non-EU countries, and the role of artificial intelligence. Finally, it emphasizes the need for continuous improvement, vigilance, and proactive measures to adapt to the changing healthcare landscape and address emerging safety concerns. The book serves as acomprehensive guide for healthcare professionals, researchers, regulators, and policymakers involved in pharmacovigilance.
Neuropsychopharmacology
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Author : Jahangir Moini
language : en
Publisher: Elsevier
Release Date : 2023-05-10
Neuropsychopharmacology written by Jahangir Moini and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-05-10 with Medical categories.
Neuropsychopharmacology reviews the principles of pharmacology with a focus on the central nervous system and autonomic nervous system. Beyond autonomic and central nervous system pharmacology, this volume uniquely discusses psychiatric disorders and the pharmacological interventions that are available for conditions including depression, schizophrenia and anxiety disorders. With a focus on these specific body systems, readers will see end-of-chapter questions that offer real-world case studies, as well as multiple-choice questions for further learning. Beneficial features and content also include two extensive examination tests, which each contain 100 questions for better learning or to be used in teaching, and a glossary. Helpful appendices cover high-alert medications and toxicology effects on the nervous system. Each chapter will contain classifications of medications, pharmacokinetics, mechanism of action, clinical indications and toxicities. - Describes pharmacology principles pertaining to the central and autonomic nervous system - Identifies pharmacological interventions for psychiatric disorders including current evidence-based interventions for depression, schizophrenia and anxiety disorders - Features chapter outlines, end-of-chapter questions, real-world case studies and examinations for deeper learning or teaching
Vigilance Unleashed
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Author : Dr. Akash Sharma, Vriti Gamta, Gaurav Luthra
language : en
Publisher: Notion Press
Release Date : 2023-09-13
Vigilance Unleashed written by Dr. Akash Sharma, Vriti Gamta, Gaurav Luthra and has been published by Notion Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-09-13 with Medical categories.
Discover the world of pharmacovigilance, where patient safety takes center stage. In "Vigilance Unleashed: From Adverse Events to Patient Protection," we delve into the science and practices that safeguard patients from medication and medical devices' risks. Unravel the historical background, regulatory frameworks, and international collaborations that shape pharmacovigilance practices. From identifying adverse drug reactions to embracing emerging technologies and patient-centered approaches, this comprehensive guide equips readers with essential knowledge to navigate the dynamic landscape of pharmacovigilance confidently. Join us on this journey to champion patient safety and unleash the power of vigilance in healthcare.
Design And Analysis Of Clinical Trials
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Author : Shein-Chung Chow
language : en
Publisher: John Wiley & Sons
Release Date : 2013-09-30
Design And Analysis Of Clinical Trials written by Shein-Chung Chow and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-09-30 with Mathematics categories.
Praise for the Second Edition: “...a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite.” —Journal of Clinical Research Best Practices The Third Edition of Design and Analysis of Clinical Trials provides complete, comprehensive, and expanded coverage of recent health treatments and interventions. Featuring a unified presentation, the book provides a well-balanced summary of current regulatory requirements and recently developed statistical methods as well as an overview of the various designs and analyses that are utilized at different stages of clinical research and development. Additional features of this Third Edition include: • New chapters on biomarker development and target clinical trials, adaptive design, trials for evaluating diagnostic devices, statistical methods for translational medicine, and traditional Chinese medicine • A balanced overview of current and emerging clinical issues as well as newly developed statistical methodologies • Practical examples of clinical trials that demonstrate everyday applicability, with illustrations and examples to explain key concepts • New sections on bridging studies and global trials, QT studies, multinational trials, comparative effectiveness trials, and the analysis of QT/QTc prolongation • A complete and balanced presentation of clinical and scientific issues, statistical concepts, and methodologies for bridging clinical and statistical disciplines • An update of each chapter that reflects changes in regulatory requirements for the drug review and approval process and recent developments in statistical design and methodology for clinical research and development Design and Analysis of Clinical Trials, Third Edition continues to be an ideal clinical research reference for academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students.
Cobert S Manual Of Drug Safety And Pharmacovigilance Third Edition
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Author : Barton Cobert
language : en
Publisher: World Scientific
Release Date : 2019-04-09
Cobert S Manual Of Drug Safety And Pharmacovigilance Third Edition written by Barton Cobert and has been published by World Scientific this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-04-09 with Medical categories.
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.Related Link(s)
Evidence Synthesis And Meta Analysis
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Author : Council for International Organizations of Medical Sciences (CIOMS)
language : en
Publisher: Council for International Organizations of Medical Sciences
Release Date : 2016-12-30
Evidence Synthesis And Meta Analysis written by Council for International Organizations of Medical Sciences (CIOMS) and has been published by Council for International Organizations of Medical Sciences this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-12-30 with Medical categories.
At any point in the drug development process, systematic reviews and meta-analysis can provide important information to guide the future path of the development programme and any actions that might be needed in the post-marketing setting. This report gives the rationale for why and when a meta-analysis should be considered, all in the context of regulatory decision-making, and the tasks, data collection, and analyses that need to be carried out to inform those decisions. There is increasing demand by decision-makers in health care, the biopharmaceutical industry, and society at large to have access to the best available evidence on benefits and risks of medicinal products. The best strategy will take an overview of all the evidence and where it is possible and sensible, combine the evidence and summarize the results. For efficacy, the outcomes generally use the same or very similar predefined events for each of the trials to be included. Most regulatory guidance and many Cochrane Collaboration reviews have usually given more attention to assessment of benefits, while issues around combining evidence on harms have not been as well-covered. However, the (inevitably) unplanned nature of the data on safety makes the process more difficult. Combining evidence on adverse events (AEs), where these were not the focus of the original studies, is more challenging than combining evidence on pre-specified benefits. This focus on AEs represents the main contribution of the current CIOMS X report. The goal of the CIOMS X report is to provide principles on appropriate application of meta-analysis in assessing safety of pharmaceutical products to inform regulatory decision-making. This report is about meta-analysis in this narrow area, but the present report should also provide conceptually helpful points to consider for a wider range of applications, such as vaccines, medical devices, veterinary medicines or even products that are combinations of medicinal products and medical devices. Although some of the content of this report describes highly technical statistical concepts and methods (in particular Chapter 4), the ambition of the working group has been to make it comprehensible to non-statisticians for its use in clinical epidemiology and regulatory science. To that end, Chapters 3 and 4, which contain the main technical statistical aspects of the appropriate design, analysis and reporting of a meta-analysis of safety data are followed by Chapter 5 with a thought process for evaluating the findings of a meta-analysis and how to communicate these.