药物警戒基础：进展、挑战与全球视角

English | 2024 | ISBN-10: 9819989485 | 505 pages| Epub PDF (True) | 88 MB

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.

这本书探讨了药物警戒领域的现状，追溯其历史背景，并强调它在全球确保药物安全中的关键作用。从基本原则到前沿进展以及未来的挑战，本书详尽地介绍了该领域的复杂性。书的开始部分确立了药物警戒的基本原则，强调其在监测、检测、评估和预防药物使用过程中发生的不良药物反应（ADR）方面的重要性。书中深入探讨了药物警戒的历史及其监管行动，追溯了这一领域的发展历程，并突显出一些重要的里程碑以及规范药品安全所建立的监管框架。本书还讨论了监管机构在制定指导原则、法规和政策以保障公共卫生方面的关键作用。书中的一个显著内容是不良反应（ADR）的处理过程，提供了处理和评估报告步骤的见解。此外，这本书也探讨了药物警戒领域的专项领域，包括疫苗安全监测、草本药品监控（herbovigilance）、医疗器械监控（materiovigilance）以及血液产品监控（hemovigilance）。另外，本书还探讨了药物警戒中的药理遗传学的作用，强调遗传因素如何影响个体对药物的反应，以及这种知识如何整合到安全监测和风险评估中。此外，这本书还涵盖了全球范围内用于药物警戒的各种数据库、欧盟及非欧盟国家的汇总报告与药物警戒系统，以及人工智能的角色。 最后，它强调了持续改进、警惕性和主动措施以适应不断变化的医疗保健环境并应对新兴的安全问题的重要性。这本书为参与药物警戒工作的医护人员、研究人员、监管者和政策制定者提供了一个全面指南。

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