Title Post-authorization safety studies of medicinal products : the PASS book / edited by Ayad K. Ali, Abraham G. Hartzema

Published London, United Kingdom : Academic Press, an imprint of Elsevier, 2018

Click on the following:
ScienceDirect eBooks

Copies

Description 1 online resource Contents Intro; Title page; Table of Contents; Copyright; List of Contributors; Foreword; Chapter 1. Introduction; Risk Management and Benefit-Risk Evaluation; Transparency; About This Book; Chapter 2. Risk Management Process; Chapter 2.1. Risk Assessment; Chapter 2.2. Risk Minimization; Chapter 3. Data Sources for Post-Authorization Safety Studies; Chapter 3.1. Health Insurance Administrative Claims; Chapter 3.2. Electronic Medical Records; Chapter 3.3. Registries; Chapter 3.4. Big Data; Chapter 3.5. Social Media; Chapter 4. Study Designs for Post-Authorization Safety Studies Chapter 4.1. Drug Utilization and Prescription-Event Monitoring StudiesChapter 4.2. Self-Controlled Studies; Chapter 4.3. Cohort and Nested Case-Control Studies; Chapter 4.4. Enriched Studies; Chapter 4.5. Prospective Studies; Chapter 5. Analytical Approaches for Post-Authorization Safety Studies; Chapter 5.1. Exposure Propensity Scores; Chapter 5.2. Disease Risk Scores; Chapter 5.3. Instrumental Variables; Chapter 5.4. Data Analytic Platforms; Chapter 5.5. Proactive Safety Surveillance; Chapter 6. Benefit-Risk Evaluation; Chapter 6.1. Benefit-Risk Evaluation Frameworks Chapter 6.2. Post-Authorization Effectiveness StudiesChapter 7. Post-Authorization Safety Studies for Specialty Products; Chapter 7.1. Post-Authorization Safety Studies for Biosimilars and Interchangeable Biologic Products; Chapter 7.2. Post-Authorization Safety Studies for Medical Devices and Combination Products; Chapter 7.3. Post-Authorization Safety Studies for Vaccines; Chapter 8. The European Union Post-Authorization Study Register; Disclaimer/Acknowledgments; Introduction; Index 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 Notes Includes index Bibliography Includes bibliographical references and index Notes Online resource; title from PDF title page (ScienceDirect, viewed June 20, 2018) Subject Drugs -- Testing. Drug monitoring. Risk management. Drug Evaluation Product Surveillance, Postmarketing Risk Management risk management. MEDICAL -- Pharmacology. Risk management Drug monitoring Drugs -- Testing Form Electronic book Author Ali, Ayad K., editor Hartzema, Abraham G., editor ISBN 9780128092088 0128092084

  Permalink