Post-authorization safety studies of medicinal products : the PASS book /

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...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Ali, Ayad K. (Editor ), Hartzema, Abraham G. (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: London, United Kingdom : Academic Press, an imprint of Elsevier, 2018.
Temas:
Drugs > Testing.
Drug monitoring.
Risk management.
Drug Evaluation
Product Surveillance, Postmarketing
Risk Management
M�edicaments > Essais cliniques.
Pharmacovigilance.
Gestion du risque.
risk management.
MEDICAL > Pharmacology.
Risk management
Drug monitoring
Drugs > Testing
Internet Resources.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 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

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