rdf-syntax-grammar
mods:
  schema location: http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
  title info:
    title: Post-authorization safety studies of medicinal products
    sub title: the PASS book
  name:
    name part: Ali, Ayad K.
    role:
      role term: editor.
  name:
    name part: Hartzema, Abraham G.
    role:
      role term: editor.
  name:
    name part: ScienceDirect (Online service)
  type of resource: text
  genre: bibliography
  genre: Electronic books.
  genre: Internet Resources.
  origin info:
    place:
      place term: enk
    date issued: 2018
    issuance: monographic
  language:
    language term: eng
  physical description:
    form: remote
    extent: 1 online resource
  abstract: 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.
  table of 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
  table of contents: 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
  table of contents: 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
  note: edited by Ayad K. Ali, Abraham G. Hartzema.
  note: Includes index.
  note: Includes bibliographical references and index.
  subject:
    topic: Drugs
    topic: Testing
  subject:
    topic: Drug monitoring
  subject:
    topic: Risk management
  subject:
    topic: Drug Evaluation
  subject:
    topic: Product Surveillance, Postmarketing
  subject:
    topic: Risk Management
  subject:
    topic: Médicaments
    topic: Essais cliniques
  subject:
    topic: Pharmacovigilance
  subject:
    topic: Gestion du risque
  subject:
    topic: risk management
  subject:
    topic: MEDICAL
    topic: Pharmacology
  subject:
    topic: Risk management
  subject:
    topic: Drug monitoring
  subject:
    topic: Drugs
    topic: Testing
  classification: RM301.9
  classification: 615.7/040287
  classification: 2018 H-178
  classification: QV 771
  related item:
    title info:
      title: Post-authorization safety studies of medicinal products
    origin info:
      publisher: London, United Kingdom : Academic Press, an imprint of Elsevier, 2018
    identifier: (OCoLC)1011519169
  identifier: 9780128092088
  identifier: 0128092084
  identifier: 9780128092170
  identifier: 0128092173
  identifier: 9780128092088 Ingram Content Group
  identifier: http://proxy.library.tamu.edu/login
  record info:
    record content source: N$T
    record creation date: 180618
    record change date: 20260327153425.2
    record identifier: in00005763354
    language of cataloging:
      language term: eng