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Pharmacoepidemiology and Pharmacovigilance "Synergistic Tools to Better Investigate Drug Safety"

  • EDITOR Academic Press Ltd.
  • NIVEL Profesional
  • IDIOMACastellano
  • ISBN 978-0-12-816183-8
  • EAN 9780128161838
  • Colección -
  • Número -
  • Encuadernado Tapa Dura
  • Páginas 250
  • Largo -
  • Ancho -
  • Peso -
  • Fecha 17-10-2018
  • Número 1
  • Año 2018
Pharmacoepidemiology and Pharmacovigilance: Synergistic Tools to Better Investigate Drug Safety examines the role of pharmacoepidemiologic studies in drug development and its use as a prevention tool in pharmacovigilance activities. The book introduces the various epidemiologic tools and study designs commonly used for the surveillance of drug-related adverse effects and reviews the strengths and weaknesses of each. Criticisms surrounding pharmacoepidemiologic research and issues that often interfere or complicate the conduct and interpretation of these studies are also explored. Case studies illustrate the passive and active surveillance of adverse drug reactions in clinical situations, covering important pharmacoepidemiologic concepts like health risk management and safety.

The book helps pharmaceutical industry groups engaged in drug safety, clinical investigators, medical evaluators and those seeking regulatory approval enhance the safety of the drug development process for all patient populations.
Key Features

Describes the main prevention tools for the passive and active surveillance of adverse effects associated with drugs
Provides examples of diseases in various contexts related to clinical studies and the analysis of adverse drug reactions
Offers case studies that illustrate real-life clinical situations
Discusses important concepts related to pharmacoepidemiology and pharmacovigilance


Pharmaceutical industry personnel (especially those working in drug safety), clinical investigators, medical evaluators, those seeking regulatory approval. Students and professors in Clinical Pharmacology, Epidemiology, and Pharmacovigilance

Table of Contents

Chapter 1: Introduction

This chapter will provide a brief introduction on Pharmaco-epidemiology and outline the objectives for this text

Chapter 2: The role of pharmacoepidemiologic research in drug development

This chapter outlines how the discipline of Pharmaco-epidemiology fits into and can be applied within the drug development process

Chapter 3: Pharmaco-epidemiology in the prevention of adverse drug reactions.

This chapter includes the major content of the book which includes a brief overview of the main prevention tools for passive and active surveillance of adverse effects associated with drugs. This chapter includes the following sub-sections:

- Passive surveillance methods:

Spontaneous reporting of adverse drug reactions, case series reports, Periodic Safety Update Reports, Periodic Benefit Risk Evaluation Reports, Risk Management Plan, Development Safety Update Reports)

- Active surveillance methods:

Patient registries

- The necessity of Pharmaco-epidemiology:

Outlining the need for Pharmaco-epidemiology in the drug development process

- Tools for Safety Research in Pharmacoepidemiology Qualitative and quantitative detection of signals

- Observational study designs used in pharmacoepidemiology

Research; prospective cohort study; retrospective cohort study; case-control study; cross-sectional study; nested case-control study, case-cohort study, self-control study

- Bias and confounding factors

Selection bias; information bias; confounding factors

-Critical appraisal in pharmaco-epidemiology research

- Data sources for Pharmacoepidemiology research

- Experimental study designs

Large simple trial; N-of-1 trial

- Literature reviews; Systematic reviews; Meta-analyses

Chapter 4: Case Studies

This chapter illustrates, in a more concrete way, the information provided in the first sections of this book. Each case study illustrates a ‘real-life’ scenario and is composed of questions and answers based on appropriate clinical situations in order to provide all the necessary tools to all the partners involved in the passive and active surveillance of adverse drug reactions. These case studies also discuss important concepts related to pharmaco-epidemiology including Health Risk Management and safety measures; disproportionality analysis in spontaneous case reporting; and the use of superiority trials to establish drug safety and others

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