Pharmacoepidemiology and Pharmacovigilance: Synergistic Tools to Better Investigate Drug Safety

Pharmacoepidemiology and Pharmacovigilance 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. The main criticisms surrounding pharmacoepidemiologic research as well as the issues that often interfere or complicate the conduct and interpretation of these studies are also explored. Case studies of practical clinical scenarios round out the book and illustrate the passive and active surveillance of adverse drug reactions in clinical situations and covers important pharmacoepidemiologic concepts like health risk management and safety measures, disproportionality analysis in spontaneous case reporting, and the use of superiority trials to establish drug safety. Pharmacoepidemiology and Pharmacovigilance aims to help 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 and for the prevention of adverse reactions to pharmaceutical products.

Describes the main prevention tools for passive and active surveillance of adverse effects associated with drugsProvides examples of diseases in various contexts related to clinical studies and the analysis of adverse drug reactionsOffers case studies that illustrate real-life clinical situations and discusses important concepts related to PE and PV

1. Introduction 2. The role of pharmacoepidemiologic research in drug development 3. Pharmaco-epidemiology in the prevention of adverse drug reactions 4. Case Studies