1st Edition
by Sabrina Nour (Author), Gilles Plourde (Author)
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.
- 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
