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
Dr. Plourde is a senior clinic evaluator for the Health Canada's regulatory agency. He is an associate professor in the department of clinical pharmacology and physiology, Faculty of Medicine at the University of Montreal and at the school of physical activity sciences, Faculty of Health Sciences at the University of Ottawa. He holds a doctorate in medicine (MD) from the University of Montreal, a PhD in experimental medicine from Laval University. His studies led him to publish several articles in highly rated peer-reviewed journals and to make numerous presentations for prestigious associations at National and International levels. He has more than 12 years experienced working on drug safety, especially for biologic products involved in the treatment of various cancers. Since more than 4 years he is suffering from prostate cancer with metastasis to the lungs and bones. Therefore, during the past 4 years he learned a lot on prostate cancer from the medical literature and from discussions with various specialists. The case report presented in this book represents is its own medical history. This book will provide the most relevant and up to date information on the various aspects involved in the screening, diagnosis and treatment of prostate cancer.
Sabrina Nour is a Clinical Evaluator and Epidemiologist where she is in charge of reviewing the efficacy and safety of biological products. She holds a Master's degree in epidemiology and a certificate in population risk evaluation and health management. Sabrina has acquired more than 6 years of experience working on drug safety and pharmacovigilance, including pharmacoepidemiology. Her major interests lie in pharmacoepidemiology methodology, pharmacovigilance activities, and in the influence of health policies on populations.