Pharmacovigilance: A Practical Approach
Written by experts in the field of pharmacovigilance and patient safety, this concise resource provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. Drs. Thao Doan, Cheryl Renz, Fabio Lievano, Mondira...
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Written by experts in the field of pharmacovigilance and patient safety, this concise resource provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. Drs. Thao Doan, Cheryl Renz, Fabio Lievano, Mondira Bhattacharya, and Linda Scarazzini provide essential information for health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance.
Covers the evolving regulatory landscape, as well as current and future use of digital technologies. Uses case studies to ensure content is relevant to everyday practice. Discusses behavioral science and patient perspectives, risk communication, and new frontiers in pharmacovigilance. Consolidates today's available information on this timely topic into one convenient resource.
Bibliographische Angaben
- Herausgegeben:Doan, Thao; Scarazzini, Linda; Renz, Cheryl; Lievano, Fabio; Bhattacharya, Mondira
- Verlag: ELSEVIER
- EAN: 9780323581165
Inhaltsverzeichnis zu „Pharmacovigilance: A Practical Approach “
Introduction1. Does Regulation Drive Science or Does Science Drive Regulation?2. Role of Epidemiology in Pharmaceutical Industry3. Real World Epidemiologic Studies and Patient RegistriesSection III. Benefit-Risk in the Drug Development Life Cycle4. Signal Management and Methods of Signal Detection5. Causality Assessment and Examples of Adverse Drug Reactions (Drug Induced Liver Injury, Skin, Major Adverse Cardiac Events and Renal) 6. Product Safety Monitoring in Clinical Trials7. Benefit-Risk Assessments8. Communicating benefit risk9. Pharmacovigilance and Medical Devices 10. Vaccine Safety Surveillance11. Pharmacovigilance in Special Populations (Pediatrics and Elderly)12. Pharmacovigilance in Pregnancy13. Impact and Implications of Technology on Pharmacovigilance14. The Future of Pharmacovigilance
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