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Pharmacovigilance: A Practical Approach

Editat de Thao Doan, Linda Scarazzini, Cheryl Renz, Fabio Lievano, Mondira Bhattacharya
en Limba Engleză Paperback – 2 aug 2018
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.
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Specificații

ISBN-13: 9780323581165
ISBN-10: 0323581161
Pagini: 228
Ilustrații: 100 illustrations (100 in full color)
Dimensiuni: 191 x 235 x 16 mm
Greutate: 0.48 kg
Editura: Elsevier

Cuprins

Introduction
1. Does Regulation Drive Science or Does Science Drive Regulation?
2. Role of Epidemiology in Pharmaceutical Industry
3. Real World Epidemiologic Studies and Patient Registries
Section III. Benefit-Risk in the Drug Development Life Cycle
4. Signal Management and Methods of Signal Detection
5. 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 Trials
7. Benefit-Risk Assessments
8. Communicating benefit risk
9. Pharmacovigilance and Medical Devices
10. Vaccine Safety Surveillance
11. Pharmacovigilance in Special Populations (Pediatrics and Elderly)
12. Pharmacovigilance in Pregnancy
13. Impact and Implications of Technology on Pharmacovigilance
14. The Future of Pharmacovigilance