Textbook of Pharmacovigilance: Ensuring the Safe Use of Medicines (2nd Revised Edition)

Description

This is the updated second edition of the Textbook of Pharmacovigilance: Ensuring the Safe Use of Medicine. All the chapters have been updated and new chapters like Pharmacoepidemiology and Pharmacovigilance, Hospitalization due to Adverse Drug Reactions and its Economic Burden, and Vigilance Systems for Medical Devices have been added.

This book will be useful for the healthcare professionals, postgraduate students, industry professionals and those engaged in clinical research at academia and the pharmaceutical industry.

Key Features

• Introduction to Pharmacovigilance-basic definitions, classifications, objectives and historical perspective of pharmacovigilance.
• Presents the revised and updated information about the various aspects of pharmacovigilance such as setting up of a pharmacovigilance centre, regulations in various countries, methods of pharmacovigilance, benefit-risk assessment, signal detection, postmarketing surveillance, etc.
• Inclusion of need-felt text on latest issues of pharmacovigilance, such as Pharmacoepidemiology and pharmacovigilance; Pharmacoeconomic burden of hospitalization due to adverse drug reactions; Vigilance systems for medical devices; and Data management in pharmacovigilance.

Table of contents

1. Key Definitions in Pharmacovigilance
2. Pharmacovigilance: Historical Perspective
3. Pharmacovigilance: Need and Objectives
4. Current Methods of Pharmacovigilance
5. Adverse Drug Reactions: Classification, Mechanism and Interaction
6. Signal Detection in Pharmacovigilance
7. Postmarketing Surveillance
8. Setting up of a Pharmacovigilance Centre
9. Benefit-Risk Assessment in Pharmacovigilance
10. Crisis Management in Pharmacovigilance
11. WHO Pharmacovigilance: Programme for Global Drug Monitoring
12. Pharmacovigilance of Herbal Drugs
13. Medical Dictionary for Regulatory Activities: An Overview
14. Pharmacogenetics and Pharmacovigilance
15. Pharmacovigilance Regulations in Various Countries
16. Pharmacoepidemiology and Pharmacovigilance
17. Hospitalization due to Adverse Drug Reactions and its Economic Burden
18. Vigilance Systems for Medical Devices
19. Data Mangement in Pharmacovigilance
20. Annexures
21. Index

Authors Biography

SK Gupta PhD DSc FIPS FIACS

Sushma Srivastava PhD PDCR