Textbook of Pharmacovigilance: Ensuring the Safe Use of Medicines, 2/E for Pharmacy and Pharmacology Postgraduates | Drug Safety, Signal Detection and Regulatory Practice Reference Guide

Textbook of Pharmacovigilance: Ensuring the Safe Use of Medicines, 2/E , edited by SK Gupta and Sushma Srivastava, presents a revised and updated account of how drug safety is monitored after a medicine reaches the market. The book opens with the basic definitions, classifications, objectives, and historical perspective of pharmacovigilance before building into its current practice. It covers setting up a pharmacovigilance centre, regulations across countries, methods of pharmacovigilance, benefit-risk assessment, and signal detection, alongside postmarketing surveillance systems. This edition adds need-felt content on pharmacoepidemiology, the pharmacoeconomic burden of hospitalization due to adverse drug reactions, vigilance systems for medical devices, and data management in pharmacovigilance. Written by a team of pharmacology and pharmacovigilance experts, the book is structured as a scholarly reference that moves from foundational concepts through regulatory practice to the emerging issues shaping drug safety today. Who This Book Is For: M.Pharm and B.Pharm Students: get a structured foundation in adverse drug reaction classification, causality assessment, and pharmacovigilance methods. Pharmacology Postgraduates: use the benefit-risk assessment and signal detection chapters to build research and regulatory competence. PG Teaching Faculty: reference the revised regulatory and methods chapters when teaching pharmacovigilance to graduate and postgraduate classes. Medical Research Workers and Industry Professionals: apply the postmarketing surveillance and data management chapters directly to regulatory and pharmacovigilance practice. Why This Book Helps: Covers the full pharmacovigilance lifecycle: moves from definitions and history through active monitoring methods to postmarketing surveillance in one reference. Adds emerging-issue chapters: pharmacoepidemiology, medical device vigilance, and data management address gaps left by older pharmacovigilance texts. Builds regulatory literacy: the country-by-country regulations chapter helps readers understand how pharmacovigilance is implemented in practice, not just in theory. Structures ADR reasoning: classification by mechanism, severity, seriousness, and WHO-UMC causality gives readers a consistent framework for evaluating adverse events. Key Features: Revised and updated chapters on pharmacovigilance centre setup, regulations, methods, and postmarketing surveillance Dedicated new-issue chapters on pharmacoepidemiology and pharmacoeconomic burden of ADR-related hospitalization Coverage of vigilance systems for medical devices and data management in pharmacovigilance WHO-UMC causality classification and full ADR classification framework (pharmacological, severity, seriousness, mechanism) Written for teachers, research fellows, and graduate/postgraduate students of pharmacy, pharmacology, and medicine

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