This reference book from Jaypee Brothers Medical Publishers is an English medium (अंग्रेजी माध्यम) book on Pharmacovigilance, edited by SK Gupta and Sushma Srivastava with contributions from specialists in drug safety, prepared for postgraduate students of pharmacology and pharmacy, drug safety and clinical research professionals, regulatory affairs personnel, and also useful for MBBS, BDS and nursing students who must understand adverse drug reaction reporting as part of their curriculum. As its subtitle indicates, the book is built around a single purpose — ensuring the safe use of medicines — and works through how a drug's safety profile, necessarily incomplete at the time of approval, is completed by systematic post-marketing surveillance. This Second Edition covers the history, principles and scope of pharmacovigilance; classification, mechanisms and predisposing factors of adverse drug reactions (प्रतिकूल औषधि प्रभाव); spontaneous reporting systems and the problem of under-reporting; causality assessment using the WHO-UMC and Naranjo scales; seriousness, severity and expectedness criteria; individual case safety reports and case processing; MedDRA coding and safety databases; signal detection, data mining and signal management; periodic safety update reports and post-marketing surveillance studies; risk management plans and risk minimisation measures; medication errors and drug interactions; pharmacovigilance in pregnancy, paediatrics, geriatrics and other special populations; vaccine safety and adverse events following immunisation; herbal and traditional medicine safety; and the Pharmacovigilance Programme of India (PvPI) together with the CDSCO, ICH and WHO regulatory framework. All content, terminology and explanations in this book are presented in the English language only.
Key Features:
English medium book — complete content, terminology and explanations in English
Edited by SK Gupta and Sushma Srivastava, published by Jaypee Brothers Medical Publishers
Second Edition, revised and updated
Multi-contributor reference written by specialists in drug safety
Indian regulatory framework covered alongside international guidelines
Reporting forms, worked case examples and assessment scales included
Diagrams, flowcharts and tables for quick reference
Written for pharmacology and pharmacy postgraduates and drug safety professionals
Also useful for MBBS, BDS and nursing students for ADR reporting competencies
History, principles and scope of pharmacovigilance
Classification, mechanisms and predisposing factors of adverse drug reactions
Spontaneous reporting systems and causes of under-reporting
Causality assessment using WHO-UMC and Naranjo scales
Seriousness, severity and expectedness assessment
Individual case safety reports and case processing workflow
MedDRA coding and pharmacovigilance safety databases
Signal detection, data mining and signal management
Periodic safety update reports and post-marketing surveillance studies
Risk management plans and risk minimisation measures
Medication errors, drug interactions and drug-induced organ toxicity
Pharmacovigilance in pregnancy, paediatrics, geriatrics and special populations
Vaccine safety and adverse events following immunisation (AEFI)
Safety monitoring of herbal and traditional medicines
Pharmacovigilance Programme of India (PvPI), CDSCO, ICH and WHO guidelines
Useful for postgraduate examinations, professional certification and practice in drug safety
Pharmacology एवं Pharmacy के स्नातकोत्तर विद्यार्थियों, drug safety व clinical research professionals तथा regulatory affairs कर्मियों के लिए Jaypee Brothers Medical Publishers द्वारा प्रकाशित यह "Textbook of Pharmacovigilance — Ensuring the Safe Use of Medicines" (2nd Edition) पुस्तक SK Gupta एवं Sushma Srivastava द्वारा संपादित है; यह MBBS, BDS एवं नर्सिंग विद्यार्थियों के लिए भी उपयोगी है। इसमें pharmacovigilance के सिद्धांत, प्रतिकूल औषधि प्रभावों का वर्गीकरण, spontaneous reporting, WHO-UMC एवं Naranjo scales द्वारा causality assessment, case processing एवं MedDRA coding, signal detection, PSUR, risk management plans, medication errors, विशेष जनसंख्या में pharmacovigilance, vaccine safety एवं AEFI, हर्बल औषधि सुरक्षा तथा PvPI, CDSCO, ICH व WHO गाइडलाइंस को reporting forms, चित्रों एवं तालिकाओं सहित समझाया गया है। सम्पूर्ण पुस्तक अंग्रेजी माध्यम (English medium) में है, इसमें हिंदी माध्यम की सामग्री सम्मिलित नहीं है।
