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Chapter-09 Role of Pharmacovigilance in Clinical Research

BOOK TITLE: Drug Discovery and Clinical Research

Author
1. Gupta SK
2. Sharma Manoj
3. Moore Nicholas
4. Chatterjee Arani
ISBN
9789350252727
DOI
10.5005/jp/books/11216_9
Edition
1/e
Publishing Year
2011
Pages
42
Author Affiliations
1. Delhi Pharmaceutical Sciences and Research University (DPSRU), New Delhi, India; All India Institute of Medical Sciences (AIIMS), New Delhi, India, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India
3. Service Hospitalo-Universitaire de PharmacologieUniversité de Bordeaux, Bâtiment 1A Zone nord Site Carreire BP36 33076, Bordeaux, France
4. Panacea Biotec Ltd., B-1 Ext. /G-3, Mohan Cooperative Industrial, Estate Mathura Road, New Delhi, India, Panacea Biotec Ltd, B-1 Ext/G-3, Mohan Co-operative Industrial Estate, Mathura Road, New Delhi, India
Chapter keywords
Pharmacovigilance, anaphylaxis, adverse drug reactions, International Drug Monitoring, National Pharmacovigilance Program, aplastic anemia, toxic epidermal necrolysis, Stevens-Johnson syndrome, Passive Surveillance, drug event monitoring, troglitazone, good clinical practice (GCP), Case report, Cross-sectional Study, Targeted Clinical Investigations, clinical trials, Pharmaceutical industry, investigator’s brochure (ib), cell therapy, gene therapy, Scopus, Pubmed, Cochrane database, Sibutramine, Ectiva, Lindaxa, Meissa, Meridia, Minimacin, Minimectil, Obesan, placebo, Sibutramine cardiovascular outcome trial (SCOUT), efalizumab, cyclosporin, methotrexate, multifocal leukoencephalopathy (PML), Acomplia, lumiracoxib, osteoarthritis, hepatotoxicity, cholestatic hepatitis, hepatic necrosis and hepatic failure, Strattera, drug development process, SCOUT study, COX-2 inhibitors, COX-2 selective agents

Abstract

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