Veterinary Pharmacovigilance: Adverse Reactions to Veterinary Medicinal Products

Description

Veterinary Pharmacovigilance: Adverse Reactions to Veterinary Medicinal Products is an in-depth examination of veterinary pharmacovigilance, looking at the scientific methodologies involved, the role of regulatory agencies and legislation, and the underpinning science. Edited by a renowned expert, with over 20 years experience in the field, it draws together the expertise of authors from around the world. Adverse drug reactions may become apparent in treated animal patients, in exposed users or as adverse effects on the environment. They may also manifest as excess drug residues in food of animal origin. As a consequence, legislation and regulatory approaches have developed to address these issues and to ensure monitoring of continued product safety and, where necessary, the use of regulatory actions. All of these aspects are covered by the term “pharmacovigilance”.Veterinary pharmacovigilance is a rapidly growing discipline in both regulatory and scientific terms, and its importance can only increase as regulatory agencies across the globe seek to improve their hazard and risk assessment of marketed veterinary medicines by applying the techniques of post-marketing surveillance. Its roots include veterinary medicine, medicine, pharmacology, toxicology, pathology and, increasingly, ecotoxicity and environmental safety. This book will be fundamentally important reading for all involved in the field of veterinary pharmacovigilance including veterinarians, physicians, environmental scientists, regulators and those involved in drug development and market maintenance.Content: Chapter 1 Elements of Veterinary Pharmacovigilance (pages 9–17): K. N. WoodwardChapter 2 Veterinary Pharmacovigilance in the European Union (pages 19–46): K. N. WoodwardChapter 3 Pharmacovigilance and the European Medicines Agency: Conduct of Pharmacovigilance Activities (pages 47–54): K. GreinChapter 4 Veterinary Pharmacovigilance in France (pages 55–64): G. Keck and X. PineauChapter 5 Pharmacovigilance in Germany (pages 65–90): C. Ibrahim and A. WilkeChapter 6 Veterinary Pharmacovigilance – the UK Experience (pages 91–117): K. N. WoodwardChapter 7 Veterinary Adverse Drug Event Reporting in the United States, Australia and Canada (pages 119–149): K. N. WoodwardChapter 8 Veterinary Pharmacovigilance: a South African Perspective (pages 151–162): V. NaidooChapter 9 Pharmacovigilance Inspections in the European Union (pages 163–175): K. N. Woodward and C. W. EvansChapter 10 Essential Elements of Veterinary Pharmacovigilance and the Role and Duties of the Qualified Person (pages 177–208): B. CornezChapter 11 Veterinary Pharmacovigilance in an Industry Setting – the European Union (pages 209–230): M. O'gormanChapter 12 Pharmacovigilance in the US – an Industry Perspective (pages 231–285): T. M. HodgeChapter 13 Practical Veterinary Pharmacovigilance (pages 287–295): D. O'rourkeChapter 14 Preclinical Safety Testing and Assessment of Veterinary Pharmaceuticals and Pharmacovigilance (pages 297–345): K. N. WoodwardChapter 15 Safety Assessment of Veterinary Vaccines (pages 347–354): M. J. FrancisChapter 16 Microbiological Assessment of Veterinary Medicinal Products and Potential Adverse Effects (pages 355–392): P. SilleyChapter 17 Adverse Effects of Veterinary Pharmaceutical Products in Animals (pages 393–421): K. N. WoodwardChapter 18 Adverse Drug Reactions in Dogs – Toxic Hepatic Responses (pages 423–452): K. N. WoodwardChapter 19 Adverse Reactions to Vaccines (pages 453–473): K. N. Woodward and L. A. ToonChapter 20 Adverse Reactions in Humans Following Exposure to Veterinary Drugs (pages 475–515): K. N. WoodwardChapter 21 Medicines Used to Control and Treat External Parasites of Sheep – Toxicology and the Phenomenon of Reported Adverse Human Responses to Organophosphorus Sheep Dips (pages 517–527): T. C. Marrs and P. EdwardsChapter 22 User Safety Assessment of Veterinary Medicinal Products (pages 529–545): K. N. WoodwardChapter 23 Maximum Residue Limits (pages 547–567): K. N. WoodwardChapter 24 Determination of Withdrawal Periods for Pharmaceutical Products Used in Food Animals (pages 569–585): R. C. ParkerChapter 25 Surveillance for Veterinary Residues (pages 587–604): K. N. WoodwardChapter 26 Adverse Environmental Effects and Veterinary Medicinal Products (pages 605–638): A. TaitChapter 27 Causality in Pharmacovigilance and Expectedness of Adverse Reactions (pages 639–657): K. N. WoodwardChapter 28 Quantitative Aspects of Veterinary Pharmacovigilance (pages 659–672): K. N. WoodwardChapter 29 Veterinary Adverse Reactions and Crisis Management (pages 673–689): K. N. WoodwardChapter 30 The Role of Veterinary Pharmacovigilance in Risk Analysis and the Influence of Risk Perception on Veterinary Pharmacovigilance (pages 691–708): H. P. A. IllingChapter 31 The Role of Quality Assurance in Veterinary Pharmacovigilance (pages 709–714): R. Visanji and H. Politis?NortonChapter 32 Concordance between Results from Animal Toxicology Studies and Adverse Reactions in Animals (pages 715–748): K. N. Woodward