Veterinary Pharmacovigilance (PDF)
Adverse Reactions to Veterinary Medicinal Products
(Sprache: Englisch)
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...
Medicinal Products is an in-depth examination of veterinary
pharmacovigilance, looking at the scientific methodologies
involved, the role of regulatory agencies and legislation, and...
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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.
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.
Inhaltsverzeichnis zu „Veterinary Pharmacovigilance (PDF)“
Introduction. D Skilton. 1. Elements of Veterinary Pharmacovigilance. K N Woodward. 2. Veterinary Pharmacovigilance in the European Union. K N Woodward. 3. Pharmacovigilance and the European Medicines Agency: Conduct of Pharmacovigilance Activities. K Grein. 4. Veterinary Pharmacovigilance in France. G Keck and X Pineau. 5. Pharmacovigilance in Germany. C Ibrahim and A Wilke. 6. Veterinary Pharmacovigilance: the UK Experience. K N Woodward. 7. Veterinary Adverse Drug Reporting in the United States, Australia and Canada. K N Woodward. 8. Veterinary Pharmacovigilance: A South African Perspective. V Naidoo. 9. Pharmacovigilance Inspections in the European Union. K N Woodward and C Evans. 10. Essential Elements of Veterinary Pharmacovigilance and the Role and Duties of the Qualified Person. B Cornez. 11. Veterinary Pharmacovigilance in an Industry Setting: The EU. M O'Gorman. 12. Pharmacovigilance in the US: Industry Perspective. T M Hodge. 13. Practical Veterinary Pharmacovigilance. D O'Rourke. 14. Preclinical Safety Testing and Assessment of Veterinary Pharmaceuticals and Pharmacovigilance. K N Woodward. 15. Safety Assessment of Veterinary Vaccines. M J Francis. 16. Microbiological Assessment of Veterinary Medicinal Products and Potential Adverse Effects. P Silley. 17. Adverse Effects of Veterinary Pharmaceutical Products in Animals. K N Woodward. 18. Adverse Drug Reactions in Dogs: Toxic Hepatic Responses. K N Woodward. 19. Adverse Reactions to Vaccines. K N Woodward and L Toon. 20. Adverse Reactions in Humans Following Exposure to Veterinary Drugs. K N Woodward. 21. Medicines Used to Control and Treat External Parasites of Sheep: Toxicology and The Phenomenon of Reported Adverse Human Responses to Organophosphorus Sheep Dips. T C Marrs and P Edwards. 22. User Safety Assessment of Veterinary Medicinal Products. K N Woodward. 23. Maximum Residue Limits. K N Woodward. 24. Determination of Withdrawal Periods for Pharmaceutical Products Used in Food Animals. R C Parker.
... mehr
25. Surveillance for Veterinary Residues. K N Woodward. 26. Adverse Environmental Effects and Veterinary Medicinal Products. A Tait. 27. Causality in Pharmacovigilance and Expectedness of Adverse Reactions. K N Woodward. 28. Quantitative Aspects of Veterinary Pharmacovigilance. K N Woodward. 29. Veterinary Adverse Reactions and Crisis Management. K N Woodward. 30. The Role of Veterinary Pharmacovigilance in Risk Analysis and the Influence of Risk Perception on Veterinary Pharmacovigilance. H P A Illing. 31. The Role of Quality Assurance in Veterinary Pharmacovigilance. R Visanji and H Politis-Norton. 32. Concordance Between Results from Animal Toxicology Studies and Adverse Reactions in Animals. K N Woodward
... weniger
Autoren-Porträt
Dr K.N. Woodward is Director of International RegulatoryAffairs at Intervet/Schering-Plough Animal Health in the UK and has
been involved in veterinary pharmacovigilance for over 20 years. He
was formerly the Director of Licensing at the Veterinary Medicines
Directorate (VMD) in the UK. He has also worked for the Health and
Safety Executive on the regulation of industrial chemicals and
non-agricultural pesticides and for the Department of Health where
he was Scientific Secretary to the Committee on Carcinogenicity and
held responsibilities for the safety of veterinary drugs. A
toxicologist, he was Chairman of the Working Group on the Safety of
Residues of the Committee for Veterinary Medicinal Products (CVMP,
now the Committee for Medicinal Products for Veterinary Use) for
over 5 years and a member of the CVMP. He was the leader of the UK
delegation to the Codex Committee on Residues of Veterinary Drugs
in Food in Washington for 3 years and a member of the Joint FAO/WHO
Expert Committee on Food Additives (JECFA).
Bibliographische Angaben
- 2009, 1. Auflage, 776 Seiten, Englisch
- Herausgegeben: Kevin Woodward
- Verlag: John Wiley & Sons
- ISBN-10: 144432294X
- ISBN-13: 9781444322941
- Erscheinungsdatum: 09.11.2009
Abhängig von Bildschirmgröße und eingestellter Schriftgröße kann die Seitenzahl auf Ihrem Lesegerät variieren.
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