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書籍

動物用医薬品の安全性監視 Veterinary Pharmacovigilance

動物用医薬品の安全性監視 Veterinary Pharmacovigilance
動物用医薬品の安全性監視 Veterinary Pharmacovigilance:
Adverse Reactions to Veterinary Medicinal Products
Edited by Kevin Woodward, Intervet/Schering-Plough Animal Health, UK
ISBN: 978-1-4051-6968-4
Hardcover
784 pages
MAY 2009
価格: US$240.00
ダウンロード
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解説/DESCRIPTION

動物用の医薬品が引き起こす副作用は、投薬される動物だけでなく、周囲の人や環境にも影響を与えかねない。また、動物を起原とする食物に残存した医薬品が人に副作用を起こすこともある。これらの懸念から、各国では動物に用いられる医薬品の安全性を監視する機関の設立や、規制の制定が進められてきた。本書は、こういった問題に対して多角的かつ詳細な検討を加える。編者はこの分野で20年以上の豊富な経験を持ち、それぞれの主題の専門家からの寄稿を集めている。

目次/TABLE OF CONTENTS

1. Elements of Veterinary Pharmacovigilance
2. Veterinary Pharmacovigilance in the European Union
3. Pharmacovigilance and the European Medicines Agency: Conduct of harmacovigilance Activities
4. Veterinary Pharmacovigilance in France
5. Pharmacovigilance in Germany
6. Veterinary Pharmacovigilance: the UK Experience
7. Veterinary Adverse Drug Reporting in the United States, Australia and Canada
8. Veterinary Pharmacovigilance: A South African Perspective
9. Pharmacovigilance Inspections in the European Union
10. Essential Elements of Veterinary Pharmacovigilance and the Role and Duties of the Qualified Person
11. Veterinary Pharmacovigilance in an Industry Setting: The EU
12. Pharmacovigilance in the US: Industry Perspective
13. Practical Veterinary Pharmacovigilance
14. Preclinical Safety Testing and Assessment of Veterinary Pharmaceuticals and Pharmacovigilance
15. Safety Assessment of Veterinary Vaccines
16. Microbiological Assessment of Veterinary Medicinal Products and Potential Adverse Effects
17. Adverse Effects of Veterinary Pharmaceutical Products in Animals
18. Adverse Drug Reactions in Dogs: Toxic Hepatic Responses
19. Adverse Reactions to Vaccines
20. Adverse Reactions in Humans Following Exposure to Veterinary Drugs
21. Medicines Used to Control and Treat External Parasites of Sheep: Toxicology and The Phenomenon of Reported Adverse Human Responses to Organophosphorus Sheep Dips
22. User Safety Assessment of Veterinary Medicinal Products
23. Maximum Residue Limits
24. Determination of Withdrawal Periods for Pharmaceutical Products Used in Food Animals
25. Surveillance for Veterinary Residues
26. Adverse Environmental Effects and Veterinary Medicinal Products
27. Causality in Pharmacovigilance and Expectedness of Adverse Reactions
28. Quantitative Aspects of Veterinary Pharmacovigilance
29. Veterinary Adverse Reactions and Crisis Management
30. The Role of Veterinary Pharmacovigilance in Risk Analysis and the Influence of Risk Perception on Veterinary Pharmacovigilance
31. The Role of Quality Assurance in Veterinary Pharmacovigilance
32. Concordance Between Results from Animal Toxicology Studies and Adverse Reactions in Animals