Description
Book SynopsisVeterinary 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 scientif
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"In terms of utility to the practical toxicologist, the book is excellent and I am very pleased to have it on my shelf - well away from the door." (British Toxicology Society, Winter 2010)
Table of ContentsList of contributors ix
Preface xi
Acknowledgements xiii
Introduction 1
D. Skilton
1 Elements of veterinary pharmacovigilance 9
K.N. Woodward
2 Veterinary pharmacovigilance in the European Union 19
K.N. Woodward
3 Pharmacovigilance and the European Medicines Agency: conduct of pharmacovigilance activities 47
K. Grein
4 Veterinary pharmacovigilance in France 55
G. Keck and X. Pineau
5 Pharmacovigilance in Germany 65
C. Ibrahim and A. Wilke
6 Veterinary pharmacovigilance – the UK experience 91
K.N. Woodward
14 Preclinical safety testing and assessment of veterinary pharmaceuticals and pharmacovigilance 297
K.N. Woodward
15 Safety assessment of veterinary vaccines 347
M.J. Francis
16 Microbiological assessment of veterinary medicinal products and potential adverse effects 355
P. Silley
17 Adverse effects of veterinary pharmaceutical products in animals 393
K.N. Woodward
18 Adverse drug reactions in dogs – toxic hepatic responses 423
K.N. Woodward
19 Adverse reactions to vaccines 453
K.N. Woodward and L.A. Toon
20 Adverse reactions in humans following exposure to veterinary drugs 475
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 517
T.C. Marrs and P. Edwards
22 User safety assessment of veterinary medicinal products 529
K.N. Woodward
23 Maximum residue limits 547
K.N. Woodward
24 Determination of withdrawal periods for pharmaceutical products used in food animals 569
R.C. Parker
25 Surveillance for veterinary residues 587
K.N. Woodward
26 Adverse environmental effects and veterinary medicinal products 605
A. Tait
27 Causality in pharmacovigilance and expectedness of adverse reactions 639
K.N. Woodward
28 Quantitative aspects of veterinary pharmacovigilance 659
K.N. Woodward
29 Veterinary adverse reactions and crisis management 673
K.N. Woodward
30 The role of veterinary pharmacovigilance in risk analysis and the influence of risk perception on veterinary pharmacovigilance 691
H.P.A. Illing
31 The role of quality assurance in veterinary pharmacovigilance 709
R. Visanji and H. Politis-Norton
32 Concordance between results from animal toxicology studies and adverse reactions in animals 715
K.N. Woodward
Index 751
