Veterinary Pharmacovigilance (eBook)
776 Seiten
John Wiley & Sons (Verlag)
978-1-4443-2294-1 (ISBN)
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.
Dr K.N. Woodward is Director of International Regulatory Affairs 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).
List 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
"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)
Erscheint lt. Verlag | 24.11.2009 |
---|---|
Sprache | englisch |
Themenwelt | Medizin / Pharmazie |
Veterinärmedizin ► Klinische Fächer ► Pharmakologie / Toxikologie | |
Schlagworte | Veterinärmedizin • Veterinärmedizin / Pharmakologie, Toxikologie, Therapeutik • Veterinärmedizin • Veterinärmedizin / Pharmakologie, Toxikologie, Therapeutik • Veterinary Medicine • Veterinary Pharmacology, Toxicology & Therapeutics |
ISBN-10 | 1-4443-2294-X / 144432294X |
ISBN-13 | 978-1-4443-2294-1 / 9781444322941 |
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