Veterinary Pharmacovigilance. Adverse Reactions to Veterinary Medicinal Products

  • ID: 2222550
  • Book
  • 776 Pages
  • John Wiley and Sons Ltd
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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.

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List of contributors ix

Preface xi

Acknowledgements xiii

Introduction 1D. Skilton

1 Elements of veterinary pharmacovigilance 9K.N. Woodward

2 Veterinary pharmacovigilance in the European Union 19K.N. Woodward

3 Pharmacovigilance and the European Medicines Agency: conduct of pharmacovigilance activities 47K. Grein

4 Veterinary pharmacovigilance in France 55G. Keck and X. Pineau

5 Pharmacovigilance in Germany 65C. Ibrahim and A. Wilke

6 Veterinary pharmacovigilance the UK experience 91K.N. Woodward

14 Preclinical safety testing and assessment of veterinary pharmaceuticals and pharmacovigilance 297K.N. Woodward

15 Safety assessment of veterinary vaccines 347M.J. Francis

16 Microbiological assessment of veterinary medicinal products and potential adverse effects 355P. Silley

17 Adverse effects of veterinary pharmaceutical products in animals 393K.N. Woodward

18 Adverse drug reactions in dogs toxic hepatic responses 423K.N. Woodward

19 Adverse reactions to vaccines 453K.N. Woodward and L.A. Toon

20 Adverse reactions in humans following exposure to veterinary drugs 475K.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 517T.C. Marrs and P. Edwards

22 User safety assessment of veterinary medicinal products 529K.N. Woodward

23 Maximum residue limits 547K.N. Woodward

24 Determination of withdrawal periods for pharmaceutical products used in food animals 569R.C. Parker

25 Surveillance for veterinary residues 587K.N. Woodward

26 Adverse environmental effects and veterinary medicinal products 605A. Tait

27 Causality in pharmacovigilance and expectedness of adverse reactions 639K.N. Woodward

28 Quantitative aspects of veterinary pharmacovigilance 659K.N. Woodward

29 Veterinary adverse reactions and crisis management 673K.N. Woodward

30 The role of veterinary pharmacovigilance in risk analysis and the influence of risk perception on veterinary pharmacovigilance 691H.P.A. Illing

31 The role of quality assurance in veterinary pharmacovigilance 709R. Visanji and H. Politis–Norton

32 Concordance between results from animal toxicology studies and adverse reactions in animals 715K.N. Woodward

Index 751

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Kevin Woodward
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