by Nigel Dent
and Ramzan Visanji

This book is a guide to both the novice and the established practitioner, offering alternative ways of conducting clinical trials that are in compliance with regulations. A global panel of experts shares its experiences in clinical studies involving all of the major species.

Contents

1. Setting Up Studies to GCP
2. International Harmonization & Studies to Support Approval of New Animal Drugs: US Perspective
3. Role of the Investigator
4. Role of the Monitor
5. QA on Veterinary Clinical Trials in the US
6. GCP Trials in Fish
7. GCP Trials in Poultry
8. GCP Trials in Companion Animals
9. GCP Trials in Pigs
10. GCP Trials in Calves
11. GCP Trials in Sheep
12. GCP Trials in Horses & Ponies
13. Genetically Modified Micro-organisms & GCP Studies
14. Contract Research Farms & Their Involvement with GCP Studies
15. The Practising Veterinarian's Role
16. SOPs
17. The Generic Protocol
18. How to Write the Study Report
19. Data, Statistical Analysis & Reporting
20. Registration Submissions for Veterinary Medicines
21. Large-Scale Production of Ectoparasites
22. Auditing
23. Multisite Studies

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