1st Edition

Veterinary Clinical Trials From Concept to Completion

By Nigel Dent, Ramzan Visanji Copyright 2001

    Conceived and edited by Nigel Dent and Ramzan Visanji, Veterinary Clinical Trials form Concept to Completion is designed for both established practitioners and novices, offering alternative ways of conducting studies and ensuring that the studies are guided by Good Clinical Practices and are in compliance with regulations. Comprehensive in scope, it provides the scientific, biological, and regulatory background invaluable to teachers, researchers, and regulatory affairs staff, as well as those directly involved in clinical trials.

    The book covers:

  • Objectives of the clinical study
  • Control of the study
  • Conduct of the study
  • Regulation versus compliance
  • Factors for success
  • International harmonization activities
  • Roles of the investigator, the monitor, and the practicing veterinarian
  • Setting up GCP trials with particular animal species
  • SOPs, the generic protocol, and the study report
  • Contract research farms and multi-site studies
  • Auditing

    With contributions from experts in every area of veterinary trials, the text has been organized with everyday use in mind. The chapters can be read sequentially for a comprehensive view or individually for coverage of particular topics and issues as needed. Drawing directly from the in-the-trenches experience of the editors and chapter authors, the book is a guide to methods that ensure studies meet regulatory compliance and strategies that ensure avoidance of common pitfalls.
  • Introduction and Overview of Setting Up Studies to Good Clinical Practice, N. Dent

    International Harmonization and the Conduct of Clinical Studies to Support the Approval of New Animal Drugs: The U.S. Perspective, H.M. Schoenemann, III

    The Role of the Investigator, M. Proven

    The Role of the Monitor, A.W. Hill

    Quality Assurance on Veterinary Clinical Trials, R. Muser

    Setting Up GCP Trials in Fish, J. Stone and A. McLean

    Setting GCP Trials in Poultry, R.J. Grant

    Setting Up GCP Trials in Companion Animals, S. Lester

    Setting Up GCP Trials in Pigs, A.R. Peters

    Setting Up GCP Trials in Calves, J. Murray

    Setting Up GCP Trials in Sheep, J. Barley

    Setting Up GCP Trials in Horses and Ponies, D. Baker

    Genetically Modified Micro-Organisms and GCP Studies, V. Carn

    Contract Research Farms and Their Involvement with GCP Studies, B. Drew and H. Biggadike

    The Practicing Veterinarian's Role in Clinical Trials, J. Carr

    Standard Operating Procedures, R. Visanji

    The Generic Protocol, C. Dent

    How to Write the Final Study Report, K.L. Ankenbauer-Perkins and A.M. Alexander

    Data, Statistical Analysis and Reporting for Veterinary Clinical Trials, G. Gettinby

    Registration Submissions for Veterinary Medicines, G. Cowan

    Large-Scale Production of Ectoparasites for Use in Veterinary Trials, M. Murphy, L. Moran, S. Conroy, and C. Caulfield

    Auditing GCP Trials, Z. Carr

    Multisite Studies, L. Whitfield



    Ramzan Visanji, Nigel Dent