1st Edition
Veterinary Clinical Trials From Concept to Completion
348 Pages
by
CRC Press
348 Pages
by
CRC Press
Also available as eBook on:
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:
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
Appendices
Index
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
Appendices
Index
Biography
Ramzan Visanji, Nigel Dent
