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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.
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