Veterinary Clinical Trials From Concept to Completion
Book Details
Format
Hardback or Cased Book
ISBN-10
157491121X
ISBN-13
9781574911213
Publisher
Taylor & Francis Inc
Imprint
CRC Press Inc
Country of Manufacture
US
Country of Publication
GB
Publication Date
Dec 31st, 2001
Print length
348 Pages
Weight
907 grams
Product Classification:
Mathematics & scienceMathematics and Science
Ksh 94,500.00
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Explores how to conduct studies and ensure that the studies are guided by GCPs and are in compliance with regulations. This work provides the scientific, biological, and regulatory background suitable for teachers, researchers and regulatory affairs staff, as well as those directly involved in clinical trials.
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.
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.
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