Veterinary Clinical Trials From Concept to Completion

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A01=Nigel Dent
A01=Ramzan Visanji
ADAS
advanced veterinary drug approval process
animal
Animal Drugs
Animal Health Industry
Animal Health Products
Animal Studies
Animal's Welfare
Associate Investigators
Author_Nigel Dent
Author_Ramzan Visanji
Category=P
companion animal studies
contract
contract research organizations
enquiry
eq_isMigrated=1
eq_isMigrated=2
eq_nobargain
experimental design methods
FDA 1999a
Final Study Report
Fish Vaccines
GCP Compliance
GCP Require
GCP Trial
good
health
industry
Internal Sop
international regulatory standards
Investigational Product
laboratory
medicine
Multisite Studies
organisation
practice
quality assurance procedures
Raw Data
Regulatory Reviewer
Site Selection
statistical analysis techniques
Statistical Test
Study Notebook
Trial Site
Unique Study Number
Veterinary Clinical Trials
Veterinary Medicinal Products

Product details

  • ISBN 9781574911213
  • Weight: 907g
  • Dimensions: 178 x 254mm
  • Publication Date: 31 Dec 2001
  • Publisher: Taylor & Francis Inc
  • Publication City/Country: US
  • Product Form: Hardback
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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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