| Description |
1 online resource : text file, PDF |
| Contents |
Cover; Title; Copyright; Contents; Dedication; Foreword; Acknowledgements; Contributors; Chapter 1 . INTRODUCTION AND OVERVIEW OF SETTING UP STUDIES TO GOOD CLINICAL PRACTICE; Evaluation of Good Practices; Background to the Authors and the Chapters; Objective of Studies; Control of Studies; Regulation Versus Compliance; Study Conduct; Factors for Success; Conclusions; Chapter 2. INTERNATIONAL HARMONIZATION AND THE CONDUCT OF CLINICAL STUDIES TO SUPPORT THE APPROVAL OF NEW ANIMAL DRUGS: THE U.S. PERSPECTIVE; Regulatory Oversight; Noncompliance; VICH; Good Clinical Practices Draft Document |
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Related U.S. IssuesReferences; Chapter 3. THE ROLE OF THE INVESTIGATOR; Put It in the Protocol; Becoming a Complete Investigator; Conclusion; Appendix 3.1 Curriculum Vitae; Appendix 3.2 Informed Consent Form; Chapter 4. THE ROLE OF THE MONITOR; Pre-Study; During the Study; Post-Study; Chapter 5. QUALITY ASSURANCE ON VETERINARY CLINICAL TRIALS IN THE UNITED STATES; Background; What Is Quality Assurance?; The Benefits of Quality Assurance; The Responsibility for Quality and Where Quality Assurance Fits; Summary; References; Bibliography; Useful Addresses |
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Chapter 6. SETTING UP GCP TRIALS IN FISHThe Study Site; Protocol; Standard Operating Procedures; Study Design; Test Materials; Collection of Data; Collection and Examination of Samples; Trial Completion; Conclusion; Bibliography; Chapter 7. SETTING UP GCP TRIALS IN POULTRY; Protocol Development-Most Critical Phase of the Trial; Investigational New Drug Application and Notification for Pivotal Trials; Regulatory Agency Review of Protocol; Choosing the Trial Site; Trial Oversight by the Monitor, Investigator, Quality Control, and Quality Assurance; Paper and Electronic Data Capture |
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Poultry Trials-Special NeedsFINAL REPORT; References; Chapter 8. SETTING UP GCP TRIALS IN COMPANION ANIMALS; Permission; Protocol; Procedures; People; Partners, Premises and ""Paper; Protection; Precaution; Investigational Product; Pets; Conclusion; References; Chapter 9. SETTING UP GCP TRIALS IN PIGS; The Global Pig Industry; Planning and Organising GCP(V) Field Studies-The Responsibilities; Case Studies; Acknowledgements; References; Further Reading; Chapter 10. SETTING UP GCP TRIALS IN CALVES; Authorisation for Conduct of Study; Suitability of the Site; Test Substances |
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Transportation of CalvesSuitability of Animals; Planning and Design of Calf-Specific Studies; Monitoring of Studies; Acknowledgement; Bibliography; Appendix 10.1 Enrolment and Daily Clinical Record; Chapter 11. SETTING UP GCP TRIALS IN SHEEP; Factors Governing the Practical Design Implementation of GCP Clinical Trials in Sheep; Conclusion; Chapter 12. Setting Up GCP Trialsin Horses and Ponies; Sponsors and Monitors; Investigators; The Study Protocol; Summary; References; Chapter 13. GENETICALLY MODIFIED MICRO-ORGANISMS AND GCP STUDIES; Background; Commercial Aspects of Genetic Modification |
| Summary |
"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 studyControl of the studyConduct of the studyRegulation versus complianceFactors for successInternational harmonization activitiesRoles of the investigator, the monitor, and the practicing veterinarianSetting up GCP trials with particular animal speciesSOPs, the generic protocol, and the study reportContract research farms and multi-site studiesAuditing 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."--Provided by publisher |
| Bibliography |
Includes bibliographical references and index |
| Subject |
Veterinary medicine -- Research -- Methodology
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Veterinary medicine -- Research -- United States -- Methodology
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Clinical trials.
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Laboratory animals.
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Physiology.
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physiology.
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TECHNOLOGY & ENGINEERING -- Agriculture -- Animal Husbandry.
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Clinical trials
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Laboratory animals
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Physiology
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United States
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| Form |
Electronic book
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| Author |
Dent, N. J. (Nigel J.)
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Visanji, Ramzan
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Visanji, Ramzan, author
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| ISBN |
9781482294170 |
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1482294176 |
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9781420025958 |
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1420025953 |
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