Veterinary Clinical Trials From Concept to Completion

Nigel Dent, Ramzan Visanji (Autoren)

Buch | Hardcover

348 Seiten

2001
Crc Press Inc (Verlag)
978-1-57491-121-3 (ISBN)

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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.

Ramzan Visanji, Nigel Dent

Introduction and Overview of Setting Up Studies to Good Clinical Practice. International Harmonization and the Conduct of Clinical Studies to Support the Approval of New Animal Drugs: The U.S. Perspective. The Role of the Investigator. The Role of the Monitor. Quality Assurance on Veterinary Clinical Trials. Setting Up GCP Trials in Fish. Setting GCP Trials in Poultry. Setting Up GCP Trials in Companion Animals. Setting Up GCP Trials in Pigs. Setting Up GCP Trials in Calves. Setting Up GCP Trials in Sheep. Setting Up GCP Trials in Horses and Ponies. Genetically Modified Micro-Organisms and GCP Studies. Contract Research Farms and Their Involvement with GCP Studies. The Practicing Veterinarian's Role in Clinical Trials. Standard Operating Procedures. The Generic Protocol. How to Write the Final Study Report. Data, Statistical Analysis and Reporting for Veterinary Clinical Trials. Registration Submissions for Veterinary Medicines. Large-Scale Production of Ectoparasites for Use in Veterinary Trials. Auditing GCP Trials. Multisite Studies. Appendices. Index.

Erscheint lt. Verlag	31.12.2001
Verlagsort	Bosa Roca
Sprache	englisch
Maße	178 x 254 mm
Gewicht	907 g
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
	Naturwissenschaften ► Biologie ► Zoologie
	Technik
	Veterinärmedizin
	Weitere Fachgebiete ► Land- / Forstwirtschaft / Fischerei
ISBN-10	1-57491-121-X / 157491121X
ISBN-13	978-1-57491-121-3 / 9781574911213
Zustand	Neuware