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The Role of the Study Director in Nonclinical Studies

The Role of the Study Director in Nonclinical Studies Pharmaceuticals, Chemicals, Medical Devices, and Pesticides

Hardback (18 Jul 2014)

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Publisher's Synopsis

A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book:

  • Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study
  • Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models
  • Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years
  • Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry

Book information

ISBN: 9781118370391
Publisher: Wiley
Imprint: John Wiley & Sons, Inc.
Pub date:
DEWEY: 616.075
DEWEY edition: 23
Language: English
Number of pages: 560
Weight: 1566g
Height: 289mm
Width: 226mm
Spine width: 31mm