The Role of the Study Director in Nonclinical Studies

Pharmaceuticals, Chemicals, Medical Devices, and Pesticides

Nonfiction, Science & Nature, Science, Chemistry, Technical & Industrial, Health & Well Being, Medical, Medical Science, Pharmacology
Cover of the book The Role of the Study Director in Nonclinical Studies by Barbara Mounho, Lijie Fu, Wiley
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Author: Barbara Mounho, Lijie Fu ISBN: 9781118874080
Publisher: Wiley Publication: May 2, 2014
Imprint: Wiley Language: English
Author: Barbara Mounho, Lijie Fu
ISBN: 9781118874080
Publisher: Wiley
Publication: May 2, 2014
Imprint: Wiley
Language: English

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
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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:

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