The Role of the Study Director in Nonclinical Studies

The Role of the Study Director in Nonclinical Studies

Editor(s): William J. Brock, Barbara Mounho, Lijie Fu

Published Online: 9 MAY 2014 08:40PM EST

Print ISBN: 9781118370391

Online ISBN: 9781118873922

DOI: 10.1002/9781118873922

About this Book

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

Table of contents

    1. You have free access to this content
    2. Chapter 13

      Clinical Pathology (pages 225–243)

      Niraj K. Tripathi, Lila Ramaiah and Nancy E. Everds

    3. Chapter 19

      Genetic Toxicology Studies (pages 333–354)

      Robert R. Young, Mark Powley, Timothy E. Lawlor and Marilyn J. Aardema

    4. Chapter 25

      Vaccines: Preventive and Therapeutic Product Studies (pages 439–463)

      Deborah L. Novicki, Jayanthi J. Wolf, Lisa M. Plitnick and Melanie Hartsough

    5. Chapter 28

      Lessons from the Front Lines (pages 505–518)

      Christopher P. Chengelis and C. Steven Godin

    6. You have free access to this content
    7. You have free access to this content