13. Project Management and International Regulatory Requirements and Strategies for First-in-Human Trials

  1. Mitchell N. Cayen
  1. Carolyn D. Finkle1 and
  2. Judith Atkins2

Published Online: 3 AUG 2010

DOI: 10.1002/9780470613191.ch13

Early Drug Development

Early Drug Development

How to Cite

Finkle, C. D. and Atkins, J. (2010) Project Management and International Regulatory Requirements and Strategies for First-in-Human Trials, in Early Drug Development (ed M. N. Cayen), John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9780470613191.ch13

Editor Information

  1. Cayen Pharmaceutical Consulting, LLC, Bedminster, New Jersey, USA

Author Information

  1. 1

    MedImmune, Gaithersburg, Maryland, USA

  2. 2

    Paraxel International Inc., Waltham, Massachusetts, USA

Publication History

  1. Published Online: 3 AUG 2010
  2. Published Print: 23 JUL 2010

ISBN Information

Print ISBN: 9780470170861

Online ISBN: 9780470613191

SEARCH

Keywords:

  • project management and international regulatory requirements and strategies - for first-in-human trials;
  • product development initiation - with the end in mind;
  • IND submission in United States and global clinical trials

Summary

This chapter contains sections titled:

  • Introduction: Initiate Product Development with the End in Mind

  • Importance of Project Management

  • FDA Input Early and Often

  • IND Submission in the United States

  • Global Clinical Trials

  • Clinical Trial Applications

  • Conclusions

  • References