14. First-in-Human Regulatory Submissions

  1. Mitchell N. Cayen
  1. Mary M. Sommer1,
  2. Mark Ammann2,
  3. Ulf B. Hillgren1,
  4. Kathleen J. Kovacs1 and
  5. Keith Wilner3

Published Online: 3 AUG 2010

DOI: 10.1002/9780470613191.ch14

Early Drug Development

Early Drug Development

How to Cite

Sommer, M. M., Ammann, M., Hillgren, U. B., Kovacs, K. J. and Wilner, K. (2010) First-in-Human Regulatory Submissions, in Early Drug Development (ed M. N. Cayen), John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9780470613191.ch14

Editor Information

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

Author Information

  1. 1

    Pfizer Global Research and Development, Groton, Connecticut, USA

  2. 2

    United BioSource Corporation, Ann Arbor, Michigan, USA

  3. 3

    Pfizer Global Research and Development, La Jolla, California, USA

Publication History

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

ISBN Information

Print ISBN: 9780470170861

Online ISBN: 9780470613191



  • first-in-human regulatory submissions - submission strategies;
  • Japan, clinical trial protocol notification;
  • European Union - clinical trial application


This chapter contains sections titled:

  • Introduction

  • Submission Strategies

  • First-in-Human Dossiers

  • United States: Investigational New Drug Application

  • European Union: Clinical Trial Application

  • Japan: Clinical Trial Protocol Notification

  • Emerging Regions

  • Biopharmaceuticals

  • Final Considerations