8. Toxicokinetics in Support of Drug Development

  1. Mitchell N. Cayen
  1. Gary Eichenbaum1,
  2. Vangala Subrahmanyam2 and
  3. Alfred P. Tonelli1

Published Online: 3 AUG 2010

DOI: 10.1002/9780470613191.ch8

Early Drug Development

Early Drug Development

How to Cite

Eichenbaum, G., Subrahmanyam, V. and Tonelli, A. P. (2010) Toxicokinetics in Support of Drug Development, in Early Drug Development (ed M. N. Cayen), John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9780470613191.ch8

Editor Information

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

Author Information

  1. 1

    Johnson & Johnson Pharmaceutical Research and Development, Raritan, New Jersey, USA

  2. 2

    Sai Advantium Pharma Ltd., Hinjewadi, Pune, India

Publication History

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

ISBN Information

Print ISBN: 9780470170861

Online ISBN: 9780470613191



  • toxicokinetics in support of drug development;
  • toxicokinetic parameter estimates and calculations;
  • toxicokinetic data interpretation


This chapter contains sections titled:

  • Introduction

  • Historical Perspectives

  • Regulatory Considerations

  • Factors to Consider in the Design of Toxicokinetic Studies

  • Toxicokinetic Parameter Estimates and Calculations

  • Interpretation of Toxicokinetic Data

  • Role of Toxicokinetics in Different Types of Toxicity Studies

  • Role of Toxicokinetics in Integrated Safety Assessment

  • Conclusions

  • References