6. Human Genotoxic Metabolites: Identification and Risk Management

  1. Andrew Teasdale
  1. Krista Dobo1,
  2. Don Walker2 and
  3. Andrew Teasdale3

Published Online: 3 JAN 2011

DOI: 10.1002/9780470929377.ch6

Genotoxic Impurities

Genotoxic Impurities

How to Cite

Dobo, K., Walker, D. and Teasdale, A. (2011) Human Genotoxic Metabolites: Identification and Risk Management, in Genotoxic Impurities (ed A. Teasdale), John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9780470929377.ch6

Editor Information

  1. AstraZeneca, Leicester, United Kingdom

Author Information

  1. 1

    Pfizer, Groton, CT, USA

  2. 2

    ex. Pfizer, Sandwich, Kent, United Kingdom

  3. 3

    AstraZeneca, Leicester, United Kingdom

Publication History

  1. Published Online: 3 JAN 2011
  2. Published Print: 14 FEB 2011

ISBN Information

Print ISBN: 9780470499191

Online ISBN: 9780470929377



  • human genotoxic metabolites - identification and risk management, complex issue of how to assess potential presence and risk posed by genotoxic metabolites;
  • genotoxic metabolites - discovered in early clinical development;
  • conduct of genotoxicity testing - for drug synthesis intermediates, complying with worker safety and transportation regulations


This chapter contains sections titled:

  • Introduction

  • Predicting Human Metabolites

  • Genotoxic Metabolites Discovered in Early Clinical Development

  • Genotoxic Metabolites Discovered in Late Clinical Development

  • References