3. Genetic Toxicity Testing to Qualify Alerting Impurities

  1. Andrew Teasdale
  1. Mike O'Donovan

Published Online: 3 JAN 2011

DOI: 10.1002/9780470929377.ch3

Genotoxic Impurities

Genotoxic Impurities

How to Cite

O'Donovan, M. (2011) Genetic Toxicity Testing to Qualify Alerting Impurities, in Genotoxic Impurities (ed A. Teasdale), John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9780470929377.ch3

Editor Information

  1. AstraZeneca, Leicester, United Kingdom

Author Information

  1. AstraZeneca, Alderley Park, United Kingdom

Publication History

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

ISBN Information

Print ISBN: 9780470499191

Online ISBN: 9780470929377



  • genotoxic risk evaluation, from a preclinical perspective - genetic toxicity testing to qualify alerting impurities;
  • in vitro cytogenetics assays - in vitro chromosome aberration test (IVC), identifying agents causing structural chromosome aberrations in cultured mammalian cells;
  • in vivo genotoxicity tests - rodent bone marrow micronucleus test


This chapter contains sections titled:

  • Introduction

  • In Vitro Genotoxicity Tests

  • In Vivo Genotoxicity Tests

  • DNA Binding Assays

  • Test Performance

  • Test Strategy

  • Glossary

  • References