Chapter 23. Hepatotoxicity in Oncology Drug Development

  1. Saura C. Sahu
  1. Wei Chen1,
  2. Kenneth Hastings2 and
  3. John K. Leighton1

Published Online: 27 FEB 2008

DOI: 10.1002/9780470516751.ch23



How to Cite

Chen, W., Hastings, K. and Leighton, J. K. (2007) Hepatotoxicity in Oncology Drug Development, in Hepatotoxicity (ed S. C. Sahu), John Wiley & Sons, Ltd, Chichester, UK. doi: 10.1002/9780470516751.ch23

Editor Information

  1. Division of Toxicology, Office of Toxicology, Office of Applied Research and Safety Assessment, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, 8301 Muirkirk Road, Laurel, MD 20708, USA

Author Information

  1. 1

    Division of Drug Oncology Products, Office of Oncology Drug Products, US Food and Drugs Administration, FDA/CDER/OODP/DDOP, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA

  2. 2

    Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, USA

  1. Disclaimer: The views expressed in this article are those of the authors and do not necessarily reflect the views of the U.S. Food and Drug Administration.

Publication History

  1. Published Online: 27 FEB 2008
  2. Published Print: 14 DEC 2007

ISBN Information

Print ISBN: 9780470057162

Online ISBN: 9780470516751



  • cellular targets and biological molecules Diversity;
  • drug induced liver injury (DILI);
  • non-steroidal anti-inflammatory drugs (NSAID);
  • neuropsychotropic medications;
  • postmarketing evaluations;
  • antineoplastic drugs;
  • dose-limiting toxicity;
  • dose-dependent hepatotoxicity;
  • Adverse drug reactions (ADR);
  • immunogenic neoantigens


This chapter contains sections titled:

  • Introduction

  • Mechanism of Hepatic Adverse Drug Reactions

  • Mechanisms: Case Studies

  • Current in Vitro Methodologies used for Safety Assessment of Hepatotoxicity

  • In vivo Studies and Regulatory Considerations

  • Promises and Limitations of New Technologies for Liver Toxicity Assessment

  • Conclusions

  • References