Chapter 4. Human-Based in vitro Experimental Systems for the Evaluation of Human Drug Safety

  1. Saura C. Sahu
  1. Albert P. Li

Published Online: 27 FEB 2008

DOI: 10.1002/9780470516751.ch4



How to Cite

Li, A. P. (2007) Human-Based in vitro Experimental Systems for the Evaluation of Human Drug Safety, in Hepatotoxicity (ed S. C. Sahu), John Wiley & Sons, Ltd, Chichester, UK. doi: 10.1002/9780470516751.ch4

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. The ADMET Group LLC, In vitro ADMET Laboratories LLC and Advanced Pharmaceutical Sciences Inc., 15235 Shady Grove Road, Suite 303, Rockville, MD 20850, USA

Publication History

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

ISBN Information

Print ISBN: 9780470057162

Online ISBN: 9780470516751



  • rat and human liver microsomes;
  • metabolism species–species differences;
  • human metabolite and toxic metabolite;
  • human drug toxicity;
  • human–nonhuman animal differences;
  • human-based experimental systems;
  • human drug metabolism enzymes;
  • Cell-based systems;
  • renal proximal tubule cells;
  • Long-term treatments


This chapter contains sections titled:

  • Accurate Assessment of Drug Safety as a Major Challenge to the Pharmaceutical Industry

  • Human-Specific Drug Toxicity as a Major Reason for the Failure of Prediction of Human Drug Toxicity with Preclinical Nonhuman Animal Models

  • Overcoming Species–Species Differences as an Approach to Better Predict Human Drug Toxicity

  • Overcoming the Major Deficiencies of an in vitro System

  • Conclusions

  • References