Chapter 3. Use of Hepatocytes for Characterizing a Candidate Drug's Metabolism and Drug Interaction Potential

  1. Saura C. Sahu
  1. Srikanth C. Nallani1,
  2. John M. Strong2 and
  3. Shiew Mei Huang3

Published Online: 27 FEB 2008

DOI: 10.1002/9780470516751.ch3

Hepatotoxicity

Hepatotoxicity

How to Cite

Nallani, S. C., Strong, J. M. and Huang, S. M. (2007) Use of Hepatocytes for Characterizing a Candidate Drug's Metabolism and Drug Interaction Potential, in Hepatotoxicity (ed S. C. Sahu), John Wiley & Sons, Ltd, Chichester, UK. doi: 10.1002/9780470516751.ch3

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

    Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, WO21, HFD-870, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA

  2. 2

    Laboratory of Clinical Pharmacology, Office of Testing and Research, Food and Drug Administration, WO64, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA

  3. 3

    Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, Food and Drug Administration, WO21, HFD-850, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA

Publication History

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

ISBN Information

Print ISBN: 9780470057162

Online ISBN: 9780470516751

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Keywords:

  • clinical marketing approaches;
  • drug-metabolizing enzymes;
  • drug–drug interactions;
  • drugs hepatotoxic potential;
  • reactive metabolite and drug-metabolizing capacity;
  • cross species safety assessments;
  • human-derived tissues;
  • drug development process;
  • drug-candidate development;
  • microsomes / post-mitochondrial fractions

Summary

This chapter contains sections titled:

  • Introduction

  • Metabolic Pathway Identification in Animals and Humans in vitro

  • Characterizing a Candidate Drug's Metabolic Pathways Using Human Hepatocytes

  • Prediction of in vivo Clearance of Candidate Drugs

  • Characterizing Drug Metabolizing Enzyme Iinduction-Potential of Candidate Drug

  • Bioactivation of Drugs to Reactive Metabolites

  • Identification of Reactive Metabolites

  • Conclusions

  • References