26. Regulatory Considerations in Metabolism- and Transporter-Based Drug Interactions

  1. Ming Hu4 and
  2. Xiaoling Li5
  1. Yuanchao (Derek) Zhang1,†,
  2. Lei Zhang1,†,
  3. John M. Strong2 and
  4. Shiew-Mei Huang1

Published Online: 5 JUL 2011

DOI: 10.1002/9781118067598.ch26

Oral Bioavailability: Basic Principles, Advanced Concepts, and Applications

Oral Bioavailability: Basic Principles, Advanced Concepts, and Applications

How to Cite

Zhang, Y., Zhang, L., Strong, J. M. and Huang, S.-M. (2011) Regulatory Considerations in Metabolism- and Transporter-Based Drug Interactions, in Oral Bioavailability: Basic Principles, Advanced Concepts, and Applications (eds M. Hu and X. Li), John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9781118067598.ch26

Editor Information

  1. 4

    Department of Pharmacological and Pharmaceutical Sciences, College of Pharmacy, University of Houston, 1441 Moursund Street, Houston, TX 77030, USA

  2. 5

    Department of Pharmaceutics and Medicinal Chemistry, Thomas J. Long School of Pharmacy and Health Sciences, University of the Pacific, Stockton, CA 95211, USA

Author Information

  1. 1

    Offices of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Building 51, Room 3106 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA

  2. 2

    Offices of Pharmaceutical Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Building 51, Room 3106 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA

  1. Frontage Laboratories, Inc., Exton, PA 19341, USA

Publication History

  1. Published Online: 5 JUL 2011
  2. Published Print: 15 AUG 2011

Book Series:

  1. Wiley Series in Drug Discovery and Development

Book Series Editors:

  1. Binghe Wang

ISBN Information

Print ISBN: 9780470260999

Online ISBN: 9781118067598

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Keywords:

  • metabolism- and transporter-based drug interactions, regulatory considerations - sites of action;
  • drug interaction potential, NME evaluation - regulatory review, prior to market approval;
  • drug transporter function perturbations - drug interactions, altering drug pharmacokinetics

Summary

This chapter contains sections titled:

  • Overview of drug–drug interactions

  • Regulatory requirements of drug–drug interaction studies

  • Highlights of a draft guidance for industry: drug interaction studies—study design, data analysis, and implications for dosing and labeling (2006)

  • A recent labeling example to illustrate the translation of complicated drug interaction results to labeling: tipranavir

  • Summary

  • Acknowledgment

  • Abbreviations

  • References