9. Bioequivalence and Biopharmaceutical Classification System

  1. Kiyohiko Sugano

Published Online: 8 AUG 2012

DOI: 10.1002/9781118354339.ch9

Biopharmaceutics Modeling and Simulations: Theory, Practice, Methods, and Applications

Biopharmaceutics Modeling and Simulations: Theory, Practice, Methods, and Applications

How to Cite

Sugano, K. (2012) Bioequivalence and Biopharmaceutical Classification System, in Biopharmaceutics Modeling and Simulations: Theory, Practice, Methods, and Applications, John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9781118354339.ch9

Author Information

  1. Asahi Kasei Pharma Corp., Shizuoka, Japan

Publication History

  1. Published Online: 8 AUG 2012
  2. Published Print: 20 AUG 2012

ISBN Information

Print ISBN: 9781118028681

Online ISBN: 9781118354339

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Keywords:

  • regulatory biowaiver scheme and BCS;
  • congruent condition of bioequivalence;
  • biowaiver scheme, possible extension;
  • summary for regulatory BCS biowaiver scheme;
  • point-to-point IVIVC

Summary

This chapter contains sections titled:

  • Bioequivalence

  • The History of BCS

  • Regulatory Biowaiver Scheme and BCS

  • Exploratory BCS

  • In VitroIn Vivo Correlation

  • References