8. Validation of Mechanistic Models

  1. Kiyohiko Sugano

Published Online: 8 AUG 2012

DOI: 10.1002/9781118354339.ch8

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

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

How to Cite

Sugano, K. (2012) Validation of Mechanistic Models, in Biopharmaceutics Modeling and Simulations: Theory, Practice, Methods, and Applications, John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9781118354339.ch8

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:

  • validation of mechanistic models;
  • correlation between in vitro permeability and Peff;
  • free base and salts, and differences;
  • simulation model for free base;
  • biopharmaceutical modeling reliability

Summary

This chapter contains sections titled:

  • Concerns Related to Model Validation Using In Vivo Data

  • Strategy for Transparent and Robust Validation of Biopharmaceutical Modeling

  • Prediction Steps

  • Validation for Permeability-Limited Cases

  • Validation for Dissolution-Rate and Solubility-Permeability-Limited Cases (without the Stomach Effect)

  • Validation for Dissolution-Rate and Solubility-Permeability-Limited Cases (with the Stomach Effect)

  • Salts

  • Reliability of Biopharmaceutical Modeling

  • References