Chapter 9. Population and Individual Bioequivalence

  1. Dieter Hauschke1,
  2. Volker Steinijans1 and
  3. Iris Pigeot2

Published Online: 11 MAY 2007

DOI: 10.1002/9780470094778.ch9

Bioequivalence Studies in Drug Development: Methods and Applications

Bioequivalence Studies in Drug Development: Methods and Applications

How to Cite

Hauschke, D., Steinijans, V. and Pigeot, I. (2007) Population and Individual Bioequivalence, in Bioequivalence Studies in Drug Development: Methods and Applications, John Wiley & Sons, Ltd, Chichester, UK. doi: 10.1002/9780470094778.ch9

Author Information

  1. 1

    Department of Biometry, ALTANA Pharma, Germany

  2. 2

    Bremen Institute for Prevention Research and Social Medicine, University of Bremen, Germany

Publication History

  1. Published Online: 11 MAY 2007
  2. Published Print: 19 JAN 2007

ISBN Information

Print ISBN: 9780470094754

Online ISBN: 9780470094778

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Keywords:

  • average bioequivalence concept;
  • population bioequivalence (PBE);
  • population and individual bioequivalence;
  • study designs and statistical models;
  • TRTR / RTRT replicate design;
  • probability-based criteria and FDA;
  • scaled individual bioequivalence criterion;
  • structural equation model (SEM)

Summary

This chapter contains sections titled:

  • Introduction

  • Brief history

  • Study designs and statistical models

  • Population bioequivalence

  • Individual bioequivalence

  • Disaggregate criteria

  • Other approaches

  • Average bioequivalence in replicate designs

  • Example: The antihypertensive patch dataset

  • Conclusions

  • References