Chapter 9. Equivalence

  1. David Machin1,2,3,
  2. Michael J. Campbell3,
  3. Say Beng Tan4,5 and
  4. Sze Huey Tan2

Published Online: 30 JAN 2009

DOI: 10.1002/9781444300710.ch9

Sample Size Tables for Clinical Studies, Third Edition

Sample Size Tables for Clinical Studies, Third Edition

How to Cite

Machin, D., Campbell, M. J., Tan, S. B. and Tan, S. H. (2008) Equivalence, in Sample Size Tables for Clinical Studies, Third Edition, Wiley-Blackwell, Oxford, UK. doi: 10.1002/9781444300710.ch9

Author Information

  1. 1

    Children's Cancer and Leukaemia Group, University of Leicester, UK

  2. 2

    Division of Clinical Trials and Epidemiological Sciences, National Cancer Centre, Singapore

  3. 3

    Medical Statistics Unit, School of Health and Related Sciences, University of Sheffield, UK

  4. 4

    Singapore Clinical Research Institute, Singapore

  5. 5

    Duke–NUS Graduate Medical School, Singapore

Publication History

  1. Published Online: 30 JAN 2009
  2. Published Print: 21 NOV 2008

ISBN Information

Print ISBN: 9781405146500

Online ISBN: 9781444300710



  • bioequivalence concept at new therapy early development stage;
  • confidence interval (CI) for true difference;
  • associated hypotheses;
  • bioequivalence of different formulations of same drug;
  • Food and Drug Administration (FDA) recommendations;
  • anticipated mean values of Test and Reference formulations;
  • non-inferiority;
  • sample size paired differences;
  • sample sizes for bioequivalence studies—difference between two means or ratio of two means


This chapter contains sections titled:

  • Introduction

  • Theory and formulae

  • Bioequivalence

  • Non-inferiority

  • Bibliography

  • Examples and the use of tables

  • References