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Pharmaceutical Chemistry Journal

, Volume 51, Issue 7, pp 528–532 | Cite as

Determination of Cohort Size for Studies of Bioequivalence Using Computer Modeling

  • V. S. Arnautov
  • D. V. Reikhart
  • A. S. Borisov
Article
  • 33 Downloads

The randomized crossover (2 × 2) protocol is a standard design for studies of bioequivalence, reducing intraindividual variability. Determination of cohort size for studies of bioequivalence is an important element in planning studies and must be evidence-based. The aim of the present work was to produce and validate an algorithm for determining the required cohort size for studies of bioequivalence using computer simulation. The proposed algorithm is based on a procedure for assessing the power of the statistical test for known numbers of observations, variance, and preset values of acceptable first-order error levels.

Keywords

bioequivalence pharmacokinetics cohort size simulation 

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Copyright information

© Springer Science+Business Media, LLC 2017

Authors and Affiliations

  • V. S. Arnautov
    • 1
  • D. V. Reikhart
    • 2
  • A. S. Borisov
    • 1
  1. 1.Public Company Valenta FarmMoscowRussia
  2. 2.I. M. Sechenov First Moscow State Medical University, Russian Ministry of HealthMoscowRussia

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