Determination of Cohort Size for Studies of Bioequivalence Using Computer Modeling
- Authors: Arnautov V.S.1, Reikhart D.V.2, Borisov A.S.1
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Affiliations:
- Public Company Valenta Farm
- I. M. Sechenov First Moscow State Medical University, Russian Ministry of Health
- Issue: Vol 51, No 7 (2017)
- Pages: 528-532
- Section: Article
- URL: https://journals.rcsi.science/0091-150X/article/view/244694
- DOI: https://doi.org/10.1007/s11094-017-1648-6
- ID: 244694
Cite item
Abstract
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
About the authors
V. S. Arnautov
Public Company Valenta Farm
Email: chem@folium.ru
Russian Federation, Moscow
D. V. Reikhart
I. M. Sechenov First Moscow State Medical University, Russian Ministry of Health
Email: chem@folium.ru
Russian Federation, Moscow
A. S. Borisov
Public Company Valenta Farm
Email: chem@folium.ru
Russian Federation, Moscow