Determination of Cohort Size for Studies of Bioequivalence Using Computer Modeling
- 作者: Arnautov V.1, Reikhart D.2, Borisov A.1
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隶属关系:
- Public Company Valenta Farm
- I. M. Sechenov First Moscow State Medical University, Russian Ministry of Health
- 期: 卷 51, 编号 7 (2017)
- 页面: 528-532
- 栏目: Article
- URL: https://journals.rcsi.science/0091-150X/article/view/244694
- DOI: https://doi.org/10.1007/s11094-017-1648-6
- ID: 244694
如何引用文章
详细
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.
作者简介
V. Arnautov
Public Company Valenta Farm
Email: chem@folium.ru
俄罗斯联邦, Moscow
D. Reikhart
I. M. Sechenov First Moscow State Medical University, Russian Ministry of Health
Email: chem@folium.ru
俄罗斯联邦, Moscow
A. Borisov
Public Company Valenta Farm
Email: chem@folium.ru
俄罗斯联邦, Moscow