Statistical Analysis of Results from the Attestation of Biological Standard Samples: Use of the Mann-Whitney Test
- Authors: Fadeikina O.V.1, Volkova R.A.1, Karpova E.V.1
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Affiliations:
- Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
- Issue: Vol 53, No 7 (2019)
- Pages: 655-659
- Section: Structure of Chemical Compounds, Methods of Analysis and Process Control
- URL: https://ogarev-online.ru/0091-150X/article/view/245931
- DOI: https://doi.org/10.1007/s11094-019-02057-1
- ID: 245931
Cite item
Abstract
An algorithm for assessing the possibility of joining two datasets obtained by different operators for attestation of standard samples of biological medicinal substances (SS BMS) is proposed. These studies tested the uniformity of the results obtained by different operators during attestation of industrial standard samples of the specific activity of an oral poliomyelitis vaccine, i.e., divalent live attenuated types 1 and 3 “BiVak polio” vaccine, using the Mann-Whitney and Z statistics for independent sets run manually using a formula, with subsequent interpretation of the results. Results from calculation of the Mann-Whitney test in Statistica software (version 10) are presented.
About the authors
O. V. Fadeikina
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Author for correspondence.
Email: fadeikina@expmed.ru
Russian Federation, Building 2, 8 Petrovskii Boulevard, Moscow, 127051
R. A. Volkova
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Email: fadeikina@expmed.ru
Russian Federation, Building 2, 8 Petrovskii Boulevard, Moscow, 127051
E. V. Karpova
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Email: fadeikina@expmed.ru
Russian Federation, Building 2, 8 Petrovskii Boulevard, Moscow, 127051
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