Statistical Analysis of Results from the Attestation of Biological Standard Samples: Use of the Mann-Whitney Test


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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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