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Article
Statistical Analysis of Results from the Attestation of Biological Standard Samples: Use of the Mann-Whitney Test
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 tes...
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Article
Development of an Industrial Reference Sample for the Specific Activity of Erythropoietin
On the basis of WHO recommendations and the principles developed for the standardization of erythropoietins we selected one epoetin alfa pharmaceutical substances included in the State Register of Medicines as...
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Article
Elaboration of Certification Procedures for Reference Standards of Biological Drugs
Reference standards (RSs) are necessary to standardize medicinal products, including biological drugs, and are key factors of their efficacy and safety. Experience in certification of biological RSs and an ana...
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Article
Certification of Human Immunoglobulin Standard Samples for Determination of Anticomplementary Activity
An evaluation and stability study of the original Russian human immunoglobulin standard intended for determining the anticomplementary activity and assessing the stability and acceptability of test results are...
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Article
Method Validation for Anticomplementary Activity of Human Immunoglobulin Drugs
Amethod for determining anticomplementary activity of human immunoglobulin (Ig) preparations for i.v. administration by complement fixation test was validated for accuracy, precision (repeatability, intralabor...
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Article
Pharmacopeia Standard Samples and Their Practical Application in the National Drug Standardization System
Standard samples constitute one of the key elements in the medicines standardization system. In pharmacopeia analysis in the Russian Federation and many foreign countries, the use of standard samples is regula...
