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Biological evaluation of recombinant human erythropoietin in pharmaceutical products

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Academic year: 2019

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Table 1. Example of the single injection assay showing reticulocyte numbers and coefficient of variation (CV) after the administration of 30 IU/0.5 ml per mouse of the European Pharmacopoeia Biological Reference Preparation of recombinant human erythropoie
Table 2. Comparison of combined potencies and assay precision (weight) after bioassay (N = 3) of six commercial recombinant human erythropoietin samples using the brilliant cresyl blue (BCB), selective hemolysis (SH) and flow cytometry (FC) reticulocyte co
Table 3. Percentage of reticulocytes and coefficients of variation (CV) after a single injection of 30 IU/0.5 ml per mouse of the European Pharmacopoeia Biological Reference Preparation of recombinant human erythropoietin using different blood sampling pro
Table 5. Comparison of potencies and assay precision after bioassay of six recombinant human erythropoietin pharmaceutical products using single injection or multiple injection protocols, with reticulocytes counted by the flow cytometry method.

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