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Biological evaluation of recombinant human erythropoietin in pharmaceutical products BJMBR
Ramos,A.S.; Schmidt,C.A.; Andrade,S.S.; Fronza,M.; Rafferty,B.; Dalmora,S.L..
The potencies of mammalian cell-derived recombinant human erythropoietin pharmaceutical preparations, from a total of five manufacturers, were assessed by in vivo bioassay using standardized protocols. Eight-week-old normocythemic mice received a single subcutaneous injection followed by blood sampling 96 h later or multiple daily injections with blood sampling 24 h after the last injection. Reticulocyte counting by microscopic examination was employed as the end-point using the brilliant cresyl blue or selective hemolysis methods, together with automated flow cytometry. Different injection schedules were investigated and dose-response curves for the European Pharmacopoeia Biological Reference Preparation of erythropoietin were compared. Manual and...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Recombinant human erythropoietin; Bioassay; Polycythemia; Reticulocyte counting; Normocythemic mice.
Ano: 2003 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-879X2003001100014
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