38 Métodos para la evaluación... without radioisotopes for recombinant human erythropoietins. Biologicals 1992; 20: 243-251. [34] Barbone AG, Aparicio B, Anderson DW, Natarajan J, Ritchie DM. Reticulocyte measurements as a bioassay for erythropoietin. Journal of Pharmaceutical and Biomedical Analysis 1994;12:515-522. [35] Storring PL, Gaines Das RE. The international standard for recombinant DNA-derived erythropoietin: collaborative study of four recombinant DNA-derived erythropoietins and two highly purified human urinary erythropoietins. Journal of Endocrinology 1992. 134: 459-484. [36] Ramos AS, Schmidt CA, Andrade SS, Fronza M, Rafferty B, Dalmora SL. Biological evaluation of recombinant human erythropoietin in pharmaceutical products. Brazilian Journal of Medical and Biological Research 2003; 36:1561- 1569. [37] Committee for Standardization of Biologics of the People’s Republic of China. Requirements for Biologics. Requirements for Recombinant Human Erythropoietin. 2000 [38] Heilmeyer L, Westhauser R. Reifungsstadien an uberlebenden reticulocyten in vitro und ihre bedutung fur die schatzung der hamoglobinproduktion in vivo. Ztsch Kline Med 1932; 121:361-379. [39] Lohmann RC, Crawford LN, Wood DE. Proficiency testing in reticulocyte counting. Clinical and Laboratory Haematology 1994; 16: 57-64. [40] Brugnara C. Use of reticulocyte cellular indices in the diagnosis and treatment of hematological disorders. International Journal of Clinical and Laboratory Research 1998; 28: 1-11. [41] Rudensky B. Comparison of a semi-automated new coulter methylene blue method with fluorescence flow cytometry in reticulocyte counting. Scandinavian Journal of Clinical and Laboratory Investigation 1997; 57: 291-296. [42] Chang CC, Kass L. Clinical significance of immature reticulocyte fraction determined by automated reticulocyte counting. American Journal of Clinical Pathology 1997; 108:69-73. [43] National Commitee for Clinical Laboratory Standards. Proposed Standard: Method for reticulocyte counting (H16-P). Villanova PA: The National Committee for Clinical Laboratory Standards. [44] Savage R, Skoog D, Rabinovich A..Analytical inaccuracy and imprecision in reticulocyte counting: A preliminary report from the College of American Pathologist Reticulocyte Project. Blood Cells 1985; 11:97-112. [45] Peebles DA, Hochberg A, Clark TD. Analysis of manual reticulocyte counting. Am J Clin Path 1981; 76: 713-717. [46] Miale J. Laboratory Medicine Hematology 5 th ed. St Louis: C.V. Mosby,Co 1977. [47] Tanke HJ, Nieuwenhuis IAB, Koper GJM, Slats JCM, Ploem JS. Flow cytometry of human reticulocytes based on RNA fluorescence. Cytometry 1980; 5:313-320. [48] Chin-Yee I, FRCP(C) MD, Keeney M, Filmls Art, Lohmann C. Flow cytometric reticulocyte analysis using thiazole orange; clinical experience and technical limitations. Clin lab Haemat 1991; 13: 177-188 [49] Seligman PA, Allen RH, Kirchanski SJ, Natale PJ. Automated analyses of reticulocytes using fluorescent staining with both acridine orange and an immunofluorescence technique. Am J Hematol 1983; 14:57. [50] Sage BH, O’Conell JP, Mercolino TJ. A rapid vital staining procedure for flow cytometric analysis of human reticulocytes. Cytometry 1983; 4:222-227. [51] Lee L, Chen C, Chiu L. Thiazole Orange: A new dye for reticulocyte analysis. Cytometry 1986; 7:508. [52] Ferguson D, Lee S-E, Gordon P. Evaluation of reticulocyte counts by flow cytometry in a routine laboratory. Am J Hematol 1990; 33:13- 17. [53] Kitamura T, Tojo A, Kuwaki T, Chiba S, Miyazono K, Urabe A, et al. Identification and analysis of human erythropoietin receptors on a factor-dependent cell line. Blood 1989; 73: 375- 380. [54] Wen D, Boissel J, Showers M, Ruch BC, Bunn HF. Erythropoietin structure-function relationships. Journal of Biological Chemistry 1994, 269: 22839-22846. [55] Miyazaki Y, Kuryama K, Higuchi H, Sohda H, Imai N, Saito M, et al. Establishment and characterization of a new erythropoietindependent acute myeloid leukaemia cell line, AS-E2. Leukemia 1997, 11: 1941-1949. [56] Qiu H, Belanger A, Yoon HP, Bunn HF. Homodimerization restores biological activity to an inactive erythropoietin mutant. Journal of Biological Chemistry 1998, 273: 11173-11176. [57] Hammerling Ulf, Kroon R, Wilhelmsen T, Sjodin L. In vitro bioassay for human erythropoietin based on proliferative stimulation of an eythroid cell line and analysis of carbohydrate-dependent. Journal of Pharmaceutical Biomed Analysis 1996; 14: 1455-1469. [58] Hermentin P, Witzel R, Schwick-Wagner P, Blumrich M. N-Glycan Charge Assay-an
Métodos para la evaluación... 39 Alternative for Potency Assays of Therapeutic Glycoproteins? Dev Biol Basel Karger 2002; 111:89-97. [59] Hermentin P, Witzel R, Kansy EJ, Diderrich G, Hoffmann D, Metzner H, et al. The hypothetical N-glycan charge: a number that characterizes protein glycosylation. Glycobiology 1996; 6:217-230. [60] Hermentin P, Witzel R. The hypothetical N- glycan charge: A number to characterize protein N-glycosylation. Pharm Pharmacol Commun 1999; 5:33-43. [61] Hermentin P, Witzel R, Vliegenthart JFG, Kamerling JP, Nimtz M, Conradt HS. A strategy for the mapping of N-glycans by high-pH anionexchange chromatography with pulsed amperometric detection. Anal Biochem 1992; 203:281-289. Recibido: 10 de septiembre de 2004 Aceptado: 20 de diciembre de 2004
Change language