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Autoantibodies to erythropoietin receptor in patients with immune-mediated diseases: relationship to anaemia with erythroid hypoplasia.
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Conversely, if different active sites of the biotherapeutic or different receptors of the target cells are involved in different therapeutic indications, or if the historical safety profile of the reference product differs qualitatively between the different therapeutic indications, additional data may need to be generated to justify the extrapolation of safety and efficacy data.
The use of an IgG 4 or IgG 2 isotype or use of an antibody containing mutations in the Fc region that minimize receptor binding and effector function would likely reduce the infusion reactions and cytokine release syndromes seen with a number of the licensed mAbs (mainly IgG 1).
Commenters also frequently speculated on the effect of the proposed decision on the need for transfusions and the adequacy of the blood supply to meet higher demands.
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It accounts for up to 30% of all cases of nonischemic cardiomyopathy and may not necessarily correlate with the amount of alcohol consumed.
Borovnica pokazuje i niz drugih pozitivnih, svojstava, posebno kao dijetalno sredstvo kod akutnih i hronicnih oboljenja zeluca i zelucano-crijevnog trakta.
This was a Phase 3, parallel-group, randomized, multicenter, open-label, active-controlled study of women with epithelial ovarian carcinoma whose disease did not respond to or recurred after treatment with first-line chemotherapy with a platinum-based regimen.
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Sensitivity analysis for the prevalence of CKD was also performed using the Cockcroft-Gault (CG) equation to generate an estimate of creatinine clearance.
Red cell distribution width is associated with long-term prognosis in patients with stable coronary artery disease.
During follow up, 24.
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Assessment of immunogenicity, therefore, already starts during the quality assessment of the biosimilar, where the physicochemical characteristics of the biosimilar and the reference product are extensively assayed, assessed and compared.
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Data were selected for analysis using an evidence hierarchy and quantitatively analyzed to assess statistical homogeneity.
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However, testing for only one indication may not be sufficient to adequately explore the immunogenic potential of a biosimilar drug throughout several indications.
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The erythropoietin then travels to the bone marrow via the blood circulation where it activates new red blood production.
The effects of normal as compared with low hematocrit values in patients with cardiac disease who are receiving hemodialysis and epoetin.
Study 4 was an open-label study conducted in Europe and Australia in which 347 patients were randomized to treatment with Aranesp รค and 175 patients were randomized to continue on Epoetin alfa or Epoetin beta.
The level of immunogenicity can be markedly different for products considered to be very similar.
Ostarjeli eritrociti razlazu se u retikuloendotelnom sistemu prvenstveno slezene, kostanoj srzi i Kupfferovim elijama jetre, kao i drugim organima.
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Pure red cell aplasia (PRCA), a disorder first characterized in 1922 (), is a syndrome characterized by severe normochromic, normocytic anaemia associated with reticulocytopenia and absence of erythroblasts from an otherwise normal bone marrow.
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These weak interactions have a major role in the overall conformation and conformational dynamics of all proteins.
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