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Systems, Abingdon, UK) was used to assess the EPO protein content.

When epoetin alfa is used in people scheduled for surgery, higher doses are used.

No studies presented a priori power calculations for patient number and study duration that would be required to demonstrate clinically significant survival differences for neoplastic diseases.

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Whereas ACD will improve with recovery from the chronic disorder, this is usually not possible, although the anemia will wax and wane with the activity of an associated inflammatory process, and may resolve altogether with successful treatment of an underlying infection.

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Allogeneic (as in allogeneic stem cell transplant) - with respect to CML, this term is usually used in reference to stem cell or bone marrow transplantation.

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The presence of silicon oil droplets allowed an efficient testing of the light obscuration, flow microscopy, and Coulter counter instruments.

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This work also demonstrates the potential utility of radar chart analysis to compare the profiles of aggregate and particle formation of varying size ranges and morphologies as measured by a variety of analytical methods, across different protein samples in analytical comparability assessments.

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For other malignancies, and in most other chronic diseases, there is insufficient evidence to show that measuring serum EPO levels alone is clinically useful for predicting treatment responses, and current guidelines do not recommend it because it is unlikely to guide clinical decision making.

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Cardiometabolic risk factors were marked, patients were asked about their medical history.

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Information on academic safety-related actions was obtained from review of internal unpublished documents of the coauthors and published material identified in EmBASE and MedLine (MeSH terms epoetin, pure red blood cell aplasia).

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Several clinical trials of Procrit were halted in November and December of 2003 after researchers discovered a higher-than-expected number of blood clots among patients using the medication.

Anticoagulants are widely used for preventing VTE in a broad range of surgical and medical patients.

Prevention of chemotherapy-related anemia by recombinant human erythropoietin (EPO) in patients with small cell lung cancer receiving cyclophosphamide, doxorubicin, and etoposide (CAE) chemotherapy with G-CSF support.

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In addition, few of the clinical evaluations were competitor controlled and studies were not thorough enough to show equivalent safety and efficacy of the biosimilar products to the innovator epoetin alfa.

Assessment of quality of life and hemoglobin values in breast-cancer patients treated with epoetin beta.

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In some instances there will be a need to compare certain adverse events of interest between the biosimilar and the reference product.

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Side effects of varying degrees of severity have been reported in patients taking EPO.

Because the results were not yet peer reviewed or published at the time the guidelines were finalized and were not blieved to alter the guideline statements, this study is not incorporated in this set of guidelines, but will provide data related to use of darbepoetin alfa in children.

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Erythropoietin might have its most important effects in certain tissue subsets.

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EPOGEN (epoetin) should be permanently discontinued in patients with antibody-mediated anemia.

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The determination of the percentage of hypochromic red cells or reticulocyte hemoglobin content can also be useful in detecting accompanying iron-restricted erythropoiesis in patients with anemia of chronic disease.

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Depending on the HLA genotype of the patient, a different set of peptides derived from the protein drug is presented to T cells that may result in activation of T cells in one patient, but not in another.

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Coagulation in studies and fistula blood flow during erythropoietin therapy in haemodialysis patients.

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All EPO samples were desalted and concentrated by a nanosep centrifugal device (Pall Life Sciences, Ann Arbor, USA) using the method described in the Ph.

When the hematocrit has returned to the desired range, therapy may be resumed.

For example, subtle differences in the conformational state of a recombinant protein product can be very difficult to detect even with state-of-the-art analytical techniques.

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The US Generic Pharmaceutical Association requests that biosimilars should share the same INN as the reference biological once comparability and interchangeability are shown.

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In 2010, PDMA approved a biosimilar epoetin, although its indication does not include oncology; no oncology biosimilar has yet received PDMA approval.

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