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Studies in the cancer setting include three randomized controlled trials; in patients with solid tumors receiving platinum-based chemotherapy, in patients with either solid tumors or hematological malignancies receiving non-platinum based chemotherapy, and in patients with hematological malignancies undergoing antineoplastic therapy.
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FDA-approved labels for ESAs available in the United States comprised additional data sources for this evidence review, in particular, recommended dosing information for the different clinical settings covered.
The alleged misrepresentations include: (1) Defendant Morrow's statements regarding the 2004 ODAC Meeting, (2) statements regarding the safety of Amgen's ESA products; and (3) statements about future growth.
Druga vrsta diskinezije javlja se kod onih kojima je zucna kesica operativno uklonjena, pa dolazi do premeaja u praznjenju zucnih kanala.
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See Note 7, Related party transactions, to the Consolidated Financial Statements.
Other means for measuring stability can be used and are well known to persons of skill in the art.
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Antonio Giulivi, Agnes Klein, and Supriya Sharma of Health Canada; Drs.
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The differences in isoform profiles between the tested EPO products represent distinct glycosylation, which likely originated from different cell lines used to produce the protein.
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The network meta-analysis did not allow conclusions on the comparative efficacy of different agents in preventing blood transfusions.
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In 2002, health authorities in France, Germany, Italy, Spain, and the United Kingdom concluded that the subcutaneous administration of Eprex should be considered contraindicated for treatment of anemia in patients with chronic kidney disease and mandated the intravenous administration of Eprex, which was thought to be less likely than subcutaneous administration to evoke an immune response.
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In: Aplastic Anaemia: Current Perspectives on the Pathogenesis and Treatment (ed.
Custom Manufacturing companies in the narrower sense are active in process scale up, pilot plant (trial) production, industrial-scale exclusive and non-exclusive manufacture and marketing.
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To understand the role of nanosized recombinant human erythropoietin (rhEPO) in wound healing, we investigated the effects of subcutaneous injections of EPO on skin regeneration after deep second-degree scalding injuries.
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This hypothesis is supported by results of a meta-analysis of randomised controlled trials that reported a trend towards increased survival in patients treated with erythropoietic agents ().
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Patients with compromised cardiac function and other chronic diseases, however, may have more exaggerated anemia-related symptoms.
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First, Abs production can be transient.
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When adjusting therapy, consider Hgb rate of rise, rate of decline, ESA responsiveness, and Hgb variability.
Such combinations may generally produce reduced side-effects as compared to combinations involving multiple pharmaceutical drugs (polypharmacy).
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Im November 2010 fanden Anhörungen vor der FDA statt.
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Sanjay Aher (SA) and Arne Ohlsson (AO) contributed equally to all sections of the protocol for this review.
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Za drogu se prikupljaju plodovi koji se suse u susnicama (Fractus Myrtilli) kao listovi koji se prikupljaju dok biljka cvjeta (Folium Myrtilli).
ESA-treated patients) reported that mortality was similar between the 2 groups (10% vs 11%, respectively).
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Patients randomized in treatment group (A) received four injections of EPO-beta (30.
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Verification of the similarity of biosimilars to innovator biopharmaceuticals remains a key challenge.
Neither early nor late administration of EPO is recommended.
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This kinetic classification is a useful first approach for any type of cytopenia.
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Untreated Patients with Diffuse Large Cell Lymphoma).
Because a limited amount of EPO products was available, we were restricted to the common assays used for quality control: high performance size exclusion chromatography (HP-SEC) to assess monomer and aggregate content, ELISA to determine EPO protein content, SDS-PAGE under non-reducing conditions to detect possible fragmentation and covalent protein aggregates, capillary zone electrophoresis (CZE) for isoform profiling and a normocythemic mouse assay to test for potency.
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The Urgent Placement Scheme was started in September to accept kidney patients, who needed treatment immediately, at highly subsidised fees, while their application to join the NKF programme was being processed.
On the business side, product innovation must proceed at a more rapid pace, because life cycles of fine chemicals are shorter than those of commodities.
Even though the amino acid sequence of Humulin occurs naturally in humans, FDA reviewers chose to consider it, for purposes of approval, as a new molecular entity (NME).
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The disorder is caused by neutralizing anti-EPO Abs.
Researchers from the University of Wisconsin (USA) claim that it acts on the central nervous system and causes the formation of clots in blood vessels.
Safe and Easy Introduction of Darbepoetin-Alpha in Patients Receiving Maintenance Hemodialysis and Epoetin Monotherapy: A “Half-and-Half” Combination Therapy.
The complex high-molecular-weight three-dimensional structures of biopharmaceuticals, their heterogeneity and dependence on production in living cells makes them different from classical chemical drugs.
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As used herein, the term “pharmaceutical agent or drug” as used herein refers to a chemical compound or composition capable of inducing a desired therapeutic effect when properly administered to a patient.
The act of determining whether a composition or formulation modulates disease or condition related activity at the tissue, organ or organismal level further includes measuring the parameters by which the disease or condition is defined.
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Recent studies have also shown important non-hematopoietic effects of Epo.
The present invention covers compositions and formulations comprising agents, compounds and drugs of the present invention, their derivatives, analogs, and isomers.
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PRCA and the less severe form of antibody reaction.
Except for a small difference in the sex ratio, the baseline characteristics of the patients were similar in the two groups ( Table 1 Demographic and Baseline Characteristics.
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