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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.

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Other means for measuring stability can be used and are well known to persons of skill in the art.

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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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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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ESA-treated patients) reported that mortality was similar between the 2 groups (10% vs 11%, respectively).

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Verification of the similarity of biosimilars to innovator biopharmaceuticals remains a key challenge.

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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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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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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.

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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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