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Even minor changes to the original manufacturing process may result in alterations to the secondary, tertiary, and quaternary structure of the molecule, which may have an impact on the efficacy and safety of the drug.
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However, due to space limitations, this review is not meant to be comprehensive of all drug-induced hematological dyscrasias.
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The Minimum Anticipated Biological Effect Level (MABEL) for selection of first human dose in clinical trials with monoclonal antibodies.
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Darbepoetin (Aranesp): 2002 FDA statistical review (redacted).
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Conconi had worked on the idea of giving athletes of their own blood in the 1980s.
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ASH suggested that instead of identifying a hemoglobin level when ESA therapy is covered by Medicare, CMS should identify a level when the physician should evaluate the possible need for ESA therapy.
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In responding to hypoxia, erythropoietin interacts with progenitor stem cells to increase red cell production.
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