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Use of ESAs in other tumors was left to contractor discretion.

Immunogenicity of granulocyte-macrophage colony-stimulating factor (GM-CSF) products in patients undergoing combination therapy with GM-CSF.

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Phase III, randomized, double-blind study of epoetin alfa compared with placebo in anemic patients receiving chemotherapy.

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Red cell distribution width is associated with long-term prognosis in patients with stable coronary artery disease.

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Following FDA inspections in 2015, McNEIL-PPC received notifications from the FDA that all three manufacturing facilities are in conformity with applicable laws and regulations.

Our review of other literature was to shed light on the possible underlying biological processes that may account for the trial findings.

Although LMWHs as a class have similar antithrombotic effects, they comprise a diverse group of agents with distinct biochemical and pharmacological profiles.

Since 2007, fewer chemotherapy-associated anemia patients in the United States and Europe receive ESAs.

You should not use the information contained here for diagnosing or treating a health problem or disease.

Further differences were identified in the general regulatory requirements including the reference product, definitions of biological drugs and historic regulatory conditions for distinct product classes.

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Anemia of Chronic Disease and Renal Disease.

Sequential evaluation of serum hepcidin in anemic myeloma patients: Study of correlations with myeloma treatment, disease variables, and anemia response.

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It was the beginning of a new era, as it paved the way for more centres to be built within other housing estates, bringing affordable dialysis to the doorsteps of kidney patients in Singapore.

The low refractive index of protein particles combined with an increased refractive index of the background due to the high protein concentration resulted in a significant underestimation of the particle numbers.

In addition, in patients with end-stage renal disease, chronic immune activation can arise from contact activation of immune cells by dialysis membranes, from frequent episodes of infection, or from both factors, and such patients present with changes in the homeostasis of body iron that is typical of anemia of chronic disease.

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The primary endpoint was reached by 98% of the subjects in the Mircera arm and 96% of the subjects in the Darbepoetin alfa arm.

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Ensuring native-like higher order structure (secondary, tertiary and quaternary structures) in a protein produced from both pre- and post-change manufacturing processes is essential since the overall three dimensional configuration not only defines a protein's stability and functionality, but also its efficacy and safety when being used as a therapeutic.

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In this article, we summarize and put into context the arsenal of analytical methods available and the regulatory implications of comparability assessment for several classes of biologics reviewed by the FDA.

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Examples of ESAs include epoetin alfa (Eprex, Procrit or Epogen) or the longer acting darbepoetin alfa (Aranesp).

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