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Therefore, it is medically desirable to provide monotherapies comprising single agents, compounds or drugs capable of preventing or treating multiple conditions or diseases.
Although some biologics are regulated under the Federal Food, Drug, and Cosmetic Act (FDCA) for historical reasons, and are, therefore, candidates for generic production through section 505(j), an Abbreviated New Drug Application (ANDA), or through 505(b)(2), using data from previously approved innovator biologics to make claims of safety and effectiveness, there is no abbreviated path for replica or closely similar follow-on products for biologics under the PHS Act.
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In a non-randomised study of 191 patients undergoing neoadjuvant chemoradiotherapy and resection for squamous cell carcinoma of the oral cavity or oropharynx, treatment with epoetin was associated with significantly better local control and survival compared with an untreated historical control group ().
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HX575, recombinant human epoetin alfa, for the treatment of chemotherapy-associated symptomatic anaemia in patients with solid tumours.
The three antibody tests that have been developed for testing sera for the presence of anti-erythropoietin (anti-EPO) antibodies.
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ESA treatment is not recommended when patients are treated with myelosuppressive chemotherapy with curative intent.
Tres de los cinco sujetos con dosis bajas de los mismos medicamentos cumplan los criterios de resistencia a la insulina.
The haematopoietic effect of recombinant human erythropoietin in haemodialysis is independent of the mode of administration (i.
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Liberal R, Grant CR, MieliVergani G, Diego Vergani D. Autoimmune hepatitis: a comprehensive review.
Erythropoiesis-stimulating agents in the treatment of anaemia in cancer patients: ESMO Clinical Practice Guidelines for use.
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Pharmacodynamics Epoetin beta is a glycoprotein that stimulates the proliferation and differentiation processes of the erythroid stem cell compartment and also has a stimulatory effect on the proliferation and maturation compartment of the erythron.
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Three forms of recombinant erythropoietin are available: epoetin alfa (human recombinant erythropoietin), epoetin beta (NeoRecormon, which differs from epoetin alfa in terms of glycosylation and sialic acid content), and a longer-acting derivative of epoetin alfa (darbepoetin).
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MAbs were not reviewed, given that they did not rank in the top 20 biologics according to 2006 annual sales.
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CERA (Continuous Erythropoietin Receptor Activator): a new erythropoiesis-stimulating agent for the treatment of anemia.
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