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Hemodialysis patients should receive this medication by injection into a vein.
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Under the Consent Decree, after receiving notice from the FDA of being in compliance with applicable laws and regulations, each of the three facilities is subject to a five-year audit period by a third-party cGMP expert.
At some point in the process, it will also be important for both the innovators and the developers of biosimilars to determine which analytical methods are appropriate for inclusion with regulatory filings, and to what degree these analytical measurements contribute to assessing physicochemical stability and clinical relevance, especially given the concerns stemming from adverse clinical events involving biopharmaceuticals (see the 27 October 2010 press release on the FDA website) and the vexing problem of assessing comparability in relation to immunogenicity.
Iron chelation therapy is used to remove the excess iron caused by blood transfusions.
Prevalence of anemia in cancer patients undergoing radiation therapy.
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During the manufacture of biopharmaceutical proteins (which includes steps such as cell culture overexpression, purification, transportation, storage and handling), factors can be encountered that can perturb some of these weak forces in proteins, causing alterations to the three-dimensional structure without changing the primary structure of the protein.
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Patients with CRS and anaemia and healthy controls were included.
This equity account includes the results of translating certain balance sheet assets and liabilities at current exchange rates and some accounts at historical rates, except for those located in highly inflationary economies.
In the opinion of the Work Group, the frequency of Hb monitoring in patients treated with ESAs should be at least monthly.
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Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products.
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