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It is important to note that anemia of chronic disease, if marked, can be a reflection of a more progressive underlying disease.
Investigator-Initiated Clinical Trials In Malaysia And The Role Of The Clinical Research Centre Of The Ministry Of Health.
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Studies of cognitive function that include people receiving non-CNS-localized radiation treatment are confounded with chemotherapy or hormone manipulation and are included in those sections of this review.
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Even though their antithrombotic effects are similar, the LMWHs are heterogeneous compounds; they are produced by different processes and have distinct biochemical and pharmacological properties ().
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Regulatory guidelines for stability studies that may be applied to comparability assessments can be found in ICH Q3C (), ICH Q5C (ICH Q3C, ) and ICH Q5E ().
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About 80% of absorbed iron is delivered to the bone marrow.
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EPREX Injection (Ee-prex) is a medicine which is used in treating anaemia in people with cancer, treating anaemia in people with kidney problems, reducing the risk of needing a blood transfusion in people who are having surgery, treating anaemia in people who are having dialysis and increasing blood production for self-donation before surgery.
The numbers of case reports and estimates of exposure-adjusted incidence were analyzed according to the product, the cause of anemia, the route of administration, the country in which pure red-cell aplasia was identified, and the date on which pure red-cell aplasia was reported.
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Healthy kidneys produce a hormone called erythropoietin (EPO).
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Darbepoetin alfa administered at varying intervals compared with weekly epoetin alfa for treating chemotherapy-induced anemia: a pooled analysis of 20 clinical trials.
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The demand to improve the safety and efficacy profile of new drugs has led to a heightened consideration of applying emerging technologies, based mainly on in silico and in vitro methods, to attempt to predict immunogenicity.
How should biosimilars be named and labeled?
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In Südafrika wird seit 1997 durch die Firma Bioclones aus Johannesburg ein EPO-Präparat unter dem Handelsnamen Repotin (EPO α) hergestellt.
Erythropoietin (often shortened to EPO) is a naturally occurring hormone, secreted by the kidneys, whose function is to regulate red blood cell production.
This section outlines treatments that are the standard of care (the best known treatments available) for this specific disease.
To reduce cardiovascular risks, the lowest dose of darbepoetin alpha should be used.
The extent to which people recover function that declines during treatment is not known.
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The properties of a potential biopharmaceutical that will elicit an immunological response in a patient are poorly understood and at present cannot be adequately predicted from in vitro or in vivo (animal) testing, structural knowledge or analytical measurements of the biopharmaceutical.
In all, a conductive working environment for staff is necessary to instill a professional yet caring attitude whilst discharging their duties towards improving the health of the Malaysian population.
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The risk evaluation and mitigation strategy established for reference products should be undertaken for related biosimilars.
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The greatest structural difference between the innovative epoetin alpha and the biosimilar is its high level of mannose.
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Many people with kidney disease need iron supplements and EPO to raise their red blood cell count to a level that will reduce the need for red blood cell transfusions.
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