2012
DOI: 10.1016/j.biologicals.2012.02.003
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Immunogenicity of recombinant human erythropoietin in Korea: A two-year cross-sectional study

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Cited by 14 publications
(8 citation statements)
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“… 86–88 Recent studies have shown that anti-EPO antibody-mediated PRCA is a rare but important adverse effect in patients with CKD who take rHuEPO. 89–91 …”
Section: Causes Of Resistance To Treatment With Recombinant Human Erymentioning
confidence: 99%
See 1 more Smart Citation
“… 86–88 Recent studies have shown that anti-EPO antibody-mediated PRCA is a rare but important adverse effect in patients with CKD who take rHuEPO. 89–91 …”
Section: Causes Of Resistance To Treatment With Recombinant Human Erymentioning
confidence: 99%
“… 87 Moreover, no commercial laboratory kit is available for the detection of anti-EPO antibodies in the clinical practice. 89 …”
Section: Causes Of Resistance To Treatment With Recombinant Human Erymentioning
confidence: 99%
“…The letter describes the process for marketing authorization approval used in lowand middle-income countries as relying on 'a loosely designed and practised clinical study'. It is acknowledged that it is now well established that ignoring the need for appropriate assessment of quality, preclinical and clinical performance of biotherapeutics (including biosimilars) can lead to serious clinical problems: a good example of this is the high incidence of PRCA (pure red cell aplasia) development following treatment with the many EPO (erythropoietin) products which are approved in Thailand [7,8]. In any case, quality assessment, which is the foundation of the biosimilarity exercise, is normally cheaper than conducting clinical trials and so the reason for relying solely on clinical assessment seems illogical.…”
Section: Access To Safe and Eff Ective Biopharmaceuticalsmentioning
confidence: 99%
“…We and other researchers have used the UT-7/EPO cell line for the EPO bioassay, EPO signaling study, and EPO-mimetic drug test (Fan et al, 2006;Liu et al, 2007;Shin et al, 2010Shin et al, , 2012Kessler et al, 2012). Little information is available regarding nonpeptide small molecules with UT-7/EPO proliferative activities.…”
Section: Introductionmentioning
confidence: 99%