Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 유대현 | - |
dc.date.accessioned | 2017-08-08T04:39:24Z | - |
dc.date.available | 2017-08-08T04:39:24Z | - |
dc.date.issued | 2015-10 | - |
dc.identifier.citation | EXPERT REVIEW OF CLINICAL IMMUNOLOGY, v. 11, NO Special SI, Page. 25-31 | en_US |
dc.identifier.issn | 1744-666X | - |
dc.identifier.issn | 1744-8409 | - |
dc.identifier.uri | http://www.tandfonline.com/doi/full/10.1586/1744666X.2015.1090311 | - |
dc.identifier.uri | http://hdl.handle.net/20.500.11754/28356 | - |
dc.description.abstract | Objective: To compare the pharmacokinetics (PK), safety and tolerability of biosimilar infliximab (CT-P13 [Remsima (R), Inflectra (R)]) with two formulations of the reference medicinal product (RMP) (Remicade (R)) from either Europe (EU-RMP) or the USA (US-RMP). Methods: This was a double-blind, three-arm, parallel-group study (EudraCT number: 2013-003173-10). Healthy subjects received single doses (5 mg/kg) of CT-P13 (n = 71), EU-RMP (n = 71) or US-RMP (n = 71). The primary objective was to compare the PK profiles for the three formulations. Assessments of comparative safety and tolerability were secondary objectives. Results: Baseline demographics were well balanced across the three groups. Primary end points (C-max, AUC(last) and AUC(inf)) were equivalent between all formulations (CT-P13 vs EU-RMP; CT-P13 vs US-RMP; EU-RMP vs US-RMP). All other PK end points supported the high similarity of the three treatments. Tolerability profiles of the formulations were similar. Conclusion: The PK profile of CT-P13 is highly similar to EU-RMP and US-RMP. All three formulations were equally well tolerated. | en_US |
dc.description.sponsorship | This study was conducted by Celltrion. DH Yoo is a Scientific Consultant, and has received a research grant, which was not related to biosimilars from Celltrion. W Park has received research grants and consultancy fees from Celltrion. SJ Lee and J Yun are full-time employees of Celltrion. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. | en_US |
dc.language.iso | en | en_US |
dc.publisher | EXPERT REVIEWS | en_US |
dc.subject | biosimilar | en_US |
dc.subject | CT-P13 | en_US |
dc.subject | European Union | en_US |
dc.subject | healthy subjects | en_US |
dc.subject | infliximab | en_US |
dc.subject | pharmacokinetics | en_US |
dc.subject | safety | en_US |
dc.subject | USA | en_US |
dc.title | Comparison of the pharmacokinetics and safety of three formulations of infliximab (CT-P13, EU-approved reference infliximab and the US-licensed reference infliximab) in healthy subjects: a randomized, double-blind, three-arm, parallel-group, single-dose, Phase I study | en_US |
dc.type | Article | en_US |
dc.relation.no | Special SI | - |
dc.relation.volume | 11 | - |
dc.identifier.doi | 10.1586/1744666X.2015.1090311 | - |
dc.relation.page | 25-31 | - |
dc.relation.journal | EXPERT REVIEW OF CLINICAL IMMUNOLOGY | - |
dc.contributor.googleauthor | Park, Won | - |
dc.contributor.googleauthor | Lee, Sang Joon | - |
dc.contributor.googleauthor | Yun, Jihye | - |
dc.contributor.googleauthor | Yoo, Dae Hyun | - |
dc.relation.code | 2015011356 | - |
dc.sector.campus | S | - |
dc.sector.daehak | COLLEGE OF MEDICINE[S] | - |
dc.sector.department | DEPARTMENT OF MEDICINE | - |
dc.identifier.pid | dhyoo | - |
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