Cited 2 times in
Comparison of biosimilar filgrastim with a reference product: pharmacokinetics, pharmacodynamics, and safety profiles in healthy volunteers
DC Field | Value | Language |
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dc.contributor.author | 김춘옥 | - |
dc.contributor.author | 류병원 | - |
dc.contributor.author | 박민수 | - |
dc.contributor.author | 홍태곤 | - |
dc.date.accessioned | 2019-07-11T02:58:28Z | - |
dc.date.available | 2019-07-11T02:58:28Z | - |
dc.date.issued | 2018 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/169795 | - |
dc.description.abstract | Purpose: Filgrastim, a granulocyte-colony stimulating factor, is used to treat patients with neutropenia, including neutropenic fever. Leucostim® is a recombinant filgrastim product tested for biosimilarity with its reference product, Neupogen®. We conducted a comparative clinical trial of the 2 products. Patients and methods: A randomized, open-label, 2-way crossover, single-dose Phase I study was conducted for 56 healthy subjects. After a 5 and 10 μg/kg single subcutaneous administration of test and reference product, pharmacokinetic and pharmacodynamic parameters (absolute neutrophil count and CD34+ cell count) were compared. During the study, safety tests and adverse event monitoring were performed. Results: The test and the reference products had a comparable pharmacokinetic, pharmacodynamic, and safety profile. In both 5 and 10 μg/kg dosing, the 90% CIs of the test to reference ratio for primary parameters (peak plasma concentration and area under the plasma concentration vs time curve from time 0 extrapolated to the infinite time for plasma filgrastim concentration; maximal effect and area under the time-effect curve from time 0 to time of the last quantifiable effect for absolute neutrophil count) were within the 0.8-1.25 range. In addition, safety profiles between the 2 products were similar without any serious adverse events. Conclusion: This study has provided firm clinical evidence that the test filgrastim product is similar to its reference filgrastim product. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Dove Press Limited | - |
dc.relation.isPartOf | DRUG DESIGN DEVELOPMENT AND THERAPY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Biosimilar Pharmaceuticals/pharmacokinetics* | - |
dc.subject.MESH | Cross-Over Studies | - |
dc.subject.MESH | Filgrastim/adverse effects | - |
dc.subject.MESH | Filgrastim/pharmacokinetics* | - |
dc.subject.MESH | Filgrastim/pharmacology | - |
dc.subject.MESH | Healthy Volunteers | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.title | Comparison of biosimilar filgrastim with a reference product: pharmacokinetics, pharmacodynamics, and safety profiles in healthy volunteers | - |
dc.type | Article | - |
dc.contributor.college | Others | - |
dc.contributor.department | Severance Hospital (세브란스병원)/임상시험센터 | - |
dc.contributor.googleauthor | Chungam Choi | - |
dc.contributor.googleauthor | Byung Won Yoo | - |
dc.contributor.googleauthor | Choon ok Kim | - |
dc.contributor.googleauthor | Taegon Hong | - |
dc.contributor.googleauthor | Byung Hak Jin | - |
dc.contributor.googleauthor | Kwang-Seok Seo | - |
dc.contributor.googleauthor | Ja Yun Jang | - |
dc.contributor.googleauthor | Min Soo park | - |
dc.identifier.doi | 10.2147/DDDT.S158277 | - |
dc.contributor.localId | A04735 | - |
dc.contributor.localId | A02468 | - |
dc.contributor.localId | A01468 | - |
dc.contributor.localId | A05194 | - |
dc.relation.journalcode | J02859 | - |
dc.identifier.eissn | 1177-8881 | - |
dc.identifier.pmid | 30122896 | - |
dc.subject.keyword | G-CSF | - |
dc.subject.keyword | bioequivalence | - |
dc.subject.keyword | biologics | - |
dc.subject.keyword | biosimilar | - |
dc.contributor.alternativeName | Kim, Choon Ok | - |
dc.contributor.affiliatedAuthor | 김춘옥 | - |
dc.contributor.affiliatedAuthor | 류병원 | - |
dc.contributor.affiliatedAuthor | 박민수 | - |
dc.contributor.affiliatedAuthor | 홍태곤 | - |
dc.citation.volume | 12 | - |
dc.citation.startPage | 2381 | - |
dc.citation.endPage | 2387 | - |
dc.identifier.bibliographicCitation | DRUG DESIGN DEVELOPMENT AND THERAPY, Vol.12 : 2381-2387, 2018 | - |
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