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Pharmacokinetic Analysis of Etanercept Following a Single Subcutaneous Dose in Healthy Volunteers: a Combined Analysis of Five Clinical Trials : 건강한 한국인 자원자에서 Etanercept 단회 피하투여에 의한 약동학적 특성에 관한 연구

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Authors

안리영

Advisor
장인진
Major
의과대학 의학과
Issue Date
2014-02
Publisher
서울대학교 대학원
Keywords
etanerceptbiologicspharmacokineticsTNF inhibitor
Description
학위논문 (석사)-- 서울대학교 대학원 : 의학과, 2014. 2. 장인진.
Abstract
Introduction: Etanercept is a soluble recombinant human tumor necrosis factor receptor fusion protein which is used for the treatment of rheumatoid arthritis and other inflammatory diseases. The aim of this study was to identify the factors that affect the pharmacokinetics (PK) of etanercept by comparing the results of PK analysis from five clinical trials.
Methods: The serum etanercept concentration data of 169 healthy subjects from five clinical trials were pooled for both noncompartmental and compartmental analyses. Serial blood samples were collected up to 3 or 4 weeks after a single subcutaneous administration of etanercept 25 mg. Enzyme-linked immunosorbent assay (ELISA) was used to determine the serum concentrations of etanercept.
Results: Noncompartmental analysis showed significant differences in PK parameters such as the maximum concentration, area under the time-concentration curve, and half-life, among the five trials. Population PK analysis demonstrated that PK parameters were influenced by formulation, body weight and the study effect. Differences in the distribution of PK parameters among the five clinical studies were attributed to differences in bioanalytic methods, manufacturing batch variability of etanercept, and changes in the manufacturing process.
Conclusion: Considering the complexity of protein products, identifying variations is important and these results may contribute to deepening our understanding of such variability.
Language
English
URI
https://hdl.handle.net/10371/132652
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