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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
DC Field | Value | Language |
---|---|---|
dc.contributor.advisor | 장인진 | - |
dc.contributor.author | 안리영 | - |
dc.date.accessioned | 2017-07-19T10:23:42Z | - |
dc.date.available | 2017-07-19T10:23:42Z | - |
dc.date.issued | 2014-02 | - |
dc.identifier.other | 000000017242 | - |
dc.identifier.uri | https://hdl.handle.net/10371/132652 | - |
dc.description | 학위논문 (석사)-- 서울대학교 대학원 : 의학과, 2014. 2. 장인진. | - |
dc.description.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. | - |
dc.description.tableofcontents | CONTENTS
ABSTRACT I CONTENTS III LIST OF TABLES IV LIST OF FIGURES V INTRODUCTION 1 MATERIALS AND METHODS 5 SOURCE OF PHARMACOKINETIC DATA 5 SUBJECTS 6 NONCOMPARTMENT PHARMACOKINETIC ASSESSMENT 6 POPULATION PHARMACOKINETIC MODEL DEVELOPMENT 7 MODEL EVALUATION 9 STATISTICAL ANALYSIS 9 RESULTS 11 SUBJECTS 11 PHARMACOKINETICS OF ETANERCEPT 13 THE FINAL PHARMACOKINETIC MODEL 20 MODEL EVALUATION 21 DISCUSSION 31 RERERENCE 36 국문 초록 41 | - |
dc.format | application/pdf | - |
dc.format.extent | 1158391 bytes | - |
dc.format.medium | application/pdf | - |
dc.language.iso | en | - |
dc.publisher | 서울대학교 대학원 | - |
dc.subject | etanercept | - |
dc.subject | biologics | - |
dc.subject | pharmacokinetics | - |
dc.subject | TNF inhibitor | - |
dc.subject.ddc | 610 | - |
dc.title | Pharmacokinetic Analysis of Etanercept Following a Single Subcutaneous Dose in Healthy Volunteers: a Combined Analysis of Five Clinical Trials | - |
dc.title.alternative | 건강한 한국인 자원자에서 Etanercept 단회 피하투여에 의한 약동학적 특성에 관한 연구 | - |
dc.type | Thesis | - |
dc.description.degree | Master | - |
dc.citation.pages | v, 42 | - |
dc.contributor.affiliation | 의과대학 의학과 | - |
dc.date.awarded | 2014-02 | - |
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