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권준철,권오환,정래웅,김나윤,송선아,최일섭,이준옥,Takahiko Horiuchi 한국통합생물학회 2021 Animal cells and systems Vol.25 No.3
LBAL was developed as an adalimumab (Humira®) biosimilar using Chinese hamster ovary cell lines. Comparable quality, safety, and efficacy between a biosimilar and its reference product should be ensured for regulatory approval. Here, we present the results of a comprehensive physicochemical and biological characterization between LBAL and Humira®. As physicochemical attributes, primary and higher-order structure, N-glycan profile, and disulfide linkage were investigated. Biological attributes were evaluated by target/receptor binding analysis and in vitro/ex vivo cell-based assays, which are linked to mechanisms of action. As a result, LBAL had the identical amino acid sequence, similar post-translational modifications and N-/C-terminal variants, and comparable primary, secondary, and tertiary structures and disulfide linkage profile. However, some differences in N-glycan profiles were observed. Biological activities, including tumor necrosis factor (TNF) binding, TNF-neutralization, apoptosis, Fc receptor binding, and complementdependent cytotoxicity, were largely consistent. Despite a slightly lower antibody-dependent cellular cytotoxicity activity in LBAL, this difference was not significant under physiological conditions. As indicated, this extensive analytical characterization and functional comparison assessment showed that LBAL was similar to Humira®, with minor differences of no clinical relevance. Taken together, our comparative assessment of physicochemical and biological attributes demonstrated that LBAL is structurally and functionally very similar to Humira®, supporting the biosimilarity of clinical efficacy and safety.
권준철,최용전,정용규,Kwon, Jun Cheol,Choi, Yong Jeon,Jung, Yong Gyu 서비스사이언스학회 2014 서비스연구 Vol.4 No.1
Telemedicine is performed at a place far away from medical practice with physicians and patients by the means of communication appropriately. It will be identified in general the remote medical service to deliver the medical information and also defined as any action by interactive information communication technology. Medical services can be said to be fused as television, communication, computer, engineering of various technologies of information and communication applications. If doctors can not be reached due to distances away from the patient, Information technologies could be used to get medical information and to give expert advice provided by the system remotely. And it could be used patient care as well as medical administration, medical education, professional advice and consulting. In this paper, we take a look at the legal requirements of telemedicine for improving regulatory in the current law to investigate the matter. 원격의료란 의사와 환자가 멀리 떨어져 있는 장소에서 행하는 의료행위로, 통신 수단에 의해 환자의 상태를 파악하여 적절한 진료를 하는 것이다. 일반적으로 상호작용하는 정보통신 기술을 이용하여 원거리에 의료정보와 의료서비스를 전달하는 모든 활동으로 정의된다. 즉 텔레비전, 통신, 컴퓨터, 공학들의 정보통신의 다양한 기술과 의료서비스가 융합된 응용 분야라고 할 수 있다. 환자 및 정보가 먼 거리로 떨어져 있거나 시간적으로 많은 차이가 발생하는 등 여러 가지 문제로 인해 도달할 수 없는 경우 의료정보 및 전문적 조언을 원격으로 제공하는 시스템으로, 환자 진료뿐만 아니라 의료행정, 의학교육, 자문과 의뢰 등을 포함하는 포괄적인 개념으로 쓰인다. 이에 본 논문에서는 원격의료의 법적인 규제를 살펴보고, 현행법에서 규제개선의 쟁점사항을 분석한다.
기계적 합금화에 의한 Skutterudite계 Fe<sub>x</sub>Co<sub>4-x</sub>Sb<sub>12</sub>의 합성 및 열전특성
권준철,김일호,어순철,Kwon, Joon-Chul,Kim, Il-Ho,Ur, Soon-Chul 한국분말야금학회 2005 한국분말재료학회지 (KPMI) Vol.12 No.5
Fe-doped skutterudite $CoSb_3$ with a nominal composition of $Fe_{x}Co_{4-x}Sb_{12}(0\;{\le}\;x\;{\le}\;2.5)$ has been synthesized by mechanical alloying (MA) of elemental powders, followed by hot pressing. Phase transformations during mechanical alloying and hot pressing were systematically investigated using XRD. Single phase skutterudite was successfully produced by vacuum hot pressing using as-milled powders without subsequent annealing. However, second phase in the form of marcasite structure $FeSb_2$ was found to exist in case of $x\;{\ge}\;2$, suggesting the solubility limit of Fe with Co in this system. Thermoelectric properties as functions of temperature and Fe contents were evaluated for the hot pressed specimens. Fe substitution up to x=1.5 with Co in $Fe_{x}Co_{4-x}Sb_{12}$ appeared to increase thermoelectric figure of merit (ZT) and the maximum ZT was found to be 0.78 at 525K in this study.