가바펜틴 400밀리그람 캡슐의 생물학적동등성시험

김세미,강현아,조혜영,신새벽,류희두,윤화,이용복,Kim, Se-Mi,Kang, Hyun-Ah,Cho, Hea-Young,Shin, Sae-Byeok,Yoo, Hee-Doo,Yoon, Hwa,Lee, Yong-Bok 대한약학회 2008 약학회지 Vol.52 No.3

Gabapentin, [1-(aminomethyl) cyclohexaneacetic acid], a structural analog of $\gamma$-aminobutyric acid (GABA), is being developed for the treatment of epilepsy. Unlike GABA, gabapentin crosses the blood-brain barrier after systemic administration. Gabapentin is an effective antiepileptic drug in patients with partial and secondarily generalized seizures who are uncontrolled with use of existing anticonvulsant drug therapy. The purpose of the present study was to evaluate the bioequivalence of two gabapentin 400 mg capsules, $Neurontin^{(R)}$ capsule 400 mg (Pfizer Inc.) and Gabatin capsule 400 mg (Korean Drug Co. Ltd), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of gabapentin from the two gabapentin formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty six healthy male subjects, 23.58$\pm$1.50 years in age and 66.74$\pm$8.31 kg in body weight, were divided into two groups and a randomized 2$\times$2 cross-over study was employed. After one capsule containing 400 mg as gabapentin were orally administered, blood was taken at predetermined time intervals and the concentrations of gabapentin in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar at all dissolution media. In addition, the pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Neurontin^{(R)}$ capsule 400 mg, were 2.04, -3.68 and 16.79% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log 0.91$\sim$log 1.16 and log 0.87$\sim$log 1.11 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Gabatin capsule 400 mg was bioequivalent to $Neurontin^{(R)}$ capsule 400 mg.

한국인에 있어서 MDRI 유전자(exon 12, 21 및 26)의 일배체형 분석

김세미,박선애,조혜영,이용복,Kim, Se-Mi,Park, Sun-Ae,Cho, Hea-Young,Lee, Yong-Bok 한국약제학회 2008 Journal of Pharmaceutical Investigation Vol.38 No.6

The aim of this study was to investigate the frequency of the SNPs on MDR1 exon 12, 21 and 26 in Korean population and to analyze haplotype frequency on MDR1 exon 12, 21 and 26 in Korean population. A total of 426 healthy subjects was genotyped for MDR1, using polymerase chain reaction-based diagnostic tests. Haplotype was statistically inferred using an algorithm based on the expectation-maximization (EM). MDR1 C1236T genotyping revealed that the frequency for homozygous wild-type (C/C), heterozygous (C/T) and for homozygous mutant-type (T/T) was 20.19%, 46.48% and 33.33%, respectively. MDR1 G2677T/A genotyping revealed that the frequency for homozygous G/G, heterozygous G/T, homozygous T/T, heterozygous G/A, heterozygous T/A and for homozygous A/A type was 30.75%, 42.26%, 9.86%, 7.51 %, 7.04% and 2.58%, respectively. MDR1 C3435T genotyping revealed that the frequency for homozygous wild-type (C/C), heterozygous (C/T) and for homozygous mutant-type (T/T) was 38.73%, 50.24% and 11.03%, respectively. Twelve haplotypes were observed. Of the three major haplotypes identified (CGC, TTT and TGC), the CGC haplotype were mainly predominant in the Korean populations and accounted for 29.96% of total haplotype in Korean.

세프질$^{(R)}$ 정 250밀리그람 (세프프로질 250밀리그람)에 대한 프로세질 정 250밀리그람의 생물학적동등성

김세미,강민선,조혜영,이용복,Kim, Se-Mi,Kang, Min-Sun,Cho, Hea-Young,Lee, Yong-Bok 한국임상약학회 2010 한국임상약학회지 Vol.20 No.3

Cefprozil is a broad-spectrum oral beta-lactam cephalosporin consisting of cis- and trans-isomeric mixture whose ratio is approximately 90:10. Cefprozil is used to treat certain infections caused by bacteria such as bronchitis and ear, skin, and throat infections. The purpose of the present study was to evaluate the bioequivalence of two cefprozil tablets, $Cefzil^{(R)}$ tablet 250 mg (BMS Pharmaceutical Korea., Ltd.) and Procezil tablet 250 mg (Hanmi Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of cefprozil from the two cefprozil formulations were tested using KP VIII Apparatus I method with water dissolution media. Thirty five healthy male subjects, $24.00{\pm}1.53$ years in age and $69.77{\pm}9.99$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After four tablets containing 1000 mg as cefprozil were orally administered, blood samples were taken at predetermined time intervals and the concentrations of cefprozil in serum were determined using HPLC/UV detector. The dissolution profiles of two formulations were similar in water tested dissolution media. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ on the basis of total-cefprozil were calculated, and computer program (K-BE Test 2002) was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Cefzil^{(R)}$ tablets, were -0.81%, -3.00% and -6.83% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log 0.9515~log 1.0454 and log 0.9613~log 1.0465 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Procezil tablet was bioequivalent to $Cefzil^{(R)}$ tablet.

가바펜틴 800밀리그람 정제의 생물학적동등성시험

김세미,신새벽,강현아,조혜영,이용복,Kim, Se-Mi,Shin, Sae-Byeok,Kang, Hyun-Ah,Cho, Hea-Young,Lee, Yong-Bok 대한약학회 2008 약학회지 Vol.52 No.4

Gabapentin, 1-(aminomethyl) cyclohexaneacetic acid, is a amino acid derivative, and is clinically effective in the treatment of neuropathic pain and partial seizures of epilepsy as a complementary therapy. The purpose of the present study was to evaluate the bioequivalence of two gabapentin tablets, $Neurontin^{R}$ tablet 800 mg (Pfizer Pharmaceuticals Co., Ltd.) and Gabapenin tablet 800 mg (Hanmi Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of gabapentin from the two gabapentin formulations in vitro was tested using KP VIII Apparatus II method with 0.06 M HCI dissolution media. Twenty six healthy male subjects, $23.85{\pm}2.24$ years in age and $69.40{\pm}11.11$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After a single tablet containing 800 mg as gabapentin was orally administered, blood samples were taken at predetermined time intervals and the concentrations of gabapentin in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar in the tested dissolution media. The pharmacokinetic parameters such as $AUC_{t}$, $C_{max}$ and $T_{max}$ were calculated, and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_{t}$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Neurontin^{R}$, were 1.28%, 0.63% and 0.62% for $AUC_{t}$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., $log0.9097{\sim}log1.1598$ and $log0.8919{\sim}log1.1262$ for $AUC_{t}$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Gabapenin tablet 800 mg was bioequivalent to $Neurontin^{R}$ tablet 800 mg.

BX 디자인 경험이 브랜드의 가치지각, 신뢰도, 충성도에 미치는 영향에 관한 연구 - 경험제공수단을 통한 브랜드경험을 중심으로 -

김세미 ( Kim Se-mi ) 커뮤니케이션디자인학회(구 시각디자인학회) 2017 커뮤니케이션 디자인학연구 Vol.61 No.-

현재 마케팅 패러다임의 변화에서 뿐만 아니라 각 학문적인 영역에서 경험의 중요성이 부각되어지고 있다. 따라서 브랜드 경영의 차원에서 BX디자인의 영역을 세분화하여 다룰 수 있는 연구가 필요한 실정이다. 본 연구에서는 디자인 경영 측면에서 BX디자인의 영향력을 조사하고자 하였으며, 이에 BX디자인의 경험제공수단 (ExPros)을 7가지 영역으로 선정하고 BX디자인이 브랜드 가치지각, 브랜드 신뢰도, 브랜드 충성도에 어떠한 영향을 미치는지를 알아보고자 하였다. 연구목적을 바탕으로 연구문제들을 설정한 후, 이를 실증연구를 통해 밝혔으며, 연구결과 경험제공수단을 통한 BX디자인 경험은 브랜드 가치지각, 브랜드 충성도, 브랜드 신뢰도 순으로 긍정적인 영향을 미친다는 것이 확인되었다. 연구의 고찰에서 브랜드 경험에 있어서 각 종속변수들의 마케팅적 부분의 역할을 살펴보았다. 본 연구 결과를 통해 기업의 마케팅뿐만 아니라 경영차원에서 BX디자인의 긍정적인 효과 및 앞으로의 가능성을 제안할 수 있었다. On top of changes in the current marketing paradigm, the importance of experience is highlighted in each academic area. Thus, it would be necessary to have researches that subdivide the BX design area in the aspect of brand management. Therefore, this study aimed to research the influence of BX design in the aspect of design management. Selecting seven areas of experience providers(ExPros) of BX design, it aimed to understand the effects of BX design on the brand value perception, brand reliability, and brand loyalty. After setting up research questions based on the objective of this study, they were revealed through empirical research. In the results, the BX design experience through experience providers had positive effects on the brand value perception, brand loyalty, and brand reliability in order. In the consideration of study results, the marketing roles of each dependent valuable were examined regarding brand experience. Based on the results of this study, the positive effects & possibilities of BX design could be suggested in the aspect of corporate marketing and management.

802.11 WLAN 방송 패킷을 이용한 신뢰성 있는 실시간 멀티미디어 데이터 전송 방법

김세미 ( Se-mi Kim ),김동현 ( Dong-hyun Kim ),김종덕 ( Jong-deok Kim ) 한국정보처리학회 2011 한국정보처리학회 학술대회논문집 Vol.18 No.1

최근 IEEE 802.11 WLAN(Wireless Local Area Network)에서 실시간 멀티미디어 서비스가 증가하고 있다. WLAN 의 패킷 전송방식은 Unicast 또는 Broadcast 방식이 있다. Unicast 방식은 재전송을 포함하여 유실율이 적으나 사용자가 증가할수록 AP 에서 필요한 무선 자원의 크기가 증가한다. 무선 자원의 크기가 증가하면 AP 부하가 증가하여 서비스 수용에 한계가 있다. Broadcast 방식은 사용자 수에 상관 없이 무선 자원의 크기가 일정하나, 패킷 유실율이 높다. 본 논문에서는 이러한 문제점을 해결하기 위해 Broadcast 와 FEC(Forward Error Correction) Erasure Code 기반 기술을 적용하는 것을 제안한다. 방송 패킷을 이용 AP 의 부하를 줄이고, Reed Solomon Erasure Code 를 적용하여 패킷 유실 복구율을 높인다. 이러한 방법을 통하여 다수의 사용자에게 안정적인 실시간 멀티미디어 방송 서비스를 제공 할 수 있다. 제안한 방법을 검증하기 위해 Android Platform 에서 FEC 적용 유무에 따른 수신율을 측정하였다. 그 결과 유실율 30%미만인 Broadcast 환경에서 96.4% 이상의 수신율을 보였다.

‘把’자문의 정보구조 연구

金世美(Kim Se-mi) 중국어문학연구회 2009 중국어문학논집 Vol.0 No.56

유아교육현장에서 유아 교사의 사회적 소수자에 대한 인식 연구

김세미(Kim Se-Mi),이윤정(Lee Yun-Jung) 학습자중심교과교육학회 2021 학습자중심교과교육연구 Vol.21 No.24

목적 본 연구에서는 유아 교사들의 유아교육현장에서의 사회적 소수자에 대한 인식을 알아보고, 이를 토대로 유아 교사의 사회적 소수자에 대한 인식 개선을 위한 시사점을 도출하는데 목적이 있다. 방법 연구 참여자는 8명의 유아 교사로 눈덩이 표집방법으로 선정하였으며, 2019년 7월부터 9월까지 반구조화된 질문지로 심층 면담을 진행하였다. 자료 분석은 Glaser & Strauss(1967)의 분석적 귀납 방법을 근거로 개방적 코당을 활용하여, 개념의 명명화, 범주 배치, 범주 간의 재조합, 핵심범주 도출, 유형화 단계를 거쳐 분석하였다. 결과 유아교육 현장에서 유아 교사의 사회적 소수자에 대한 인식은 첫째, 유아 교사는 사회적 소수자를 보는 관점이 다양하여, 사회적 소수자를 도움을 줘야하는 보호대상이나 피하고 싶은 대상으로 상반된 인식을 가지고 있었다. 둘째, 유아 교사들은 자신도 상황에 따라 사회적 소수자일 수 있다는 경험이 소수자에 대한 인식에 변화를 가져왔다. 셋째, 유아 교사는 교육 현장에서의 경험을 통해 사회적 소수자에 대한 인식이 긍정적으로 변하였고, 사회적 소수자를 위한 활동을 할 때 보람을 가졌다. 넷째, 유아 교사는 유아교육 현장에서 사회적 소수자 지도에 따른 과잉 업무와 이들을 위한 지나친 배려의 역차별성 가능성을 지적하였다. 다섯째, 유아 교사들의 사회적 소수자에 대한 인식 개선을 위해서는 유아 교사들을 대상으로 하는 사회적 소수자 이해교육 강화, 부모와의 소통, 예비 유아 교사의 사회적 소수자에 대한 의무 교육 실시, 누리과정에서의 사회적 소수자 내용 보완, 사회적 소수자를 위한 사회적 지원을 필요로 하였다. 결론 유아 교사의 사회적 소수자에 대한 인식은 다양한 관점을 가지고 있었으나, 현장에서의 경험과 교육읕 통해서 긍정적으로 전환됨 볼 수 있었으며, 인식 개선 방안으로는 유아 교사의 사회적 소수자에 대한 지속적인 교육 강화와 사회적 소수자를 반영하는 누리과정 보완과 예비 유아 교사를 대상으로하는 사회적 소수자 교육이 필요함을 알 수 있었다. Objectives This study aims to investigate early childhood teacher’s perception on children in social minority group and to develop measures for improvement of their perception and education. Methods After eight teachers were selected by snowball sampling method at an early childhood education institution. in-depth interview were conducted from July 2019 to September 2019 from which data analysis was performed, based on analytical induction method of Glaser & Strauss(1967). Results First, the teachers have so diverse perception on the children in social minority, imlpying for necessity to expand and clarify their perceptions. Second the participants had both burden on and excitement of teaching the children in social minority. Third, teachers’ persornal experiences as social minorities changed their perceptions of children in the social minority group. Fourth, they pointed out over-burden on the teachers to take care of the minority children and potential risk of reverse discrimination against normal children arising about of too much care for the minority group. Fifth, they noted that teachers’ perception bias could be alleviated or removed by further education of teachers on how to understand minority students. commnication with parents, compulsory education of the prospective teachers with respect to minority students, revision of the Nuri curriculum on minority students, and social support for the minority group. Conclusions Diverse perceptions of teachers on minority students could be positively turned by onsite experiences of teaching the children, and also by continuing education of teachers, revising the Nuri education program, and introducing a new teacher development program covering minority education.

Effects of Molecular Weight of PC on Thermal Properties of PC/ABS Blends Using High-Shear Rate Processing

Se Mi Kim(김세미),Hee Jung Park(박희정),Eun Ju Lee(이은주),Seung Goo Lee(이승구),Kee Yoon Lee(이기윤) 한국고분자학회 2018 폴리머 Vol.42 No.4

ABS(acrylonitrile-butadiene-styrene)와 분자량이 다른 2종의 PC(polycarbonate)를 블렌딩하고, 고속전단압출성형기를 사용하였을 때 고속 전단에 의한 PC 분자량에 따른 열적 물성의 변화를 연구하였다. DSC(differential scanning calorimetry)와 TGA(thermogravimetric analysis)를 이용하여 유리전이온도와 열분해온도를 각각 측정하였다. 가해지는 전단력을 증가시킬 때에는 PC1(MW=13700)/ABS와 PC2(MW=9700)/ABS 두 가지 경우 모두 유리전이온도가 감소하는 동일한 경향을 보였다. TGA의 경우 전단력을 가하지 않은 경우 명확한 두 단계의 분해곡선을 나타내고, 고속 전단 가공을 한 경우 분해곡선이 선형으로 변화하는 경향을 보였다. 또한 고분자량의 PC를 사용한 PC/ABS 블렌드의 경우 저분자량의 PC를 사용한 경우보다 높은 유리전이온도와 열분해온도를 나타내었다. 이를 통하여 고속 전단 압출을 이용하여 상용성을 향상시킬 수 있으나 3000 rpm 이상의 고속전단을 가하면 블렌드 내의 열화가 발생한다는 것을 알 수 있었다. Each of the two polycarbonates (PC) of different molecular weights was blended with acrylonitrile-butadienestyrene (ABS) to afford PC/ABS which was processed at several high-shear rates in order to study thermal behaviors. Changes in glass transition temperatures (Tgs) and thermal degradation behavior were measured by differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA), respectively. Tgs of both PC1 (MW=13700)/ABS and PC2 (MW=9700)/ABS gradually decreased as high-shear rate increased. Tg of PC1/ABS was higher than that of PC2/ABS at each condition of high-shear rate. PC/ABS without shear processing showed two TGA peaks which coalesced into one as high-shear rate was increased. The results indicated that high-shear rate processing could be utilized to improve compatibilities between blending mixtures but suffered from the disadvantages of thermal degradations above 3000 rpm and 20 s of high-shear rates.

영화 영한 자막 번역에 나타난 퀴어 인식에 대한 변화

김세미(Se Mi, Kim) 동국대학교 영상문화콘텐츠연구원 2023 영상문화콘텐츠연구 Vol.30 No.-