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.

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.

Antitumor Activity of LB42907, a Potent and Selective Farnesyltransferase Inhibitor: Synergistic Effect in Combination with Other Anticancer Drugs

김세미,Ji Hyun Park,Sun-Young Koo,김동명,Kwihwa Kim,Shin Wu Jeong,Hyun-Ho Chung,Heung-Soo Cho,Joonghoon Park,Hyeon Joo Yim,Jinho Lee,Jong Sung Koh 대한화학회 2008 Bulletin of the Korean Chemical Society Vol.29 No.7

Inhibitors of farnesyltransferase (FT), a key enzyme in the post-translational modifications of Ras proteins, have been extensively studied as novel anticancer agents in the preclinical stages, some of which are currently in clinical development. Previously, it has been reported that a novel FT inhibitor LB42907 inhibits Ras farnesylation in the nanomolar range in vitro. The aim of this study was to assess the antitumor efficacy of LB42907 in vitro and in vivo. Anchorage-independent growth of various human tumor cell lines was potently inhibited by treatment with LB42907, comparable to other FT inhibitors in clinical development. In the nude mouse, oral administration of LB42907 demonstrated potent antitumor activity in several human tumor xenograft models including bladder, lung and pancreas origin. Interestingly, significant tumor regression in EJ (bladder) and A549 (lung) xenografts was induced by LB42907 treatment. The effectiveness of LB42907 was also investigated in simultaneous combination with paclitaxel, vincristine, cisplatin or gemcitabine against NCI-H460, A549, and HCT116 cells in vitro using median-effect analysis. LB42907 markedly synergized with most anticancer drugs tested in this study in NCI-H460 cell. In contrast, LB42907 displayed antagonism or partial synergism with these drugs in A549 and HCT116 cells, depending on the class of combined drugs and/ or the level of cytotoxicity. Our results demonstrate that LB42907 is an effective antitumor agent in vitro and in vivo and combination of LB42907 with other chemotherapeutic drugs results in synergistic or antagonistic effects mainly in a cell line-dependent manner. Further preclinical study is warranted.

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 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.

현대중국어 시량사와 빈어의 어순 제약요소 연구

金世美(Kim, Se-mi) 중국어문학연구회 2016 중국어문학논집 Vol.0 No.97

This research analyzes the word order when time measure word and objects are used, and identifies key factors to restrict the word order. Generally, sentences with time measure word and object after verb is divided into 3 types; 1. V+T+N 2. V+N+T and V+N+V+T. Verb, object, time measure word and pragmatics constrains should be considered when choosing the word order. This research accounts for the factors in 2 ways. First, it will be examined that how the feature of persistency of verb can influence time measure word and object. Specifically, persistency of verb are classified into 4 types; Non-persistent, Strong-persistent, Weak-Persistent and state-persistent and difference of the verbs is analyzed. Second, it will be analyzed that how types of objects restrict word of order when time measure word and object is used. Frequency of object and time measure word is analyzed by dividing object into personal pronoun, general noun, quantifier.

안경사의 음주 및 흡연 실태와 직무스트레스 관계 분석: 수도권(서울, 경기, 인천)지역을 중심으로

김세미(Semi Kim),안지혜(Jihye Ahn),최문성(Moonsung Choi) 한국안광학회 2020 한국안광학회지 Vol.25 No.3

복합형 회전익기의 덕티드팬 기동제어용 베인 공력특성 연구

김세미(Semi Kim),강동훈(Donghun Kang),홍슬기(Seulki Hong),최재호(Jaeho Choi),강인모(In-Mo Kang),유흥철(Heung-Cheol You) 한국항공우주학회 2019 한국항공우주학회 학술발표회 논문집 Vol.2019 No.11

터보펌프 인듀서의 흡입성능 및 캐비테이션 변화에 대한 수치해석 연구

김세미(Semi Kim),최창호(Changho Choi),김진한(Jinhan Kim),박준영(Junyoung Park),백제현(Jehyun Baek) 대한기계학회 2013 대한기계학회 춘추학술대회 Vol.2013 No.5

현대중국어 시량사구 어순에 반영된 도상성 고찰

金世美(Kim, Se-mi) 중국어문학연구회 2016 중국어문학논집 Vol.0 No.101

The purpose of this paper is to interpret diverse word order of temporal quantity phrases from the perspective of cognitive iconicity. Generally, the sentence with both temporal quantity word and object is categorized into the three types - ‘V+N+T’, ‘V+T+N’, and ‘V+N+V+T.’ Such phrases describe the passage of time after the end of act, duration of action or status. Diverse word order of temporal quantity phrases reflects the way we perceive the reality. More specifically, this paper concludes that the Principle of Temporal Sequence and Influence Iconicity are reflected in the word order of temporal quantity phrases. First, the Principle of Temporal Sequence means that the time order of events follows the order of language structure. This paper examines the Principle of Temporal Sequence reflected in the word order of ‘V+N+T’, ‘V+T+N’, and ‘V+N+V+T’ sentence structures. Next, the Influence Iconicity means the word order differs due to influence of verbs on grammar constituents. In this paper, verbs are divided into Strong-persistent, Weak-persistent and Non-persistent verbs according to traits of persistency. How the influence of persistency is reflected in the word order is also clarified.