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Bioequivalence of Rispen Tablet to Risperdal Tablet (Risperidone 2 mg) (리스페달 정(리스페리돈 2mg)에 대한 리스펜 정의 생물학적 동등성)

  • Cho, Hea-Young;Park, Eun-Ja;Kang, Hyun-Ah;Baek, Seung-Hee;Lee, Suk;Park, Chan-Ho;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.34 no.2
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    • pp.139-145
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    • 2004
  • The purpose of the present study was to evaluate the bioequivalence of two risperidone tablets, Risperdal (Janssen Korea Co., Ltd.) and Rispen (Myung In Pharm. Co., Ltd), according to the guidelines of Korea Food and Drug Administration (KFDA). The risperidone release from the two risperidone formulations in vitro was tested using KP VIII Apparatus II method with various of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty four healthy male subjects, $23.33\;{\pm}2.10$ years in age and $69.24{\pm}8.05\;kg$ kg in body weight, were divided into two groups and a randomized $2\;{\times}\;2$ cross over study was employed. After one tablet containing 2 mg as risperidone was orally administered, blood was taken at predetermined time intervals and the concentrations of risperidone in serum were determined using HPLC method with UV detector. The dissolution profiles of two formulations were similar at all dissolution media. Besides, the pharmacokinetic parameters such as $AUC_t$,$C_{max},\;and\;T_{max}$ were calculated and ANOVA test was utilized for the 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 Risperdal were 0.20, -1.29 and -11-09% for $AUC_t$,$C_{max},\;and\;T_{max}$, respectively There were no sequence effects two formulations in parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) (e.g.,$log(0.90){\sim}log(1.30)$ and $log(0.84){\sim}log(1.09)$ for$AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA guideline for the bioequivalence were satisfied, indicating Rispen tablet and Risperdal tablet were bioequivalent.

Bioequivalence of Glimed Tablet to Amaryl Tablet (Glimepiride 2 mg) (아마릴 정(글리메피리드 2mg)에 대한 글리메드 정의 생물학적 동등성)

  • Cho, Hea-Young;Park, Eun-Ja;Kang, Hyun-Ah;Baek, Seung-Hee;Lee, Suk;Kim, Se-Mi;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.34 no.2
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    • pp.147-153
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    • 2004
  • The purpose of the present study was to evaluate the bioequivalence of two glimepiride tablets, $Amaryl^{\circledR}$ (Handok/Aventis Pharm. Co., Ltd.) and Glimed (Kuhn II Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The glimepiride release from the two glimepiride formulations in vitro was tested using KP VIII Apparatus II method with a variety of dissolution media (pH 1.2, 4.0, 6.8 buffer solution, water and blend of PSB 80 into each dissolution medium). Twenty six healthy male subjects, $22.65{\pm}2.19$ years in age and $66.55{\pm}8.85$ kg in body weight, were divided into two groups and a randomized $2\;{\times}\;2$ cross-over study was employed. After one tablet containing 2 mg as glimepiride was orally administered, blood was taken at predetermined time intervals and the concentrations of glimepiride in serum were determined using HPLC method with UV detector. The dissolution profiles of two formulations were similar at all dissolution media. Besides, 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 Amaryl were -3.70, -8.28 and 0.61% 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., $log(0.84){\sim}log(1.04)$ for $log(0.82){\sim}log(1.03)$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA guideline for the bioequivalence were satisfied, indicating Glimed tablet and Amaryl tablet were bioequivalent.

Bioequivalence of Tagamet Tablet to Sinil CIMETIDINE Tablet (cimetidine 400 mg) (타가메트정 400 mg에 대한 신일시메티딘정 400 mg의 생물학적동등성시험)

  • Yoon, Mi-Kyeong;Lee, Byoung-Moo;Lee, Sung-Jae;Kim, Sun-Kyu;Lee, Jae-Hwi;Choi, Young-Wook
    • Journal of Pharmaceutical Investigation
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    • v.34 no.6
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    • pp.521-527
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    • 2004
  • Cimetidine is a histamine $H_2-receptor$ antagonist, used for the treatment of endoscopically or radiographically comfirmed duodenal ulcer, pathologic GI hypersecretory conditions, and active, benign and gastric ulcer. Simple method for determining cimetidine in human plasma has been developed and validated. The analytical procedure for cimetidine showed a linear relationship in the concentration ranges from $0.05\;to\;5\;{\mu}g/ml$. Coefficient of variance (CV, %) for intraday and interday validation and relative error (RE, %) were less than ${\pm}15%$. Based on this analytical method, the bioequivalence of two cimetidine 400 mg tablets, reference (Tagamet 400 mg) and test drug (Sinil CIMETIDINE 400 mg) was evaluated according to the guidelines set by the Korea Food and Drug Administration (KFDA). Release of cimetidine from the tablets in vitro was tested using KP VIII Apparatus II with various dissolution media (pH 1.2, 4.0, 6.8 buffer solutions and water). Twenty-four healthy volunteers, $21.38{\pm}1.86$ years in age and $68.71{\pm}8.68\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was performed. After oral administration of a tablet containing 400 mg of cimetidine, blood samples were taken at predetermined time intervals and concentrations of cimetidine in plasma were determined using HPLC equipped with UV detector. The dissolution profiles of the two tablet formulations were very similar at all dissolution media. In addition, pharmacokinetic parameters such as $AUC_t$ and $C_{max}$ were calculated and ANOVA was employed for the statistical analysis of parameters. The results were revealed that the differences in $AUC_t$ and $C_{max}$ between the two tablets were 4.17 % and 0.97% respectively. At 90% confidence intervals, the differences in these parameters were also within ${\pm}20%$. All of the above mentioned parameters have met the criteria of KFDA guidelines for bioequivalence, indicating that the test drug tablet (Sinil CIMETIDINE tablet) is bioequivalent to Tagamet 400 mg tablet.

Design of Experiment and Analysis Method for the Integrated Logistics System Using Orthogonal Array (직교배열을 이용한 통합물류시스템의 실험 설계 및 분석방법)

  • Park, Youl-Kee;Um, In-Sup;Lee, Hong-Chul
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.12 no.12
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    • pp.5622-5632
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    • 2011
  • This paper presents the simulation design and analysis of Integrated Logistics System(ILS) which is operated by using the AGV(Automated Guided Vehicle). To maximize the operation performances of ILS with AGV, many parameters should be considered such as the number, velocity, and dispatching rule of AGV, part types, scheduling, and buffer sizes. We established the design of experiment in a way of Orthogonal Array in order to consider (1)maximizing the throughput; (2)maximizing the vehicle utilization; (3)minimizing the congestion; and (4)maximizing the Automated Storage and Retrieval System(AS/RS) utilization among various critical factors. Furthermore, we performed the optimization by using the simulation-based analysis and Evolution Strategy(ES). As a result, Orthogonal Array which is conducted far fewer than ES significantly saved not only the time but the same outcome when compared after validation test on the result from the two methods. Therefore, this approach ensures the confidence and provides better process for quick analysis by specifying exact experiment outcome even though it provides small number of experiment.

Immobilization of $\beta-galactosidase$ with High Transgalactosylation Activity from Bacillus sp. A4442 Mutant (변이주 Bacillus sp. A4442가 생산하는 갈락토스 전이활성이 높은 $\beta-galactosidase$의 고정화)

  • Kim, Min-Hong;Jung, Jin;In, Man-Jin
    • Applied Biological Chemistry
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    • v.39 no.5
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    • pp.333-337
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    • 1996
  • For continuous production of galactooligosaccharides(GOS), $\beta-galactosidase$ with h1gh transgalactosylation activity from Bacillus sp. A 4442 was Immobilized onto $Diaion^{TM}$ HPA 75(styrene-divinylbenzene resin). The parameters influencing enzyme immobilization were scrutinized in order to maximize immobilization yield while minimizing enzyme inactivation. The optimum conditions turned out to be: Tris buffer concentration 30 mM, pH 8.0, contact time at room temperature 3 hr, and enzyme loading 25 mg protein/g resin. Both the thermal stability and the operational stability of immobilized enzyme were markedly enchanced by the treatment with 0.5% glutaraldehyde as a cross-linker. Under the experimental conditions established, the yield of ${\beta}-galactosidase$ immobilization was 40% or more and the activity of the immobilized enzyme ca. 200 U/g resin. When a packed-bed reactor was employed to continuously convert lactose to GOS, the specific production, which refers to as the amount of commercially valuable GOS produced by a unit amount of immobilized ${\beta}-galactosidase$, was found to be ca. 300 g GOS/g carrier.

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Scheduling System using CSP leer Effective Assignment of Repair Warrant Job (효율적인 A/S작업 배정을 위한 CSP기반의 스케줄링 시스템)

  • 심명수;조근식
    • Proceedings of the Korea Inteligent Information System Society Conference
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    • 2000.11a
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    • pp.247-256
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    • 2000
  • 오늘날의 기업은 상품을 판매하는 것 뿐만 아니라 기업의 신용과 이미지를 위해 그 상품에 대한 사후처리(After Service) 업무에 많은 투자를 하고 있다. 이러한 양질의 사후서비스를 고객에게 공급하기 위해서는 많은 인력을 합리적으로 관리해야 하고 요청되는 고장수리 서비스 업무를 빠르게 해결하기 위해서는 업무를 인력들에게 합리적으로 배정을 하고 회사의 비용을 최소화하면서 정해진 시간에 요청된 작업을 처리하기 위해서는 인력들에게 작업을 배정하고 스케줄링하는 문제가 발생된다. 본 논문에서는 이러한 문제를 해결하기 위해 화학계기의 A/S 작업을 인력에게 합리적으로 배정하는 스케줄링 시스템에 관한 연구이다. 먼저 스케줄링 모델을 HP 사의 화학분석 및 시스템을 판매, 유지보수 해 주는 "영진과학(주)"회사의 작업 스케줄을 분석하여 필요한 도메인과 고객서비스전략과 인력관리전략에서 제약조건을 추출하였고 여기에 스케줄링 문제를 해결하기 위한 방법으로 제약만족문제(CSP) 해결기법인 도메인 여과기법을 적용하였다. 도메인 여과기법은 제약조건에 의해 변수가 갖는 도메인의 불필요한 부분을 여과하는 것으로 제약조건과 관련되어 있는 변수의 도메인이 축소되는 것이다. 또한, 스케줄링을 하는데에 있어서 비용적인 측면에서의 스케줄링방법과 고객 만족도에서의 스케줄링 방법을 비교하여 가장 이상적인 해를 찾는데 트래이드오프(Trade-off)를 이용하여 최적의 해를 구했으며 실험을 통해 인력에게 더욱 효율적으로 작업들을 배정 할 수 있었고 또한, 정해진 시간에 많은 작업을 처리 할 수 있었으며 작업을 처리하는데 있어 소요되는 비용을 감소하는 결과를 얻을 수 있었다. 검증하였다.를, 지지도(support), 신뢰도(confidence), 리프트(lift), 컨빅션(conviction)등의 관계를 통해 다양한 방법으로 모색해본다. 이 연구에서 제안하는 이러한 개념계층상의 흥미로운 부분의 탐색은, 전자 상거래에서의 CRM(Customer Relationship Management)나 틈새시장(niche market) 마케팅 등에 적용가능하리라 여겨진다.선의 효과가 나타났다. 표본기업들을 훈련과 시험용으로 구분하여 분석한 결과는 전체적으로 재무/비재무적 지표를 고려한 인공신경망기법의 예측적중률이 높은 것으로 나타났다. 즉, 로지스틱회귀 분석의 재무적 지표모형은 훈련, 시험용이 84.45%, 85.10%인 반면, 재무/비재무적 지표모형은 84.45%, 85.08%로서 거의 동일한 예측적중률을 가졌으나 인공신경망기법 분석에서는 재무적 지표모형이 92.23%, 85.10%인 반면, 재무/비재무적 지표모형에서는 91.12%, 88.06%로서 향상된 예측적중률을 나타내었다.ting LMS according to increasing the step-size parameter $\mu$ in the experimentally computed. learning curve. Also we find that convergence speed of proposed algorithm is increased by (B+1) time proportional to B which B is the number of recycled data buffer without complexity

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IDENTIFICATION OF PORPHYROMONAS ENDODONTALIS USING POLYMERASE CHAIN REACTION(RCR) (중합효소연쇄반응(Polymerase Chain Reaction)을 이용한 Porphyromonas endodontalis의 동정에 대한 연구)

  • Lee, Sang-Yup;Yoon, Soo-Han
    • Restorative Dentistry and Endodontics
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    • v.23 no.1
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    • pp.328-338
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    • 1998
  • Porphyromonas endodontalis, an anaerobic Gram negative cocobacillus which was known to be associated with the infected root canals and periapical lesions, is very difficult to culture and to detect by the traditional method in that it requires much time to induce the specific black pigmentation, and it is very sensitive to oxygen and the antibiotics added in the culture medium. In this study, the nucleotide sequences of the 'probe h' (0.73kb), one of the specific DNA probes top. endodontalis (ATCC 35406) which had been developed by our department, was determined and then a pair of primers for PCR amplification was fabricated to identify P. endodontalis. The plasmids containing 'probe h' were purified by $Wizard^{TM}$ Midipreps DNA Purification System (Promega Corp.), and the nucleotide sequences of the 'probe h' were determined by the dideoxy chain termination method using TaqTrack Sequencing System (Promega Corp.) and detected by fluorescent labelling method. The sense/antisense PCR primers were designed with computer software (Lasergene, DNASTAR Ind. PCR was done with a programmable GeneAmp PCR System 2400 (Perkin Elmer-Cetus Co.). Each sample containing the whole genomic DNA of P. endodontalis and other black-pigmented Bacteroides was itailly denatured at $94^{\circ}C$ for 5 min and then subjected to 30 cycles, each of them consisting of 60s at $94^{\circ}C$, 60s at $60^{\circ}C$, and 90s. at $72^{\circ}C$. The amplified DNA was resolved electrophoretically in a 1.0 % agarose gel in 1X TAE buffer, stained with EtBr, and photographed on a UV transilluminator. The results were as follows : 1. The nucleotide sequences of 'probe h' (743 base pairs) were obtained by dideoxy chain termination method, and from that results the specific primers to P. endodontalis (ATCC 35406), 'Primer H1/ Primer H2', were designed. 2. It has been found that 'Primer H1/H2' could detect P. endodontalis (ATCC 35406) using PCR. 3. The PCR system with this primers may be a powerful technique to amplify the specific sequences of 'probe h' of P. endodontalis (ATCC 35406) that produce distinct identification of it from other black-pigmented Bacteroides, and this could help us to determine the nature of periapical disease.

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Bioequivalence Test of Gabapentin 400 mg Capsules (가바펜틴 400밀리그람 캡슐의 생물학적동등성시험)

  • Kim, Se-Mi;Kang, Hyun-Ah;Cho, Hea-Young;Shin, Sae-Byeok;Yoo, Hee-Doo;Yoon, Hwa;Lee, Yong-Bok
    • YAKHAK HOEJI
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    • v.52 no.3
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    • pp.195-200
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    • 2008
  • 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.

Two Economic Crises, Unemployment, Working Poor, and Gender: Explaining the Dynamics of the Risk Patterns of Suicide in South Korea (두 번의 경제위기와 실업, 노동빈곤, 그리고 젠더: 한국 자살 위험양식의 역동적 변화에 대한 시론)

  • Moon, Dasuel;Chung, Haejoo
    • 한국사회정책
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    • v.25 no.4
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    • pp.233-263
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    • 2018
  • This study sought to identify gender-specific mechanisms of increased suicide rates during economic crises in South Korea. In order to address research aims, we focused on two international economic crises: IMF financial crisis in 1997, and international recession in 2008. This study provides three main findings. First, different mechanisms increased suicide rates during the two economic crises. Particularly, the high level of unemployment raised suicide rates during the 1997 IMF while the high level of working poor in the 2008 recession. Second, suicidal risk patterns for men and women differed at each period. The 1997 crisis which mostly affected full-time permanent workers had had relatively greater impacts on men suicide, whereas the 2008 crisis which affected precarious workers had done on women suicide. Finally, our finding indicated that these gender-specific risk patterns had been derived from the gendered labour market and male-friendly social policy. Placing women at the periphery of the labor market and using them as a buffer in times of crisis, governments failed to protect them from their economic difficulties. Suicide is fundamental and important public health and social problems. These findings suggest that the national suicide prevention strategy should pay attention to the social determinants of suicide through gendered as well as population health perspectives.

Bridge Employment and Changes in Marital Satisfaction among Korean Baby Boomers (가교일자리에서의 근로가 베이비부머의 결혼만족도 변화에 미치는 영향)

  • Nah, Su-young;Han, Gyoung-hae
    • 한국노년학
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    • v.36 no.3
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    • pp.541-562
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    • 2016
  • The current study investigates the relationship and the mechanisms between bridge employment and change in marital satisfaction during midlife, using a three-wave panel dataset obtained from the Korean Baby Boomer Panel Study. A multivariate latent growth analysis reveals that the transition from career employment to bridge employment, compared to maintaining career employment, has an indirect negative effect on increase rate of marital satisfaction through the wage decrease. A steep decrease in wage following transition to bridge employment causes a lower increase in marital satisfaction. On the other hand, continuously engaging in bridge employment rather than career employment is associated with a higher increase in marital satisfaction via a higher increase in job commitment. This result implies that Baby Boomers adapt to bridge employment over time. Overall, the present study finds that the effect of bridge employment on the change in marital satisfaction during midlife varies with the duration of bridge employment. A future research needs to explore which factors can buffer the negative effect of decrease in wage during transition to the bridge employment on the change in marital satisfaction.