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Bioequivalence of Cadilan Tablet 12.5 mg to Dilatrend® Tablet 12.5 mg (Carvedilol 12.5 mg) (딜라트렌 정 12.5밀리그람(카르베딜롤 12.5밀리그람)에 대한 카딜란 정 12.5밀리그람의 생물학적동등성)

  • Kim, Se-Mi;Shin, Sae-Byeok;Kim, Ju-Hwan;Kwon, In-Ho;Kim, Yong-Hee;Lee, Sang-No;Cho, Hea-Young;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.38 no.6
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    • pp.413-419
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    • 2008
  • Carvedilol, is a nonselective $\beta$-blocking agent and it also has vasodilating properties that are attributed mainly to its blocking activity at ${\alpha}_1$-receptors. The purpose of the present study was to evaluate the bioequivalence of two carvedilol tablets, $Dilatrend^{(R)}$ tablet 12.5 mg (Chong Kun Dang Pharmaceutical Co., Ltd.) and Cadilan tablet 12.5 mg (KyungDong Pharmaceutical. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of carvedilol from the two carvedilol formulations in vitro was tested using KP VIII Apparatus II method with pH 4.5 dissolution medium. Thirty two healthy male subjects, $25.00{\pm}3.09$ years in age and $70.71{\pm}11.35\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 12.5 mg as carvedilol was orally administered, blood samples were taken at predetermined time intervals and the concentrations of carvedilol in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar in the tested dissolution medium. 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, $Dilatrend^{(R)}$ tablet 12.5 mg, were 4.66%, 8.33% and -7.45% 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., $\log\;0.9823{\sim}\log\;1.1042$ and $\log\;1.0132{\sim}\log\;1.1875$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Cadilan tablet 12.5 mg was bioequivalent to $Dilatrend^{(R)}$ tablet 12.5 mg.

Prevention of Swelling and Quality Improvement of Sunchang Traditional Kochujang by Natural Additives (천연첨가물을 이용한 전통고추장의 유통중 팽창억제 및 품질개선)

  • 정도연;송미란;신동화
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.30 no.4
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    • pp.605-610
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    • 2001
  • To suppress the gas forming caused by some yeast in the pack of traditional kochujang prepared at Sunchang area, which is the most severe problem during distribution of commercial products, mustard or horseradish powder as natural preservatives was mixed to the ingredients of kochujang and left for fermentation in clay pot as commercial scale for 180 day. The composition changes including quality and gas formaing in the kochujang containing those additives were monitored physicochemically and organoleptically. The fermented kochujang containing those additives were monitored physicohemically and organoleptically. The fermented kochujang containing 0.6% of horseradish showed lower organic acid content than that of the control but amino type nitrogen content, which is one of the important quality reference of kochujang, was higher in the one containing 0.6% natural preservatives. No color changed in the kochujang containing mustard but L and a value were increased in the kochujang containing horseradish. No difference of free reducing sugars was showed by the addition of those natural preservatives and the addition of 0.6% horseradish to kochujang had completely stopped gas forming during fermentation. The overall quality of the kochujang containing 0.6% horseradish was superior than that of the other treatments.

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Pharyngeal airway analysis of different craniofacial morphology using cone-beam computed tomography (CBCT) (Cone beam CT를 이용한 안면골격형태에 따른 상기도 공간 분석)

  • Kim, Yong-Il;Kim, Seong-Sik;Son, Woo-Sung;Park, Soo-Byung
    • The korean journal of orthodontics
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    • v.39 no.3
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    • pp.136-145
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    • 2009
  • Objective: CBCT has become popular for orthodontic diagnosis and treatment planning in recent times. The 3D pharyngeal airway space needs to be analysed using a 3D diagnostic tool. The aim of this study was to analyse the pharyngeal airway of different craniofacial morphology using CBCT. Methods: The sample compromised 102 subjects divided into 3 groups (Class I, II, III) and 6 subgroups according to normal or vertical craniofacial patterns. All samples had CBCT (VCT, Vatech, Seoul, Korea) taken for orthodontic treatment. The pharyngeal airway was assessed according to the reference planes: aa plane (the most anterior point on the anterior arch of atlas), $CV_2$ plane, and $CV_3$ plane (most infero-anterior point on the body of the second & third cervical vertebra). The intergroup comparison was performed with one-way ANOVA and duncan test as a second step. Results: The results showed the pharyngeal airway and anteroposterior width of group 2 (Class II) in aa plane, $CV_2$ plane, $CV_3$ plane were significant narrower than in group 3 (Class III). There was no significant difference between vertical and normal craniofacial patterns except for the anteroposterior pharyngeal width of Group 1 (Class I) in aa plane. Conclusions: Subjects with Class II patterns have a significantly narrower pharyngeal airway than those with Class III. However there was no difference in pharyngeal airway between vertical and normal craniofacial morphology.

A comparative study of periodontal conditions around mesially tipped molars by a tipping degree (대구치의 근심 경사 정도에 따른 치주 상태의 비교 연구)

  • Park, So-Young;Choi, Seoung-Hwan;Lee, Su-Jeong;Chang, Moon-Taek;Kim, Hyung-Seop
    • Journal of Periodontal and Implant Science
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    • v.32 no.1
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    • pp.41-49
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    • 2002
  • The aim of this study was to compare periodontal conditions around mesially tipped molars by a tipping degree. Patients who had been consecutively treated at the Department of Periodontology, Chonbuk National University Hospital from October 1999 to August 2001 were assessed with radiographs taken at their molar regions. Of all molars investigated, 142 molars of 116 patients tipped mesially more than 10 degrees to the line perpendicular to an occlusal plane were selected for the study. The tipped molars were divided into 2 groups with a reference to a tipping degree, i.e., 66 slightly tipped(group 1 : <$30^{\circ}$) and 76 severely tipped molars (group 2 : ${\geq}30^{\circ}$). Probing depth(PD), plaque retention index(PRI) at mesial surfaces of tipped molars and tooth mobility(TM) were recorded at the clinical examination. Tipping degree(TD) and alveolar bony defect(ABD) at the mesial surface of the molars were measured in a radiograph. The results showed that no statistical differences were found between groups in all measured variables. In Pearson correlation analysis performed in the same group, a positive relationship was shown between PRI and PD in the group 1 and, in the group 2, between PRI and PD as well as PRI and ABD(p < 0.01). However, no statistically significant relationship was found between TD and all other variables in both groups. Within limitations of this study, it may be concluded that tipping degree did not seem to influence periodontal conditions, i.e., PD, ABD and TM of mesially tipped molars per se, but plaque presence/absence seemed to mainly affect the periodontal conditions of the tipped molars.

An Electrophysiologic Study on the Ulnar Digital Nerves (척골 지단 신경의 전기생리학적 연구)

  • Kim, Jong-Soon;Lee, Hyun-Ok;Ahn, So-Youn;Koo, Bong-Oh;Nam, Kun-Woo;Kim, Ho-Bong;Ryu, Jae-Kwan;Ryu, Jae-Moon
    • The Journal of Korean Academy of Orthopedic Manual Physical Therapy
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    • v.11 no.2
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    • pp.13-18
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    • 2005
  • The ulnar nerve extends down the arm, across the elbow, and into the hand. It provides sensation to the little and ring fingers and activates many of the small muscles in the hand. The determination of peripheral nerve conduction velocity is an important part of ulnar nerve evaluation. The electrodiagnostic value as neurophysiologic investigative procedure has been known for many years but normal value of digital nerve was not reported in Korea. The purpose of this investigation was to measure the digital nerve conduction velocity of ulnar nerve for obtain clinically useful reference value and compare difference in each fingers and then compare with the other countries. 71 normal Korean volunteers (age, 19-65 years; 142 hands) examined who has no history of peripheral neuropathy, diabetic mellitus, chronic renal failure, endocrine disorders, anti-cancer medicine, anti-tubercle medicine, alcoholism, trauma, radiculopathy. Nicolet Viking II (EMG machine) was use for detected conduction velocity and amplitude of digital nerves in ulnar nerve. Data analysis was performed using SPSS. Descriptive analysis was used for obtain mean and standard deviation and independent t-test was used to compare with ring and little finger. Conduction velocity of the right ring finger was 57.44m/sec and little finger was 55.32msec. The left ring finger was 55.55msec and little finger was 54.11msec. Amplitude of the right ring finger was $30.28{\mu}V$ and little finger was $48.36{\mu}V$. The left ring finger was $30.67{\mu}V$ and little finger was $52.76{\mu}V$. There were significantly difference between ring and little in amplitude (p<.05) but there were no statistically difference between conduction velocity of ring and little finger (p>.05). The amplitude of little finger are greater than ring finger. The present results revealed that electodiagnosis can easily perform in little finger for digital nerve of ulnar nerve study.

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Case Study on Treaty-Based Investor-State Arbitration and Environmental Litigations with Specific Reference to Chevron/Ecuador Litigation (환경 소송과 국제투자중재 - 쉐브론 사건을 중심으로)

  • Kang, Pyoung-Keun
    • Journal of Arbitration Studies
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    • v.25 no.4
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    • pp.3-23
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    • 2015
  • The Chevron saga including Chevron/TexPet v. Ecuador, PCA Case No. 34877(hereinafter referred to as "Chevron I") and Chevron/TexPet v. Ecuador, PCA Case No. 2009-23(hereinafter referred to as "Chevron II") started out of domestic litigations between TexPet and Ecuador in the early 1990s. In Chevron I, the Tribunal decided that Article 2(7) of the U.S.-Ecuador BIT on effective means of provision was breached because of undue delays in the seven legal proceedings TexPet had brought against Ecuador in respect to contractual obligations. In Chevron II, it was contended that through the actions and inactions of the judiciary and the executive, Ecuador breached her several obligations under the BIT. Ecuador objected to the jurisdiction of the Tribunal because TexPet's investment was terminated in 1992, and because Chevron is not a party to the 1995 Settlement Agreement and 1998 Final Release. In its Interim Award on Jurisdiction and Admissibility, the Tribunal applied a prima facie standard to the facts alleged by the Claimants but denied by the Respondent, and decided that questions in respect of the Respondent's jurisdictional objections should be joined to the merits under Article 21(4) of the UNCITRAL Arbitration Rules. In the merits phase of Chevron II, the Tribunal divided the merits of the Parties' dispute into two parts, entitled "Track 1" and "Track 2". In its Partial Award on Track 1, the Tribunal decided that Chevron is a "Releasee" under the 1995 Settlement Agreement. In a decision on "Track 1B", the Tribunal decided that the Lago Agrio complaint cannot be read as pleading "exclusively" or "only" diffuse claims, and that, to this extent, the Claimants' reliance on the 1995 Settlement Agreement as a complete bar to the Lago Agrio complaint must fail, as a matter of Ecuadorian law. The Tribunal maintained the position that the Parties' disputes on both merit and jurisdiction should be reserved for Track 2. It remains to be seen how the Tribunal addresses the Claimants' allegations of multiple denials of justice under international law against the judgments of the Respondent's Courts, together with the Respondent's jurisdictional objections in Track 2 of the arbitration.

Bioequivalence of Podox Tablet to Banan Tablet (Cefpodoxime Proxetil 100 mg) (바난 정(세프포독심 프록세틸 100mg)에 대한 포독스 정의 생물학적 동등성)

  • Cho, Seong-Wan;Lee, Ji-Hye;Song, Il-Yong;Lee, Sang-Kil;Cha, Young-Joo;Choi, Young-Wook
    • Journal of Pharmaceutical Investigation
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    • v.29 no.3
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    • pp.241-245
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    • 1999
  • Bioequivalence study of two cefpodoxime preparations, the test drug ($Banan^{\circledR}$: Hanil Pharmaceutical Co., Ltd.) and the reference drug ($Podox^{\circledR}$: Chong Kun Dang Pharmaceutical Co., Ltd.), was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen healthy male volunteers, $23.8{\pm}2.13$ years old and $63.34{\pm}4.84kg$ of body weight in average, were divided randomly into two groups and administered the drug orally at the dose of 200 mg as cefpodoxime proxetil in a $2{\times}2$ crossover study. Plasma concentrations of cefpodoxime were analysed by HPLC method for 12 hr after administration. The $AUC_{0-12hr}$ was calculated by the linear trapezoidal rule method. The $C_{max}$, and $T_{max}$ were compiled directly from the plasma drug concentration-time data. Student's t-test indicated no significant differences between the formulations in these parameters. Analysis of variance (ANOVA) revealed that there were no differences in AUC, $C_{max}$, and $T_{max}$ between the formulations. The apparent differences between the formulations were far less than 20% (e.g., 4.31, 1.99 and 4.30% for AUC, $C_{max}$, and $T_{max}$, respectively). Minimum detectable differences (%) between the formulations at ${\alpha}=\;0.05$ and $1-{\beta}=\;0.8$ were less than 20% (e.g., 13.89, 13.88, and 16.97% for AUC, $C_{max}$, and $T_{max}$, respectively). The 90% confidence intervals for these parameters were also within ${\times}20%$ (e.g., $-5,58{\sim}14.20$, $-7.89{\sim}11.88$, and $-7.78{\sim}16.38%$ for AUC, $C_{max}$, and $T_{max}$, respectively). These results satisfied the bioequivalence criteria of KFDA guidelines, indicating that the two formulations of cefpodoxime were bioequivalent.

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The Sampling Efficiencies of Volatile Organic Compounds(VOCs) to the Diffusive Monitor with Activated Carbon Fiber (활성탄섬유를 이용한 확산포집기의 공기 중 유기용제 포집효율에 관한 연구)

  • Byeon, Sang-Hoon;Park, Cheon-Jae;Oh, Se-Min;Lee, Chang-Ha
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.6 no.2
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    • pp.187-201
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    • 1996
  • This study was to evaluate the efficiency of diffusive monitor using activated carbon fiber(ACF, KF-1500) in measuring airborne organic solvents. The following characteristics were identified and studied as critical to the performance of diffusive monitor; recovery, sampling rate, face velocity, reverse diffusion and storage stability. For the evaluation of the performance of this monitor, MIBK, PCE, toluene were used as organic solvents. In the sampling rate experiments, eight kinds of solvents (n-hexane, MEK, DIBK, MCF, TCE, CB, xylene, cumene) as well as the above solvents were used. The results were as follows: 1. The desorption efficiencies(DE's) of ACF diffusive monitor ranged from 83 % to 101 %. In contrast, those of coconut shell charcoal ranged from 78 % to 102 %. Especially, the DE's of ACF for the polar solvents such as MEK were superior to those of charcoal. 2. Experimental sampling rates on ACF were average 42ml/min(37-46ml/min) for 11 organic solvents at $24{\pm}2^{\circ}C$, $50{\pm}5%RH$. However ideal sampling rates(DA/L) were 33 % higher than experimental sampling rates. 3. The initial response(15~16 min) of the testing monitor was 2 times higher than the actual concentration determined by the reference methods at $24{\pm}2^{\circ}C$, $8{\pm}5%RH$ and $80{\pm}5%RH$. Within 1 hours, the curve reached a linear horizontal line at low humidity condition. But sampling efficiencies decreased with respect to time at high humidity condition. And sampling efficiencies were higher at high humidity condition than low humidity condition for MIBK. 4. At very low velocity (less than 0.02 m/sec), the concentration of ACF diffusive monitor were poorly estimated. But ACF diffusive monitor were not affected at higher velocity(0.2 m/sec-0.6 m/sec). 5. There was no significant reverse diffusion when the ACF monitors were exposed to clean air for 2 hours after being exposed for 2 hours at the level of 1 TLV. 6. There was no significant sample loss during 3 weeks of storage at room temperature and 5 weeks of storage at refrigeration.

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Performance of Institute of Occupational Health, Korean Industrial Health Association in Proficiency Analytical Testing Program (대한산업보건협회 산업보건연구소의 PAT 정도관리 참여결과)

  • Lee, Jun-Seong;Yoo, Ho-Kyum;Oh, Mi-Soon;Park, Wha-Me;Yun, Gi-Sang;Choi, Ho-Chun;Chung, Kyou-Chull
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.6 no.2
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    • pp.313-321
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    • 1996
  • Our laboratoy has been participated in Proficiency Analytical Testing (PAT) program which is operated by the Americal Industrial Hygiene Association in cooperation with the National Institute for Occupational Safety and Health (NIOSH). The program is designed to assist a laboratory improve its analytical performance by providing samples on a quarterly basis, evaluating the results, and providing reports on how well the laboratory performed. Evaluation of the results reported here covers five rounds of the PAT program (round 121~round 125). The way a laboratory is evaluated by PAT program is as follows: 1) There is no overall proficiency rating given to a laboratory. 2) A proficiency rating is given for each type of analyze (i.e., metals, silica, asbestos, solvents) that a laboratory analyzed. 3) Proficiency is rated acceptable ("A") if Z score lies between -3 and +3, and unacceptable if Z score is either higher than +3 ("H") or lower than -3 ("Lo"). Z score = (reported data - reference value) / standard deviation 4) For a laboratory to be rated proficient it must either have had no outliers over the most recent two rounds or of the samples actually analyzed over the past year (past four rounds), 75 % or more of the analyze sample results must be acceptable. According to the above rating criteria of PAT program, performance of metals including cadmium, lead, chromium and zinc, and asbestos sample analyses were rated acceptable ("A"). For silica analyses, all samples except one out of four samples in round 122 was rated high("H") were acceptable showing 95 % of ing 95 % of acceptance rate (19/20) throughout the rounds. Analyses of organic solvents were done on 52 samples in 9 types including methanol(MOH), 1,1,1-trichloroethane(MCM), tetrachloroethylene(PCE), trichloroethylene(TCE), benzene(BNZ), o-xylene(OXY), toluene(TOL), chloroform(CFM), 1,2-dichloroethane(DCE). All samples analyzed were rated acceptable except 2 samples that were rated high; one out of each four MCM and TCE samples in round 121, and one that was low out of four o-xylene analyses in round 122 indicating 94 % of acceptance rate(49/52) throughout the rounds. According to the laboratory rating criteria, our laboratory is rated proficient so far for all types of contaminants.

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Total Deformity Angular Ratio as a Risk Factor for Complications after Posterior Vertebral Column Resection Surgery

  • Lee, Byoung Hun;Hyun, Seung-Jae;Han, Sanghyun;Jeon, Se-Il;Kim, Ki-Jeong;Jahng, Tae-Ahn;Kim, Hyun-Jib
    • Journal of Korean Neurosurgical Society
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    • v.61 no.6
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    • pp.723-730
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    • 2018
  • Objective : The aim of the present study was to identify whether the deformity angular ratio (DAR) influences the occurrence of complications after posterior vertebral column resection (PVCR) and to establish the DAR cut-off value. Methods : Thirty-six consecutive patients undergoing PVCR from December 2010 to October 2016 were reviewed. The relationships between the total, sagittal, and coronal DAR and complications were assessed using receiver operator characteristics curves. The patients were divided into two groups according to a reference value based on the cut-off value of DAR. Demographic, surgical, radiological, and clinical outcomes were compared between the groups. Results : There were no significant differences in the patient demographic and surgical data between the groups. The cut-off values for the total DAR (T-DAR) and the sagittal DAR (S-DAR) were 20.2 and 16.4, respectively (p=0.018 and 0.010). Both values were significantly associated with complications (p=0.016 and 0.005). In the higher T-DAR group, total complications (12 vs. 21, p=0.042) and late-onset complications (3 vs. 9, p=0.036) were significantly correlated with the T-DAR. The number of patients experiencing complications (9 vs. 11, p=0.029) and the total number of complications (13 vs. 20, p=0.015) were significantly correlated with the S-DAR. Worsening intraoperative neurophysiologic monitoring was more frequent in the higher T-DAR group (2 vs. 4) than in the higher S-DAR group (3 vs. 3). There was no difference in neurological deterioration between the groups after surgery. Conclusion : Both the T-DAR and the S-DAR are risk factors for complications after PVCR. Those who had a T-DAR >20.2 or S-DAR >16.4 experienced a higher rate of complications after PVCR.