• The Journal of KAIRB
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• v.5 no.1
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• pp.21-32
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• 2023

Purspose: The purpose of this study is to examine the meaning and definition of vulnerable subjects in clinical trials in light of domestic and international regulations and guidelines, to analyze the contents of standard operation procedures (SOPs) among advanced general hospitals in Korea that conduct clinical trials, and to examine deliberation procedures for operation plans. Methods: The study examined how vulnerable research subjects were defined and described in related regulations and the classification of vulnerable research subjects presented in the IRB/HRPP SOPs of 18 clinical trial institutions, including 11 AAHRPP-accreditated general hospitals in Korea, as well as the operation of the IRB deliberation. Results: Among all domestic and international regulations and guidelines, only the The Council for International Organization of Medical Sciences (CIOMS) guidelines explain why vulnerability is related to judgments on the severity of physical, psychological, and social harm, why individuals are vulnerable, and for what reasons. However, the classification of vulnerable subjects by institutions differed from the classification by the International Conference on Harmonization-Good Clinical Practice (ICH-GCP). A total of the 16 institutions classified children and minors as vulnerable research subjects. 14 institutions classified subjects who cannot consent freely were classified as vulnerable subjects. 15 institutions classified sujects who can be affected by the organizational hierarchy were classified as vulnerable subjects. Subjects in emergency situations were regarded as vulnerable research subjects in 8 of institutions, while people in wards, patients with incurable diseases, and the economically poor including the unemployed were categorized as vulnerable research subjects in 7, 4, and 4 of institutions, respectively. Additionally, some research subjects were not classified as vulnerable by ICH-GCP but were classified as vulnerable by domestic institutions 15 of the institutions classified pregnant women and fetuses as vulnerable, 11 classified the elderly as vulnerable, and 6 classified foreigners as vulnerable. Conclution: The regulations and institutional SOPs classify subjects differently, which may affect subject protection. There is a need to improve IRBs' classifications of vulnerable research subjects. It is also necessary to establish the standards according to the differences in deliberation processes. Further, it is recommended to maintain a consistent review of validity, assessment of risk/benefit, and a review using checklists and spokeperson. The review of IRB is to be carried out in a manner that respects human dignity by taking into account the physical, psychological, and social conditions of the subjects.

• Journal of the Society of Cosmetic Scientists of Korea
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• v.49 no.4
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• pp.291-298
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• 2023

In this study, a quantitative analysis method was developed using high-performance liquid chromatography (HPLC) to analyze the content of ceramide NP in lotion, cream, and cleanser formulations in cosmetics. The analysis was performed using a C18 column, and the mobile phase was set at a ratio of 70 : 30 for acetonitrile and methanol, the flow rate was set to 0.8 mL/min, and the column temperature was set to 20 ℃. The method was verified by analyzing specificity, linearity, limit of detection, limit of quantitation, accuracy, and precision in accordance with the ICH guidelines. As a result of validating the method, the linearity of the calibration curve was excellent (R² = 0.99984). The accuracy of the lotion, cream, and cleanser formulations was confirmed with a recovery rate ranging from 95.11% to 100.48%. The precision analysis showed a low relative standard deviation (RSD) of less than 0.26%. The limit of detection was 0.902 ㎍/mL, and the limit of quantitation was 2.733 ㎍/mL. Through this quantitative analysis method of ceramide NP applied in cosmetics, it is expected to assist in the quality control of products by enabling measurement even when it is difficult to separate the main peak due to the influence of interfering substances.

• Korean Journal of Radiology
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• v.25 no.2
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• pp.166-178
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• 2024

Objective: This study aimed to determine the predictive performance of non-contrast CT (NCCT) signs for hemorrhagic growth after intracerebral hemorrhage (ICH) when stratified by onset-to-imaging time (OIT). Materials and Methods: 1488 supratentorial ICH within 6 h of onset were consecutively recruited from six centers between January 2018 and August 2022. NCCT signs were classified according to density (hypodensities, swirl sign, black hole sign, blend sign, fluid level, and heterogeneous density) and shape (island sign, satellite sign, and irregular shape) features. Multivariable logistic regression was used to evaluate the association between NCCT signs and three types of hemorrhagic growth: hematoma expansion (HE), intraventricular hemorrhage growth (IVHG), and revised HE (RHE). The performance of the NCCT signs was evaluated using the positive predictive value (PPV) stratified by OIT. Results: Multivariable analysis showed that hypodensities were an independent predictor of HE (adjusted odds ratio [95% confidence interval] of 7.99 [4.87-13.40]), IVHG (3.64 [2.15-6.24]), and RHE (7.90 [4.93-12.90]). Similarly, OIT (for a 1-h increase) was an independent inverse predictor of HE (0.59 [0.52-0.66]), IVHG (0.72 [0.64-0.81]), and RHE (0.61 [0.54-0.67]). Blend and island signs were independently associated with HE and RHE (10.60 [7.36-15.30] and 10.10 [7.10-14.60], respectively, for the blend sign and 2.75 [1.64-4.67] and 2.62 [1.60-4.30], respectively, for the island sign). Hypodensities demonstrated low PPVs of 0.41 (110/269) or lower for IVHG when stratified by OIT. When OIT was ≤ 2 h, the PPVs of hypodensities, blend sign, and island sign for RHE were 0.80 (215/269), 0.90 (142/157), and 0.83 (103/124), respectively. Conclusion: Hypodensities, blend sign, and island sign were the best NCCT predictors of RHE when OIT was ≤ 2 h. NCCT signs may assist in earlier recognition of the risk of hemorrhagic growth and guide early intervention to prevent neurological deterioration resulting from hemorrhagic growth.

• Bulletin of the Korean Chemical Society
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• v.34 no.9
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• pp.2663-2670
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• 2013

The purpose of stability testing is to provide evidence about how the quality of a drug varies with time under the influence of a variety of environmental factors. In this study, erythropoietin (EPO) was analyzed under different pH (pH 3 and pH 9) and temperature ($25^{\circ}C$ and $40^{\circ}C$) conditions according to current Good Manufacturing Practice (cGMP) and International Conference on Harmonisation (ICH) guidelines. The molecular weight difference between intact EPO and deglycosylated EPO was determined by SDS-PAGE, and aggregated forms of EPO under thermal stress and high-pH conditions were investigated by size exclusion chromatography. High pH and high temperature induced increases in dimer and high molecular weight aggregate forms of EPO. UPLC-ESI-TOF-MS was applied to analyze the changed modification sites on EPO. Further, normal-phase high-performance liquid chromatography was performed to identify proposed glycan structures and high pH anion exchange chromatography was carried out to investigate any change in carbohydrate composition. The results demonstrated that there were no changes in modification sites or the glycan structure under severe conditions; however, the number of dimers and aggregates increased at $40^{\circ}C$ and pH 9, respectively.

• The Korean Journal of Health Service Management
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• v.11 no.1
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• pp.91-105
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• 2017

Objectives : This study analyzed the differences in length of stay(LoS), total hospital charges(THC), and cost of rehabilitation(CoR) between two types of stroke patients, intracerebral hemorrhage(ICH) and cerebral infarction(CI). Factors associated with these differences were also assessed. Methods : Data were obtained from the 2011 National Inpatient Sample data of Health Insurance Review and Assessment Service. We used propensity score matching to match the characteristics of the two types of stroke patients, and conducted a regression analysis to analyze their associations. Results : The differences between THC, LoS, and CoR by stroke and hospital types were shown. Each type of hospital showed different results. Conclusions : A rapidly aging population will accelerate the number of stroke patients requiring effective management. Studies evaluating healthcare utilization of stroke patients will provide evidence for both healthcare resources allocation and healthcare policy decisions.

• Koreanishche Zeitschrift fur Deutsche Sprachwissenschaft
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• v.6
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• pp.155-184
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• 2002

Die dritte Konstruktion zeichnet sich dadurch aus, dass Elemente, die vom zu-Infinitiv im 'Nachfeld' $abh\"{a}ngen$, links vom Matrixverb auftreten. Die dritte Konstruktion weist sowohl Eigenschaften auf, die sie als $inkoh\"{a}rent$ ausweist, als auch Eigenschaften, die als syntaktische Reflexe von $Koh\"{a}renzbildung$ bezeichnet werden $k\"{o}nnen$. Das $vollst\"{a}ndig$ extraponierte zu-Infinitivkomplement ist immer satzwertig $(inkoh\"{a}rent),\;w\"{a}hrend$ der intraponierte zu-Infinitiv sowohl nicht-satzwertig $(koh\"{a}rent)$, als auch satzwertig $(inkoh\"{a}rent)$ sein kann. In der vorliegenden Arbeit wird eine constraint-basierte Analyse zur Synatx der dritten Konstruktion im Deutschen dargestellt. Die Analyse wird im Rahmen der Head-driven Phrase Structure Grammar (HPSG) $durchgef\"{u}hrt$, bei der ich wooer von der Bewegung der Komplemente aus dem Nachfeld noch von der Linearen $Pr\"{a}zedenz$ mit neuen Merkmalen ausgehe, sondem von der Typenhierarchie der Konstruktionentypen mit relevanten $Lexikoneintr\"{a}gen$. Es wird zu zeigen versucht, dass die dritte Konstruktion ein Komplementationstyp von non-flip-phrase und partial-vp-extra­phrase ist.

• Koreanishche Zeitschrift fur Deutsche Sprachwissenschaft
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• v.9
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• pp.1-21
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• 2004

Die sogenannten verba pura bilden eine Teilmenge der germanischen starken Verben der VII. KLasse. Sie sind auf einsilbige langvokalisch auslautende Wurzeln des Vorurgermanischen $zur\"{u}ckzufuhren$: z. B. ${\ast}kn\bar{e}an$ 'erkennen', ${\ast}m\bar{e}an$ '$m\"{a}hen$', ${\ast}bl\bar{o}an$ $'bl\"{u}hen'$, ${\ast}m\bar{o}an$ $'qu\"{a}hlen'$. Um den Begriff der verba pura genau zu $erkl\"{a}ren$, stellt man diesen Verben die sogenannten verba impura $gegen\"{u}ber$, bei denen auf die lang Wurzelvokale urgerm. ${\ast}-\bar{e}-$ und ${\ast}-\ber{o}-$ ein Konsonant folgl: z.. B. urgerm. ${\ast}l\bar{e}tan$ (got. \etan) 'lassen', ${\ast}hw\bar{o}pan$ (got. hvopan) 'sich $r\"{u}hmen$'. Die germanischen starken Verben der VII. Klasse hat die $st\"{a}rksten$ Umgestaltungen mitgemacht, und zwar die verba pura noch mehr. In diesem Aufsatz untersuchte ich die $Gr\"{u}nde$ ihrer Umgestaltungen im germanischen Verbalsystem. Danach wird der Vorgang erschlossen, wie die verba pura in Ahd. zu den schwachen Verben I $\"{u}bertraten$. Dabei werden die folgenden Punkte besonders behandelt: Hatten die $fr\"{u}hzeitigen${\;}Pr\"{a}sensformen$ der verba pura -i-, das aus -jan herausgeht? Wenn nein, wie haben die verba pura zur schwachen Flexion $\"{u}bertraten$? Warum konnten die verba pura wie die anderen redupliziernden Verben in Ahd. nicht zu ablautenden Verben $\"{u}bergehen$?

• Environmental Mutagens and Carcinogens
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• v.21 no.1
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• pp.34-43
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• 2001

Di-2-ethylhexyl phthalate (DEHP) is the most commonly used phthalate ester in polyvinyl chloride formulations including food packing and storage of human blood. DEHP is a well known as non-genotoxic carcinogen and endocrine disrupting chemical (EDC). DEHP have shown all negative results in ICH-guildeline recommended standard genotoxicity test battery. In this study, to assess the clastogenic and DNA damaging effect in human-derived tissue specific cells, DEHP was treated in human derived MCE-7 cells, HepG2 cells, LNCap cells, BeWo cells, MCE-10A cells, and female peripheral blood cells using micronucleus assay and in human breast carcinoma MCF-7 cells up to $1.28$\times$10^{-2}$ M using Comet assay. The in vitro micronucleus assay is a mutagenicity test system for the detection of chemicals which induce the formation of small membrane bound DNA fragment i.e. micronuclei in the cytoplasm of interphase cells, originated from clastogenic and/or aneugenic mechanism. The single cell gel electrophoresis assay (Comet assay) is used to detect DNA strand-breaks and alkaline labile site. In our results, DEHP increased significantly and/or dose-depentently and time-dependently micronucleus frequency at the 6 and 24 hr without metabolic activation system only in MCE-7 cells. DEHP treated with 2 hrs in MCF-7 cells using Comet assay induced DNA damage dose-depentantly.

• Natural Product Sciences
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• v.12 no.1
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• pp.55-61
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• 2006

A description of simple, isocratic and precise reversed phase HPLC methods is given for simultaneous quantification of pholcodine and ephedrine hydrochloride together with either carbinoxamine maleate or terfenadine in antitussive-antihistaminic oral pharmaceutical formulations. Separations were carried out on X-Terra and symmetry shield C18 column $(250\;{\times}\;4.6\;mm,\;5\;{\mu}m)$. The used isocratic elution systems were either $0.02\;M\;KH_2PO_4-acetonitrile$ in the ratio of 75 : 25 and pH adjusted to 7.70 with orthophosphoric acid or sodium hydroxide, for syrup (method A), or 0.02 octanesulphonic acid sodium salt solution-acetonitrile-acetic acid in the ratio of 75 : 25 : 0.5 for suspension (method B). The elution of both mixtures was achieved with a flow rate of 1 ml/min. Detection was carried out by UV absorbance at wavelengths of 220 and 250 nm for syrup and suspension, respectively. The quantification of the components in synthetic mixtures and actual syrup and suspension were calculated using the internal standard technique with metoclopramide HCl and codeine phosphate as internal standards (IS), respectively. The methods, for both mixtures, were validated and met all the requirements for the quality control analysis recommended by FDA and ICH.

• Korean Journal of Pharmacognosy
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• v.41 no.1
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• pp.48-53
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• 2010

GCSB-5 preparation is a purified extract from a mixture of 6 medicinal plants(Acanthopanacis Cortex, Achyranthis Radix, Saposhnikoviae Radix, Cibotii Rhizoma, Glycine Semen Nigra, Eucommiae Cortex) that have been widely used for the treatment of various bone disorders. The aim of this study was to investigate HPLC analysis method and screening of standard compound on Cibotii Rhizoma for quality standardization of a medicinal crude drug GCSB-5. Onitin-4-O-$\beta$-D-glucopyranoside was isolated from Cibotii Rhizoma as the standard compound and identified on the basis of spectroscopic data such as NMR. HPLC analysis method for the determination of onitin-4-O-$\beta$-D-glucopyranoside was established for the quality control of the medicinal plants of Cibotii Rhizoma species, GCSB-5 raw material and GCSB-5 preparation. And validation of HPLC analysis methods were conformed for verification of HPLC methods by check to specificity, linearity, intra-day precision, inter-day precision and accuracy following ICH guideline.