• Title/Summary/Keyword: Evaluation Guidelines

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Bioequivalence Evaluation of Pylocin Tablet to Klaricid Tablet (Clarithyomycin, 250 mg) (클래리시드 정(클래리스로마이신 250 mg)에 대한 파이로신 정의 생물학적 동등성)

  • Cho, Hea Young;Kim, Soo Jin;Sim, Young Sun;Lim, Dong Koo;Oh, In Joon;Lee, Yong Bok;Moon, Jai Dong
    • Korean Journal of Clinical Pharmacy
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    • v.10 no.1
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    • pp.13-18
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    • 2000
  • The bioequivalence of two clarithromycin tablets, the $Klaricid^{TM}$ (Ciba-Geigy Korea Ltd.) and the $Pylocin^{TM}$ (Kyungdong Pharmaceutical Co., Ltd.), was evaluated according to the Korean Guidelines for Bioequivalence Test (KGBT 1998). Sixteen healthy male volunteers ($20\sim26$ years old) were randomly divided into two groups and a randomized $2\times2$ cross-over study was employed. After one tablet containing 250 mg of clarithromycin was orally administered, blood sample was taken at predetermined time intervals, and the concentrations of clarithromycin in serum were determined using high-performance liquid chromatographic method with electrochemical detector. The pharmaco-kinetic parameters (area under the concentration-time curve: $AUC_t$, maximum concentration; $C_{max}$ and time to maximum concentration; $T_{max}$) were calculated and analysis of variance (ANOVA) was utilized for the statistical analysis of parameters. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two tablets based on $Klaricid^{TM}$ tablet were $-0.22\%,\;-0.48\%\;and\;-1.63\%$, respectively. The powers $(1-\beta)\;for\;AUC_t,\;C_{max}\;and\;T_{max}\;were\;99.07\%,\;88.15\%\;and\;99.99\%$, respectively. Detectable differences $(\Delta)\;and\;90\%$ confidence intervals ($\alpha$=0.10) were all less than $\pm20\%$ All the parameters above met the criteria of KGBT 1998, indicating that $Pylocin^{TM}$ tablet is bioequivalent to $Klaricid^{TM}$ tablet.

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A Study on Universal Design Using PSD (Preference Set-Based Design) Method (PSD법을 이용한 유니버설 디자인에 관한 연구)

  • Nahm, Yoon-Eui;Ishikawa, Haruo
    • Journal of Korean Society of Industrial and Systems Engineering
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    • v.38 no.3
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    • pp.127-135
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    • 2015
  • Universal design is defined as the design process of products and environments usable by all people to the greatest extent possible, without the need for adaptation or specialized design. The benefits of universal design have been promoted primarily through illustrative 'success stories' of public, residential and occupational environments and products. While case examples may be informative, they may unfortunately be limited in terms of generality to other designs or tasks. Therefore, design methods and criteria that can be applied systematically in a range of situations to encourage universal design are needed. In addition, the seven principles of universal design are intended to guide the design process. The principles provide a framework that allows a systematic evaluation of new or existing designs and assists in educating both designers and consumers about the characteristics of more usable products and environments. However, exactly how these principles are incorporated into the design process has beenleft up to the designer. Since the introduction of universal design, designers have become familiar with the principles of universal design, and they have developed many products based on universal design. However, the principles of universal design are qualitative, which means designers cannot quantitatively evaluate their designs. Some have worked to develop more systematic ways to evaluate products and environments by providing design guidelines for each of the principles. However, recommendations have not yet been made regarding how to integrate performance measures of universal design into the product design process before the product is mass produced. Furthermore, there are sets of requirements regarding each user group that has different age and ability. Consequently, there is an urgent need for design methods, based on a better understanding of age and ability related factors, which will lead to a universally designed product or environment. The authors have proposed the PSD (Preference Set-Based Design) method that can generate a ranged set of feasible solutions (i.e., robust and flexible solution set) instead of single point solution that satisfies changing sets of design targets. The objective of this paper is to develop a general method for systematically supporting the universal design process. This paper proposes the applicability of PSD method to universal design. Here, the proposed method is successfully illustrated with a universal design problem.

Incentive Design Considerations for Free-riding Prevention in Cooperative Distributed Systems (협조적 분산시스템 환경에서 무임승차 방지를 위한 인센티브 디자인 고려사항 도출에 관한 연구)

  • Shin, Kyu-Yong;Yoo, Jin-Cheol;Lee, Jong-Deog;Park, Byoung-Chul
    • Journal of the Korea Society of Computer and Information
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    • v.16 no.7
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    • pp.137-148
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    • 2011
  • Different from the traditional client-server model, it is possible for participants in a cooperative distributed system to get quality services regardless of the number of participants in the system since they voluntarily pool or share their resources in order to achieve their common goal. However, some selfish participants try to avoid providing their resources while still enjoying the benefits offered by the system, which is termed free-riding. The results of free-riding in cooperative distributed systems lead to system collapse because the system capacity (per participant) decreases as the number of free-riders increases, widely known as the tragedy of commons. As a consequence, designing an efficient incentive mechanism to prevent free-riding is mandatory for a successful cooperative distributed system. Because of the importance of incentive mechanisms in cooperative distributed system, a myriad of incentives mechanisms have been proposed without a standard for performance evaluation. This paper draws general incentive design considerations which can be used as performance metrics through an extensive survey on this literature, providing future researchers with guidelines for the effective incentive design in cooperative distributed systems.

Drug Use Evaluation of Antihypertensive Agents by JNC VI Guidelines (고혈압 치료 지침 Vl에 의한 항고혈압제의 사용평가)

  • Kim, Kyung Hwa;Lee, Suk Hyang
    • Korean Journal of Clinical Pharmacy
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    • v.12 no.1
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    • pp.29-38
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    • 2002
  • Hypertension is an important public health problem because it increases the risk of stroke, angina, myocardial infarction, heart failure, and end-stage renal disease. If it is not actively treated, morbidity and mortality increase with hypertension-induced complications and quality of life decreases. This study was to evaluate the use of antihypertensive drugs and blood pressure changes and to compare algorithms chosen (or the 1st and 2nd line therapy of hypertension based on the JNC VI recommendations. The medical charts of 222 patients with essential hypertension at St. Vincent's Hospital in Suwon from January 1997 to January 2000 were reviewed retrospectively. Data collection and analysis included baseline BP underlying diseases and complications, administered antihypertensives, BP changes, changes of antihypertensive regimen, and adverse effects with treatments. As results, the higher BP the patients had, the more frequent they had target organ damages and clinical cardiovascular diseases. Mean duration to reduce blood pressure less than 140/90 mmHg was 8 weeks in $85.3\%$ of the patients. The rate of control in BP was $82.4\%$ at 6 months. The major antihypertensive drugs prescribed were calcium channel blockers $(61.8\%)$ , ACE inhibitors $(19.1\%),\;\beta-blockers\;(13.7\%)$ and diuretics $(5.3\%)$ as the 1st-line monotherapy. The methods of treatment used as the 1st-line therapy were monotherapy$(59\%)$ and combination therapy $(41\%)$. Blood pressure change was significantly greater for combination therapy than monotherapy$(-26.2\pm21.4\;vs.\;-18.56\pm16.7$ mmHg for systolic blood pressure; P<0.003, $-16.9\pm13.2\;vs.\;-9.2\pm12.8$ mmHg for diastolic blood pressure; p<0.001). When blood pressure was not completely controlled with the first antihypertensive selected, the 2nd line therapy had 4 options: addition of 2nd agent from different class; $66.2\%$, substitution with another drug, $21.9\%$ increase dose $11.9\%$ continue first regimen $27.9\%$ Calcium channel blockers were the most frequently prescribed agents. This was not comparable to the JNC VI guideline which recommended diuretics and $\beta-blockers$ for the 1st-line therapy. Most of patients achieved the goal BP and maintained it until 6 months, but the remaining patients should be controlled more tightly to improve their BP with combination of life style modification, patient education, and pharmacotherapy.

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Bioequivalence of Atorva Tablet® to Lipitor Tablet® (Atorvastatin 20 mg) (리피토정® (아토르바스타틴 20 mg)에 대한 아토르바정®의 생물학적동등성)

  • Lim, Hyun-Kyun;Lee, Tae-Ho;Lee, Jae-Hyun;Youm, Jeong-Rok;Song, Jin-Ho;Han, Sang-Beom
    • Journal of Pharmaceutical Investigation
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    • v.38 no.2
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    • pp.135-142
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    • 2008
  • The present study describes the evaluation of the bioequivalence of two atorvastatin tablets, Lipitor $Tablet^{(R)}$ (Pfizer, reference drug) and Atorva $Tablet^{(R)}$ (Yuhan, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Forty-nine healthy male Korean volunteers received each medicine at the atorvastatin dose of 40 mg in a $2{\times}2$ crossover study with a two weeks washout interval. After drug administration, serial blood samples were collected at a specific time interval from 0-48 hours. The plasma atorvastatin concentrations were monitored by an high performance liquid chromatography -tandem mass spectrometer (LC-MS/MS) employing electrospray ionization technique and operating in multiple reaction monitoring (MRM) and positive ion mode. The total chromatographic run time was 4.5 min and calibration curves were linear over the concentration range of 0.1-100 ng/mL for atorvastatin. The method was validated for selectivity, sensitivity, linearity, accuracy and precision. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 48hr) was calculated by the linear log trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were complied trom the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for Atorva $Tablet^{(R)}$ / Lipitor $Tablet^{(R)}$ were ${\log}\;0.9413{\sim}{\log}\;1.0179$ and ${\log}\;0.831{\sim}{\log}\;1.0569$, respectively. These values were within the acceptable bioequivalence intervals of ${\log}\;0.8{\sim}{\log}\;1.25$. Based on these statistical considerations, it was concluded that the test drug, Atorva $Tablet^{(R)}$ was bioequivalent to the reference drug, Lipitor $Tablet^{(R)}$.

A Comparative Study of Emotional Response to Korean Drama among Countries: With Drama 'Goblin' (한국 드라마 수용에 있어서 국가별 감정 반응 분석: 드라마 <도깨비>를 중심으로)

  • Lee, Yewon;Woo, Sungju
    • Science of Emotion and Sensibility
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    • v.20 no.4
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    • pp.31-40
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    • 2017
  • This research aims to investigate 'Hallyu' contents consumption tendency of consumers from Korea, Japan, and the United States by analyzing their emotional responses. With the development of social media, research on emotion analysis by reviewing text materials has grown. Whereas environmental variables affect consumer demand towards 'Hallyu' contents, little comparative analyses have been conducted on the emotional responses of consumers from different countries. In this research, the emotional prototype model proposed by Russell(1980) used to extract and distinguish emotional words to clarify how people in the three countries differently perceive the Korean drama "Goblin". First of all, the SNS reviews were collected during a two-month period (February 12 to April 12). Second, significant factors were identified in the collected data according to Russell's emotion model. Third, random forest was applied to organize the selected variables in the order of variable importance. Fourth, the correlations among the emotional words were compared. Lastly, the accuracy of the trained model was measured using the test dataset. The results show that "Happy" was found to be the greatest factor in Korea and in the United States and "Pleased" in Japan. Emotional words correlations showed that when watching the drama "Goblin", "passive unpleasure" was the main factor associated with individual's interest in Korea whereas "passive pleasure" was associated with individual's interest in Japan and in the United States. Based on the results, this research suggests the possibility of developing evaluation guidelines for emotional responses of different countries towards 'Hallyu' contents.

Impact of eating behavior on dietary habits and subjective oral health evaluation (음식섭취행동이 식습관 및 구강건강의 주관적 평가에 미치는 영향)

  • Lim, Kun-Ok;Woo, Seung-Hee;Kwak, Jung-Suk
    • Journal of Korean society of Dental Hygiene
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    • v.11 no.4
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    • pp.441-451
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    • 2011
  • Objectives : The purpose of this study was to examine the eating behavior of patients in a bid to facilitate the improvement of their eating behavior, as eating behavior seemed to affect oral health and dietary habits. Methods : The subjects in this study were 235 patients who visited the dental hygiene practice lab at C college in South Jeonla Province. After a survey was conducted, the collected data were analyzed with the statistical package SPSS 12.0. Results : 1. When their self-awareness of dietary habits and oral health was checked in consideration of eating behavior, those who thought they had very good dietary habits and were in good oral health had meals three times a day. Their eating time was very irregular, and they took 15 to 20 minutes to eat. Their overeating frequency was three or four times a week, and their frequency of eating between meals was once or twice a week. 2. On the contrary, the daily eating frequency of the patients who found themselves to have very bad dietary habits and to be in bad oral health was not fixed, and their eating time was neither regular nor irregular. They spent less than 10 minutes having a meal, and their overeating frequency was once or twice a week. Their frequency of having a snack was three or four times a week, and as for food preference, they had a liking for meat. 3. The patients considered themselves to be in better health when they had balanced meals and good eating behavior, namely good dietary habits. And they rated their own dietary habits higher when they were in a good oral state, had no experiences to feel pain in the mouth and didn't receive any dental treatment, namely when they were in good oral health. Conclusions : This study attempted to investigate the influence of eating behavior on oral health awareness. Another limitation of this study is that the geographic scope was just confined to an urban community in South Jeonla Province without checking any possible regional gaps. However, it's quite evident that eating behavior exerts an influence on oral health awareness, and it seems worth doing to examine a larger number of subjects by utilizing objective oral health guidelines.

At slaughtering and post mortem characteristics on Traditional market ewes and Halal market ewes in Tuscany

  • Sargentini, Clara;Tocci, Roberto;Campostrini, Matteo;Pippi, Eleonora;Iaconisi, Valeria
    • Journal of Animal Science and Technology
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    • v.58 no.9
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    • pp.35.1-35.10
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    • 2016
  • Background: The aim of this work was the comparison between the carcass and the meat ewes of the regional Traditional market and the Islamic religious (Halal) market. Methods: Thirty and 20 at the end of career traditional market and Halal market ewes were slaughtered following the EC (European Council, 2009) animal welfare guidelines. Live weight of ewes was taken and dressing percentage of carcasses was calculated. On every carcass zoometric measurement and the evaluation trough the EU grid rules were performed. On the Musculus longissimus thoracis of 12 Traditional market carcasses and 11 Halal market carcasses the physical-chemical and nutritional analysis were performed. Consumer tests for liking meat ewe were performed in order to find consumer's preference level for Traditional and Halal markets ewe meat. Considering as fixed factor the ewe meat market (Traditional and Halal), results were submitted to oneway Analysis of Variance (ANOVA) and to Principal Component Analysis (PCA). Results: The Halal market ewes have shown lower dressing percentages ($42.91{\pm}0.82$ vs $46.42{\pm}0.69$) and lower conformation score ($4.5{\pm}0.5$ vs $7.8{\pm}0.4$). The Halal market meat showed higher cooking loss in oven ($37.83{\pm}1.20$ vs $32.03{\pm}1.15%$), lesser Chroma value ($18.63{\pm}0.70$ vs $21.84{\pm}0.67$), and lesser Hue angle value ($0.26{\pm}0.02$ vs $0.34{\pm}0.02$). This product had also lower fat percentage ($4.2{\pm}0.4$ vs $7.09{\pm}0.4$). The traditional market meat had higher percentage in monounsatured fatty acids (MUFA) ($43.84{\pm}1.05$ vs $38.22{\pm}1.10$), while the Halal market meat had higher percentage in ${\omega}3$ poliunsatured fatty acids (PUFA) ($5.04{\pm}0.42$ vs $3.60{\pm}0.40$). The consumer test showed as the ewe meat was appreciate by the consumers. Conclusions: Both meat typologies have shown good nutritional characteristics. The traditional market meat had higher MUFA composition, and a better MUFA/satured fatty acids (SFA) ratio, while the Halal market meat had higher PUFA composition. These results were also supported by the PCA. The consumers preferred the traditional market meat.

Perceptions of Hospital Health Information Managers Regarding Present on Admission Indicators in Korea: A Qualitative Study (입원 시 상병의 수집 및 활용에 관한 보건의료정보관리사의 관점: 질적 연구)

  • Pyo, Jee-Hee;Choi, Eun-Young;Oh, Hae-Mi;Lee, Won;Kim, Ju-Young;Ock, Min-Su;Kim, So-Yoon;Lee, Sang-Il
    • Quality Improvement in Health Care
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    • v.26 no.1
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    • pp.23-34
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    • 2020
  • Purpose: This qualitative study was conducted to examine the current status and problems concerning the collection of present on admission (POA) indicators and determine how to use these indicators for evaluating the quality of care and degree of patient safety. Methods: A total of 11 health information managers were divided into two groups according to the size of their hospitals. Two focus group discussions (FGDs) were conducted, one for each group, which followed a pre-developed semi-structured guideline. The verbatim transcriptions of the FGDs were analyzed. Results: The majority of participants were concerned about entering POA flags honestly because they did not know how future POA indicators would be used. In particular, for some participants, POA N was a burden that could imply a signal of mismanagement within the medical institution. In addition, the lack of awareness and indifference of physicians regarding POA indicators were some of the difficulties for POA flag entry. Although medical institutions are making efforts to improve the accuracy of POA flagging, many participants mentioned the need to develop real case-oriented POA entry guidelines to improve the accuracy of POA flagging. Conclusion: To increase the validity of POA indicators, it is necessary to increase the level of awareness of POA indicators in physicians and other medical professionals. Furthermore, efforts related to POA indicators by individual medical institutions need to be reflected in the process evaluation.

Development of Operating Speed Prediction Models Reflecting Alignment Characteristics of the Upstream Road Sections at Four-Lane Rural Uninterrupted Flow Facility (상류부 선형특성을 반영한 지방부 왕복 4차로 연속류 도로의 주행속도 예측모형 개발)

  • Jo, Won-Beom;Kim, Yong-Seok;Choe, Jae-Seong;Kim, Sang-Yeop;Kim, Jin-Guk
    • Journal of Korean Society of Transportation
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    • v.28 no.5
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    • pp.141-153
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    • 2010
  • The study is about the development of operating speed prediction models aimed for an evaluation of design consistency of four lane rural roads. The main differences of this study relative to previous research are the method of data collection and classification of road alignments. The previous studies collected speed data at several points in the horizontal curve and approaching tangent. This method of collection is based on the assumption that acceleration and deceleration only occurs at horizontal tangents and the speed is kept constant at horizontal curves. However, this assumption leads to an unreliable speed estimation, so drivers' behavior is not well represented. Contrary to the previous approach, speed data were collected with one and data analysis using a speed profile is made for data selection before building final models. A total of six speed prediction models were made according to the combination of horizontal and vertical alignments. The study predicts that the speed data analysis and selection for model building employed in this study can improve the prediction accuracy of models and be useful to analyze drivers' speed behavior in a more detailed way. Furthermore, it is expected that the operating speed prediction models can help complement the current design-speed-based guidelines, so more benefits to drivers as real road users, rather than engineers or decision makers, can be achieved.