Purpose : To propose various types of clinical research which is feasible for botanical new drug (IND) development processes, and suggest essential steps to development of study protocol for IND. Methods : Literature-based discussions and one research group's experience is given regarding domestic act, regulation, and system. Results : In order to get an approval of IND for botanical drug in Korea there are several types of clinical research to conduct. In quality control steps for standardized medicinal herbs, case reports or case series can be conducted, and for good manufacturing practice(GMP) steps, we can conduct case reports, case series, and retrospective cohort studies. In addition, as long as we gathered good laboratory practice(GLP) data we can conduct up to quasi-experimental studies and clinical trials including investigator initiated trials. In order to conduct these studies development of study protocol is essential. First, we obtain historical evidence including target disease and indication, efficacy, safety, and endpoints by reviewing medical classics. Second, we obtain clinically and statistically important data by conducting non-clinical studies, observation studies, and quasi-experimental studies. Third, we generate research hypotheses and purposes and explore methodologies, endpoints, clinical practice guidelines, cost-effectiveness, and commercial potential. Finally, we develop study protocol with aid of biostatistician or expert in contract research organization. Discussions and conclusions : This study have obvious limitations in that most thoughts, suggestions, and proposes are from one research group's experience. Therefore, we hope to see various types of research in this topic and process from other research group as well.
Park Moon-Kyung;Cho Sun-Kyung;Cha Jin-A;Yang Il-Sun
Journal of Nutrition and Health
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v.39
no.4
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pp.417-425
/
2006
The purpose of this study were to a) investigate operation of human resource in contract foodservice management company (CFMC), b) identify the staffing indices for the establishment an labor productivity for CFMC, and c) develop standardized model of staffing demand as foodservice's scale in CFMC. The data was collected using FS intra-net system from 138 contract-managed foodservice operations in A CFMC and statistical analysis was completed using the SAS/win package (ver. 8.0) for description analysis, ANOVA, Duncan multiple comparison, pearson correlation analysis, and regression analysis. The types of operation were included factory (45%), small scale operation (26%), office (11%), department store (10%), training institute (4%), and hospital (3%). The distribution of foodservice scale was classified by meal served was as follows; 'less than 500 meals (47%)', 'from 500 to 1500 meals (25%)', 'from 1500 to 2500 meals (17%)', and 'more than 2500 meals (12%)'. There was two types of contract method, fee-contract (53%) and profit-and-loss contract (46%) Some variables were significantly high operation indices such as selling price, food cost, monthly sales, net profit and others were significantly low operation indices such as labor, meal time a day in the small foodservice on meal scale (p<.001). The more foodservice was large, the more human resource was disposed on dietitian, cook, cooking employee altogether (p<.001). Foodservice in A CFMC was divided into 2 groups by 500 meals a day, according to comparative analysis of labor productivity as meal scale per working hour, meal scale a day and operation indices as meal per foodservice employee, meal per cooking employee (p<.001). The regression equation model was developed as 'the number of employees=1.82+0.014 ${\times}$ meal served' in the operation of less than 500 meals, 'the number of employees=9.42+0.013 ${\times}$ meal scale a day -0.94 ${\times}$ meal scale per working hour' in the operation over 500 meal scale using labor productivity indices and operation indices. Therefore, CFMC could be enhanced efficiency of human resource arrangement using the standardized model of staffing demand and would be increased effectiveness of profit.
Among numerous policy influencers' and researchers' advices and policy suggestions, there is little opposition to the proposition that technology is essential to the economic development. The role of technology has never been more emphasized than today in Korea as in any other countries. The effects of the government's innovation policy on corporate R&D activities and more broadly the economic welfare of a whole nation are widely recognized with intuitional and empirical evidence. That is, various R&D incentives reduce the marginal cost of a firm's R&D efforts, inducing as much increase of its R&D investment to result in a better chance to acquire target technology. This paper examines the impact of R&D incentives on the technological outcomes by analyzing individual firms' investment behaviors subject to the government's R&D incentive policies. An econometric model of technological outcomes is estimated on a project level with cross-sectional data. "Probit model" is employed for estimations. Special attention was given to the effectiveness of R&D programs by estimating policy impact by types of investment. The data were collected from 928 different R&D projects completed between 1987 and 1993. With the single equation approach, we were able to find that the structure of investment is a far more significant factor in technological outcomes than the total amount of investment. The analysis also shows that the two types of firms' matching investment, in-kind and cash, do not bear a complementary, but a substitutive relations to each other. It also reconfirms the proposition that R&D incentives increase firm's financial investment. Despite many supportive studies emphasizing the cooperation between innovation performers, it is also found that the larger the number of institutions involved in a project, the less likely it leads to a technological success, And meeting the proposed deadlines without postponing is estimated to be a good barometer to predict the outcome of an R&D project. Also the probabilities of success for major variables are represented for policy implications, after calculating marginal effects.
Proceedings of the Korea Society for Simulation Conference
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2001.10a
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pp.170-202
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2001
Simulation is used to reduce a risk involved in the new project and decision-making in an organization and to save cost and time by forecasting different situations. The objectives of this research are to acknowledge the need of simulation through the real life sample and to encourage the use of the simulation method in the future consulting project by continuously making the necessary improvements. This research analyzed the effectiveness of the simulation based on the sample use of simulation method in 1994 and 1997 for the BPR project of certification issuance process at the Supreme Court. In order to evaluate the value of the proposed simulation model, we examined the gap, which existed between the simulation result and the operational data collected by visiting the actual sites where AROS (Automated Registry Office System: automation system developed by LG-EDS Systems) is being utilized. We also identified the causes for the existing gap. According to the analysis result, (1) the gap came from the status change of thinking that the concentration of certification issuance request has eased after the computerization, (2) the gap existed in the operational process because they failed to consider the situational factors of each registry office in the simulation model, and (3) lastly the gap came from the difficulty of formulating the mathematical model for predicting the complex and diverse behavior pattern of individuals requesting the certification issuance. In order to narrow the existing gaps, we made a proposal to improve the certification issuance process where software of certification issuance vending machine was upgraded in order to help the people to use the service conveniently, more part time workers were hared when there was a overload of certification issuance request, and the quality of the certification Issuance vending machine is improved, In this research, we examined an efficient way of resource allocation based on the simulation conducted in 1994 and 1997. By reflecting changes since the simulation of 1994 and allocating the clerk and machine based on the predicted results of the simulation, we maximized the efficiency of the certification issuance process. In conclusion, this research examined the future usability of simulation method based on the analysis result and identified the key issues to consider when using the simulation method in the future consulting project.
The Journal of The Korea Institute of Intelligent Transport Systems
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v.17
no.4
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pp.86-98
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2018
Since 2015, the Korea Expressway Corporation has provided predicted travel time information, which is reproduced from DSRC systems over the extended expressway network in Korea. When it is open for public information, it helps travelers decide optimal routes while minimizing traffic congestions and travel cost. Although, sutiable evaluations to investigate the reliability of travel time forecast information have not been conducted so far. First of all, this study seeks to find out a measure of effectiveness to evaluate the reliability of travel time forecast via various literatures. Secondly, using the performance measurement, this study evaluates concurrent travel time forecast information in highway quantitatively and examines the forecast error by exploratory data analysis. It appears that most of highway lines provided reliable forecast information. However, we found significant over/under-forecast on a few links within several long lines and it turns out that such minor errors reduce overall reliability in travel time forecast of the corresponding highway lines. This study would help to build a priority for quality control of the travel time forecast information system, and highlight the importance of performing periodic and sustainable management for travel time forecast information.
This study is focused that the electronic commerce(EC) on the purchasing section may improve the efficiency and transparency of the hospitals management. After reviewing the purchasing activity of hospitals, I study the introduction, expected effects, and problems of EC. So, I am going to provide basic information for activating EC. The samples are managers of 170 hospitals, which are located on Seoul. As a result of collection this survey, I analyze 79 hospitals. For data analysis, I use $X^2$-test and ANOVA for purchasing management and the relevance of EC according to the level of care. The results of this study are 1. The problems on the management of purchasing section are: firstly, they don't have sufficient time to study market. Secondly, it is difficult to find competitive suppliers. And, lastly, they cannot gather a lot of information about the price of products. 2. There are many answers of the needs on the introduction of B2B. However, some hospitals think they don't need it. But, the most answers are that the EC will be settled within 4 years. So, we can realize that these hospitals are getting interested on the EC. On the other hand, I find that they prefer outside EC companies for the introduction of EC. 3. On the expected effects on EC, first is the effectiveness of the market survey. The next is to collect information of adequate price of products owing to clear transaction, find easier new suppliers and gather useful data. 4. On the external problems of the introduction of EC, there is low credibility related to the security and the weakness of suppliers' information system. Especially, on the Real Transaction Price Payment system, the bigger bed size, the higher understanding on these problems. On the internal problems of the introduction of EC, first is the burden of the introduction of EC and operating cost. Especially, on the burden of the disclosure of revenue source, the smaller bed size, the higher understanding on this problem So, this is a point which deserves my attention statistically. However, this shows relatively little understanding about incomplete the standard of product category and the weak information system of hospital. Through this study, I am going to suggest 3 points for the activation of the introduction of EC on hospitals. 1. The reform of the Real Transaction Price Payment System on medical supplies and materials for medical treatment 2. The establishment of the standard of product category 3. The promotion of information system based on network.
Purpose: The purpose of this study was to provide a critical assessment of evidence-based Korean pediatric research that can inform clinical practicability of, and future research on distraction interventions for pediatric procedural pain management. Methods: A critical review of evidence-based Korean pediatric research was conducted. Databases were searched to identify research that included an evaluation of a distraction intervention as an intervention for pediatric procedural pain management. The search yielded 68 studies. Results: From these studies, 14 were included for this review and all were recently published (2003-2014). Quasi experimental designs were most frequently used (n=12) and for 71.4% the focus was preschoolers. Audiovisual techniques were the most common form of distraction. In most studies clinical utility of the distraction intervention was not examined. Fairly consistent reductions in behavioral measures of pain in association with the distraction intervention were found but less consistent results were found for physiological measures. Conclusion: Lack of methodological rigor limits the evidence for distraction interventions to reduce pain and fear experienced by children during painful procedures. Further research to analyze the cost and time-effectiveness and to identify consumer and provider satisfaction with distraction interventions is needed to determine whether distraction interventions are clinically relevant.
Journal of the Korean Institute of Intelligent Systems
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v.13
no.2
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pp.247-258
/
2003
In this paper, we present a pen-shaped input device equipped with accelerometers and gyroscopes that measure inertial movements when a user writes on 2 or 3 dimensional space with the pen. The measurements from gyroscope are integrated once to find the attitude of the system and are used to compensate gravitational effect in the accelerations. Further, the compensated accelerations are integrated twice to yield the position of the system, whose basic concept stems from the field of inertial navigation. However, the accuracy of the position measurement significantly deteriorates with time due to the integrations involved in recovering the handwriting trajectory This problem is common in the inertial navigation system and is usually solved by the periodic or aperiodic calibration of the system with external reference sources or other information in the filed of inertial navigation. In the presented paper, the calibration of the position or velocity is performed on-line and off-line. In the on-line calibration stage, the complementary filter technique is used, where a Kalman filter plays an important role. In the off-line calibration stage, the constant component of the resultant navigational error of the system is removed using the velocity information and motion detection algorithm. The effectiveness and feasibility of the presented system is shown through the experimental results.
Simulated Moving Bed(SMB) process consists of multiple chromatographic columns, which are usually partitioned into four zones. Such a process characteristic allows a continuous binary separations those are impracticable in conventional batch chromatographic processes. Compared with batch chromatography, SMB has advantages of continuity, high purity and productivity. Various researches have been reported for the integration of reaction and recovery during process operation on the purpose of economics and effectiveness. Simulated Moving Bed Reactor(SMBR) is introduced to combine SMB as a continuous separation process and reactor. Several cases of SMBR have been reported for diverse reactions with catalytic, enzymatic and chemical reaction on ion exchange resin as main streams. With an early type of fixed bed using catalyst, SMBR has been developed as SMB using fluidized enzyme, SMB with immobilized enzyme and SMB with discrete reaction region. For simple modeling and optimization of SMBR, a method considering convection only is possible. A complex method considering axial dispersion and mass transfer resistance is needed to explain the real behavior of solutes in SMBR. By combining reaction and separation, SMBR has benefits of lower installation cost by minimizing equipment use, higher purity and yield by avoiding the equilibrium restriction in case of reversible reaction.
We propose a method to compose a foreground object into a background image, where the foreground object is a part (or a region) of an image taken by a front-facing camera and the background image is a whole image taken by a back-facing camera in a smart phone at the same time. Recent high-end cell-phones have two cameras and provide users with preview video before taking photos. We extract the foreground object that is moving along with the front-facing camera using the optical flow during the preview. We compose the extracted foreground object into a background image using a simple image composition technique. For better-looking result in the composed image, we apply a border smoothing technique using a weighted-border mask to blend transparency from background to foreground. Since constructing and grouping pixel-level dense optical flow are quite slow even in high-end cell-phones, we compute a mask to extract the foreground object in low-resolution image, which reduces the computational cost greatly. Experimental result shows the effectiveness of our extraction and composition techniques, with much less computational time in extracting the foreground object and better composition quality compared with Poisson image editing technique which is widely used in image composition. The proposed method can improve limitedly the color bleeding artifacts observed in Poisson image editing using weighted-border blending.
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