• Journal of Biomedical Engineering Research
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• v.40 no.6
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• pp.250-259
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• 2019

Ophthalmic Laser System is widely used in Selective Laser Trabeculoplasty of Open Angle Glaucoma and Ocular Hypertension. Versatile ophthalmic laser system is a medical device with technology that checks the condition of the treatment area by irradiating a continuous laser pulse on the treatment area, and monitoring the microbubble reaction caused by the temperature increase of the melanosome through the ultrasonic signal and the optical signal sensor. It performs selective laser treatment without damaging the photoreceptor by controlling the wavelength of the laser when microbubbles are detected. This study aims to suggest a guideline for evaluating safety, performance and clinical effectiveness of Versatile Ophthalmic Laser System in accordance with the growing technology. International Standards, Regulations, and Clinical Trial Protocols were investigated and analyzed for this study. As a result of this study, the safety, performance and clinical effectiveness test guideline for Versatile Ophthalmic Laser System were proposed. This guideline will ensure the safety and efficacy of Medical device, and furthermore it is expected to be able to promote the development of technology development by supporting a clinical trial plan.

• Journal of the Korean Society of Marine Environment & Safety
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• v.28 no.6
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• pp.973-991
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• 2022

Globally, several countries with sea are using eco-friendly energy resources through offshore wind power development by overcoming the weak point of the existing power generation method. The sea has the advantage of being able to develop large scale wind farms in wide waters, but the installation of marine structures threatens the safe operation of vessels. Accordingly, a standard guideline for safe navigation by analyzing the mutual effects between ship routes and offshore wind site was presented by the PIANC. Nonetheless, the standard guideline calculated the same safe distance in all situations. Therefore, this study developed a calculation model for an optimal safe distance between ship routes and offshore wind sites by reflecting the ship's maneuvering, encounter situations, environmental force, traffic density, offshore wind power generators, and channel types. As a result of the validation simulation, the developed model showed that the optimal safe distance was secured.

• YAKHAK HOEJI
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• v.55 no.4
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• pp.345-351
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• 2011

Gastritis is the most common disease among Korean. The demand for the development of gastritis drugs has been increasing. Currently, however, there is no guideline available for the clinical evaluation of gastritis drugs worldwide. As a consequence, domestic and international pharmaceutical companies make errors in the drug development processes, and it becomes difficult for them to establish the scientific validity and objectivity of newly developed drugs. The objective of this study was to develop the Guideline for Clinical Trials Evaluation of Gastritis which can be used in improving the quality and consistency of clinical trials. First, we collected and reviewed the clinical trials on gastritis drugs that were available from Japan Pharmaceuticals and Medical Devices Agency and Korea Food and Drug Administration (KFDA), and investigated the recent research trends on clinical trials of gastritis drugs. Reviewers from KFDA and National Institute of Food and Drug Safety Evaluation and scientific experts from the pharmaceutical industries developed the guidelines through regularly scheduled meetings. Opinions and consultation from academic fields and industry experts were also obtained. This project will provide the clinical trial practitioners, investigator and reviewers the scientific and rational guidelines for performance and evaluation of clinical trials for gastritis drugs. Furthermore, we hope this guideline contributes to establishing the national competitiveness, improving the quality of clinical trial, and encouraging researches on drug development for gastritis.

• Journal of the Korea Safety Management & Science
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• v.17 no.1
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• pp.215-224
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• 2015

International organization and airport operator have issued a guidance manual with regard to the sustainability specialized in airport by adopting environment friendly rating system and developing a variety of sustainable practices. The structure of framework is essential to the development of practical and effective sustainability guideline of airport. Evaluation criteria and method for airport sustainability properly designed is necessary for the assurance of the level of sustainability. In this study, evaluation criteria and method proper to airport after structuring of framework for airport sustainability will be suggested by reviewing a variety of reference documents issued from foreign and domestic organization.

• Journal of Families and Better Life
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• v.22 no.4
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• pp.15-27
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• 2004

This study investigated the factors in evaluating internet shopping mall sites, and developed a self-report evaluation scale of such sites, This article identifies factors to determine criteria for evaluating the sites from the consumers' viewpoint. Eighty three items were extracted initially, which were then categorized as follows: \circled1 Type of business, \circled2 Navigation ease, \circled3 Technological level, \circled4 Design of sites, \circled5 Communication ease, \circled6 Information available, \circled7 Ease of access, and \circled8 Site security, Overall reliability coefficients were high in the individual domains ($\alpha$=.86 to $\alpha$=.95). Face validity and contents validity were demonstrated to be good, There were significant differences in the means of these categories. The results also show that the technological level is the most important in shopping mall sites evaluation. These results may be used not only as a tool to evaluate shopping mall sites but also as a guideline to improve the quality of a shopping mall site that is under development.

• Journal of the Korea Institute of Information and Communication Engineering
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• v.9 no.6
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• pp.1226-1233
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• 2005

The purpose of this paper is to overview the recently changed environments of developing a computer game software and propose an appropriate developemnt methodology to these environments. For the speed of playing 3-dimensional games in window-based environments of personal computer, we investigated DirectX as a game development library and suggested a guideline for developing 3-dimensional computer games which is compatible with various hardware platforms and keep up a fitting speed of game-playing.

• Proceedings of the Korean Society for Noise and Vibration Engineering Conference
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• 2013.10a
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• pp.769-772
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• 2013

When developing engine mount, interm mount bracket 1st resonance is critical to make sound quality better or worse. So, at the initial stage of development, we need to consider some design parameter to setup the target of interm bracket 1st resonance. Especially, 3cylinder interm bracket guideline is not well known. So, this paper deals with some important sensitivity which should be considered during the development of vehicle. From source to interior side, we should know the component sensitivity like body sensitivity p/F or bracket gain etc. Through this paper, we could get the knowledge of design guideline and key consideration points.

• Urogenital Tract Infection
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• v.13 no.3
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• pp.45-50
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• 2018

The Institute of Medicine in its report "Clinical Practice Guidelines we can trust" defined standards for clinical practice guidelines. However, many guidelines continue to rely on expert opinion and lack a formal framework for moving from evidence to recommendations. These guidelines may or may not be labeled as "consensus statements" and do not meet contemporary standards for guideline documents we would refer to as "evidence-based". Therefore, the Grading of Recommendations Assessment, Development and Evaluation working group developed a novel, rigorous and transparent approach to grading certainty (quality) of evidence. In addition, it created a system for "moving from evidence to decisions", for example for the development of evidence-based guidelines. In this article, we aim to introduce this approach to appraising the certainty of relevant evidence and estimate the benefits and detriments of health care interventions within the larger context of evidence-based medicine.

• Korean Journal of Radiology
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• v.20 no.6
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• pp.909-915
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• 2019

The Korean Society of Radiology and the National Evidence-based Healthcare Collaborating Agency developed a primary imaging test for suspected traumatic thoracolumbar spine injury. This guideline was developed using an adaptation process involving collaboration between the development committee and the working group. The development committee, consisting of research methodology experts, established the overall plan and provided support on research methodology. The working group, composed of radiologists with expertise in musculoskeletal imaging, wrote the recommendation. The guidelines recommend that thoracolumbar spine computed tomography without intravenous contrast enhancement be the first-line imaging modality for diagnosing traumatic thoracolumbar spine injury in adults.

• The Journal of Korean Medicine
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• v.40 no.1
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• pp.153-173
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• 2019

Objectives: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer" by analyzing the existing guidelines and clinical trials. Methods: The committee searched guidelines and clinical trials about herbal medicine for lung cancer. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of our analysis with the guidelines to identify the issues we will have to consider when making the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer". Several guidelines for anti-tumor agents and clinical trials with herbal medicine were searched on the national institution homepage. The search terms were as follows: 'lung neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional' etc. Results: There was no guideline for clinical trial with herbal medicine for lung cancer. In addition, 7 articles were searched through database searching. All the participants had non-small cell lung cancer. The type of intervention was decoction. Comparators included conventional treatments such as chemotherapy. The outcome measurements used in the studies were quality of life, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events and blood test. Conclusions: Findings were made by reviewing existing guidelines and comparing them with clinical trials for lung cancer and herbal medicinal products. These results will be utilized in the development of "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer".