• 대한의용생체공학회:의공학회지
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• 제40권6호
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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.

• 해양환경안전학회지
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• 제28권6호
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• pp.973-991
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• 2022

전 세계적으로 해상을 마주하고 있는 여러 국가들은 기존의 전력 생산방식의 단점을 극복하고 해상풍력 개발을 통한 친환경에너지자원을 활용하고 있다. 해상은 넓은 해역에 대규모 풍력단지를 개발할 수 있는 장점이 있으나 해양구조물의 설치로 인해 선박의 안전운항이 위협받고 있다. 이에 따라, 선박 통항로와 해상풍력단지 간 상호 미치는 영향에 대해 분석하여 선박이 안전하게 운항할 수 있도록 PIANC에서는 표준 Guideline을 제시하였다. 그럼에도 불구하고, 표준 Guideline은 모든상황에서 동일한 이격거리를 산정하였다. 따라서 본 연구에서는 선회성능, 조우상태, 환경외력, 해상밀집도, 해상풍력발전기, 항로형태 등을 요소로 반영한 선박 통항로와 해상풍력단지 간 최적의 이격거리 산정 모델을 개발하였다. 개발된 모델 검증을 위한 시뮬레이션 결과, 운항 준비상태에 따른 입지 특성별 선회성능 크기는 산정 모델에서 제시한 크기와 유사하였다.

• 약학회지
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• 제55권4호
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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.

• 대한안전경영과학회지
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• 제17권1호
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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.

• 가정과삶의질연구
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• 제22권4호
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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.

• 한국정보통신학회논문지
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• 제9권6호
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• pp.1226-1233
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• 2005

본 논문은 3차원 레이싱게임을 위한 최근 변화된 게임 개발환경과 그에 따라 달라진 3차원 컴퓨터게임 개발 방법을 모색한다. PC 환경 하에서 게임의 속도구현을 위한 3차원 게임 라이브러리 DirectX의 사용과 윈도우즈 환경 하에서의 게임개발 방법을 고찰함으로써 사용자 게임실행시의 다양한 하드웨어 환경을 지원하고, 유효한 게임실행 속도를 얻을 수 있는 3차원 컴퓨터게임의 개발방법론을 제시하였다.

• 한국소음진동공학회:학술대회논문집
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• 한국소음진동공학회 2013년도 추계학술대회 논문집
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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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• 제13권3호
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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.

• 대한한의학회지
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• 제40권1호
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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".

• 한국임상약학회지
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• 제25권3호
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• pp.178-186
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• 2015

Objective: Clinical practice guidelines (CPGs) are systematically developed statements aimed at helping optimal care of the patient in a given clinical circumstance. Because of the increasing evidence that active implementation of CPGs improve health outcomes, there is a growing awareness of the importance of guideline development and dissemination. The objective of this study was to investigate the status of CPG development and availability of the CPGs in Korea. Method: We searched in the Web sites of 180 organizations to identify CPGs which were developed and/or published in Korea until 1 July 2014. The data of titles, published year, publisher, distributer, and accessibility at the internet web of all CPGs were collected and analyzed. Results: A total of 172 CPGs were developed and 80% had been released since 2009. Most (51.2%) were developed for management of 4 diseases: 28 for digestive system disease; 27 for infectious disease; 18 for endocrine and metabolic diseases; and 15 for neoplasms. Of the 172 CPGs, 150 CPGs were publicly available. Among the 150 CPGs, 78.7% (118/150) were developed by only one organization. Conclusion: To ensure the production of high-quality CPGs, it is necessary to collaborate with other relevant professional societies in guideline development process. In addition, stronger efforts on wider dissemination of CPGs must be employed at the country levels to promote implementation of CPGs in clinical settings.