Earticle

The biopharmaceutical drugs which are produced by recombinant DNA technology or new biotechnology and used for the treatment of human diseases have developed since 1980s, and successfully introduced in drug market. Some of them became blockbuster drugs and have entered in the category of major drugs having a grand market size. In this study, the registry of the biopharmaceutical drugs in official compendium including Korean Pharmacopoeia was investigated by comparing foreign pharmacopoeias such as US Pharmacopoeia, European Pharmacopoeia and Japanese Pharmacopoeia. In Korea, biologic drugs have been regulated by the official notification[The Criteria and Test of Biologics\, and the recombinant pharmaceuticals has been also regulated in this notification. However, the market expansion of drugs in this category requires the official registry in the official compendium. In this article, the necessity of registration of some selected biopharmaceuticals in the official compendium is addressed, and the consideration points in general notices, general rules of preparations, general tests and general information of Korean Pharmacopoeia is suggested. In addition, the registration of biosimilar drugs in official compendium, for example in Korean Pharmaceutical Codex, is also proposed, for taking action on the market entrance of biosimilar drugs following the expiration of patent of oldest biopharmaceutical drugs. This will be helpful in more effective management and regulation of biopharmaceutical drugs and in harmonization with international requirements.

Good records management is essential for good governance in modern democratic society. Though the records management institutions and policies in Korea were improved rapidly since the enactment of Public Records Management Act in 1999, the newly introduced records systems for administrative organizations including the New Electronic Data Management System(NEDMS) and Electronic Records Management Systems for Records Centers(ERMS/RC) have many problems in terms of ensuring the quality of records. The purpose of this study aimed to suggest quality criteria for measuring authenticity, reliability, integrity and usability of electronic records based on the international standards and guidelines such as ISO 15489, InterPARES project and BS ISO 15489 guidelines. The present study began with defining concepts and structure of records as evidence of activities. And it analysed four characteristics such as authenticity, reliability, integrity and usability of records by comparing various definitions in diplomatics and archival science literatures, and some projects reports. Finally it suggested the quality criteria for measuring authenticity, reliability, integrity and usability of records, and methods for maintaining them in each process of creation, maintenance and preservation.

진술분석은 진술 내용을 기반으로 진술에 나타나는 문제, 심리적 특징 등을 과학적으로 분석하여 진술의 신빙성을 밝히는 분석 기법으로, 물적증거의 확보가 어려운 아동(13세 미만) 및 장애인 성폭력 피해 의심사건이 발생했을 때 법적 판단에 활용되고 있다. 그러나 국내에서 진술분석 보고서와 같은 법심리학적 평가 보고서의 질적 우수성을 평가할 수 있는 기준은 존재하지 않는다. 외국의 법심리학적 보고서에 대한 다수의 연구에서 보고서에 필수적인 내용이 누락되거나 빈약하게 기술되어 있는 경우가 존재하고, 법심리학적 의견과 평가결과 간의 논리적 연결성 부족 등 보고서의 질이 확보되지 않는 문제점이 공통으로 발견되었다. 이에 본 논문에서는 외국의 지침들과 법정에 제출된 법심리학적 보고서 분석을 통해 법심리학적 보고서의 문제점들을 살펴보았다. 이를 바탕으로 스웨덴의 전문가 증언의 구조화된 질적 평가도구(Structured Quality assessment of eXpert testimony; SQX-12)를 재분석하고, 선행연구에서 밝혀진 한계를 종합해 한국에서 사용 가능한 ‘한국 진술분석 전문가 보고서 및 증언에 대한 질적 평가 기준’을 제안하고자 한다. 이와 같은 질적 평가 기준의 제시는 사법적 판단 시 법심리학적 보고서의 법적 효용성을 높이고, 전문가가 보고서와 전문가 증언의 질을 확인할 수 있는 수단으로 활용될 수 있을 것이다. 그러나 이 기준들에 의해 보고서가 충실히 작성되었다고 해서, 진술 내용 자체의 신빙성을 담보하는 것은 아니다.

Statement analysis is a technique that examines the credibility of a statement by scientifically analyzing problems and psychological characteristics that appear in the content of the statement. The statement analysis report is prepared, submitted, and used for legal judgments when there is a suspicion of sexual abuse for children(under 13 years of age) and persons with disabilities since it is usually difficult to secure physical evidence nor eyewitnesses. However, the criteria for evaluating the quality of a statement analysis report or testimony are not available in Korea. Although forensic experts and professional organizations in North America and Europe are providing recommendations and guidelines for preparing forensic assessment reports, qualitative analysis research studies for forensic reports revealed a number of problems such as missing or poorly described essential information and lack of logical connection between evaluation results and forensic opinions. Therefore, forensic evaluation guidelines and forensic reports submitted to the courts in the United States, as well as the Structured Quality assessment of eXpert testimony (SQX-12) developed in Sweden were examined to suggest the Korean version of quality evaluation criteria for statement analysis report and testimony. This criteria can be used to improve effectiveness of forensic reports within criminal justice system and used as a guideline to assess the quality forensic reports or expert testimony prepared by experts. However, this criteria do not guarantee the reliability of the statement itself.

Background: The quality of R. glutinosa can fluctuate based on factors such as cultivation region and harvest timing. This may result in differences in product quality. Therefore, in this study, we aimed to evaluate the quality of fresh R. glutinosa produced in Korea and to establish criteria for establishing standards applicable to the agricultural supply chain. Methods and Results: R. glutinosa ‘Togang’ samples harvested from major production areas were analyzed for rhizome diameter distribution, drying yield, juicing yield, catalpol content, and antiox- idant activity. The rhizomes were classified into five categories according to their diameters, and their production ratios were evaluated. The distributions were as follows: 11–15 ㎜, 5–10 ㎜, 16–20 ㎜, over 20 ㎜ and ≤ 5 ㎜. While there were no significant differences in drying and juicing yields by diameter, the catalpol content was the highest in the 11–15 ? category. The antioxidant content was higher in thin rhizomes with 2,2-azino-bis (3-ethylbenzothiazoline-6-sulfonic acid and 2,2-diphenyl-1-picrylhydrazyl radical scavenging activitites following a similar pattern. Conclusion: In this study, we successfully established a quality evaluation and grading system based on the rhizome diameter. The finding can enable farmers and industry professionals to effi- ciently produce, process, and distribute R. glutinosa, thereby enhancing its industrial applicability and increasing market competitiveness.

본 연구의 목적은 국내 장애인복지법과 장애인고용촉진 및 직업재활법에 의해 요구되는 ‘직장인 대상 장애인식개선교육’의 향상을 위해 ‘장애인식개선교육의 질적 지표’ (quality indicators)를 개발하는 것이다. ‘직장인 대상’ 장애인식개선교육이 법제화된 것에 비해 질 높은 프로그램의 구성요건, 실행 실태조사, 정기적 점검 및 효과 평가에 대한 엄격한 연구는 미미한 경향이었다. 이에 본 연구는 장애인식개선 관련 문헌연구와 전문가 15명을 대상으로 수정된 델파이 조사를 실시하여 장애인식개선교육의 질적 지표를 개발하였다. 델파이 조사지 문항은 연구자들의 선행문헌 분석 및 예비문항 작성과 전문가 협의를 통해 추출되었다. 연구결과는 첫째, 1차와 2차 델파이 조사 결과 장애인식개선교육의 질적 지표가 4가지 하위영역의 25개 지표로 최종 개발되었다. 둘째, 최종 25개 질적 지표의 내용타당도 값(CVR 값)이 모두 0.73 이상으로 높게 나타났고, 수렴도는 0.00-0.50, 합의도는 0.77-1.00으로 전문가들 사이의 25개 질적 지표 내용에 대한 높은 타당도와 합의도가 도출되었다. 이는 국내에서 연구에 기초해 최초로 개발된 25개 질적 지표로서 우리나라 실정에 맞는 현재와 미래의 질 높은 장애인식개선교육의 개발, 선택 및 실시를 위해 최소한의 질적 기준과 지침으로 적용될 수 있다. 본 연구는 직장인의 장애인식개선교육을 어떻게 향상시킬 것인가에 대해 전문가 패널로부터 최소한의 합의점을 처음으로 이끌어낸 의의가 있다. 이에 직장인 대상 장애인식개선교육 프로그램에 대해 4가지 하위영역: ‘교육목표 및 기대효과’, ‘장애에 대한 관점’, ‘교육내용’, ‘교수방법 및 평가’의 25개 질적 지표에 기반해 장애인식개선교육의 최선의 실제(best practices)를 향한 프로그램 질 제고를 촉구할 것이 기대되며, 장애인식개선교육의 성과로 기대하는 장애에 대한 ‘긍정적 인식’이란 과연 ‘무엇인지’ 구체적 기준을 국내에서 처음으로 제시하는 의의가 있다.

The purpose of this study was to develop and validate the quality indicators for disability-awareness programs(DAP) in the workplace which is required by educational institutions and public organizations in accordance with the laws. However, rigorous research on the development and implementation of high quality programs, surveys on implementation status, monitoring of DAP tended to be insufficient. Thus, a revised Delphi was conducted twice to identify and validate the quality indicators for DAP, and 15 professors and field experts participated. The Delphi questionnaire was confirmed through a literature review and expert meeting. The results are as follows. First, 25 quality indicators for DAP in the workplace were developed in 4 areas. Second, the content validity(CVR) were all higher than 0.73, with convergence of 0.00-0.50 and agreement of 0.77-1.00. High validity and agreement were obtained for the contents of the 25 indicators among expert panels. The 25 quality indicators can be applied as the minimum quality standards and guidelines for the development and implementation of current and future DAP in workplaces. This study is significant in that it was the first to derive the minimum consensus from expert panels on how to improve disability awareness in nationwide workplaces. It is expected that the 25 quality indicators will prompt improvement in DAP towards the best practices in four sub-areas: goals and outcomes, perspectives on disability, contents, and teaching strategies and evaluation. This study presents for the first time in the field of disabilities in Korea what the positive perceptions of disability is expected as an outcome of the DAP.

지금까지 이러닝 소프트웨어 평가에 관한 다양한 연구가 진행되었으나 관련 표준에 따라 체계화된 형태가 아닌 연구자의 시각에서 제시된 분류에 따라 주관적인 평가 기준을 구성하고 있다. 또한 소프트웨어 평가 관련 표준도 실질적인 활용을 위해 지속적으로 보완되고 있으므로 이에 부합하는 평가 기준의 마련을 통해 평가 근거의 확보 및 체계화가 절실하다. 따라서 본 연구에서는 이러닝 소프트웨어의 품질평가 기준을 구축하기 위해 소프트웨어 제품평가 표준인 ISO/IEC 25000 시리즈의 품질특성 중 사용성에 관한 체계를 근간으로 하고 이러닝 소프트웨어의 품질 요구사항을 분석하고 체계화하여 사 용성의 부특성에 따른 평가 기준을 구축하였다. 본 평가 기준은 지속적으로 변화하는 관련 최신 표준화 동향을 반영한 이러 닝 소프트웨어 평가기준을 구축하여 실질적인 활용도를 제고했다는 점에서 차별화된다. 향후 이러닝 소프트웨어의 품질평가 및 인증에 효과적인 활용이 가능할 것으로 사료된다.

So far, various researches have been conducted on evaluation of e-learning software, but subjective evaluation criteria are formed according to the classification presented from the viewpoint of the researcher rather than systematized form according to related standards. In addition, standards for software evaluation are continuously being supplemented for practical use, so it is urgent to establish evaluation bases by establishing evaluation criteria. Therefore, in order to establish the quality evaluation standard of e-learning software, this study analyzes the quality requirements of e-learning software based on the usability system among the quality characteristics of ISO/IEC 25000 series. This evaluation standard is distinguished by the fact that the evaluation standard of e-learning software that reflects the latest trend of related standardization has been established and practical utilization has been improved. It can be used effectively for quality evaluation and certification of e-learning software in the future.

Many studies have found that regardless of who the evaluator is― interpreter or the service user―content-related criteria are deemed the most important in assessing interpreting quality. However, it must be noted that service users, in most cases, do not understand the source language. Naturally, this means that service users are in a disadvantageous position to evaluate the content-related quality of interpreting as they cannot compare the contents of the target text against the source text. The purpose of this study is to investigate how the service user evaluates the content-related quality of interpreting without having access to the source text. Through the use of structural equation modeling, this study shows that service users depend on the form-related criteria and not on the delivery-related criteria to guess how well the original message was delivered content-wise. Furthermore, it is found that when the interpreter fails to maintain a constant rate of speech, the service users regard it as a sign of drop in sense consistency.

본 연구는 다양한 모바일 기기 기반으로 서비스되는 콘텐츠들의 품질을 높이기 위해 고려해야 할 요인이 무엇인지를 규 명하고자 하였다. 연구 목적 달성을 위해 본 연구는 전문가 델파이를 통해 12개의 평가영역, 26개의 평가 항목을 도출하 였다. 본 연구를 통해 도출된 평가기준은 교육적 콘텐츠의 품질을 높이는 데 기여할 수 있을 것이다.

The purpose of this study was to examine what should be considered to boost the quality of mobile device based e-learning contents. For this study, 12 evaluation domains and 26 evaluation items were selected using the Delphi method. The findings of this study are expected to contribute to the improvement of the quality of the educational contents.

본 연구에서는 사회과학에서 사용되는 해석적 연구 방법론의 핵심 개념들을 서술하고 기 존의 중요 문헌들을 검토하여 해석적 연구의 질을 판단하는 기준들을 소개하였으며, 그것들 을 본 연구에서 정한 기준에 입각하여 재분류하였다. 해석적 연구 방법론의 핵심 개념들은 전통적인 주관주의적 철학 분야에 속하는 존재론과 인식론, 그리고 그것들의 응용 분야인 방법론에 관한 내용이다. 1980년대 중반부터 연구되어 온 질적 연구자들과 이후에 시작된 해석적 연구자들이 개발해 온 해석적 연구의 평가 기준 인 질적 기준은 매우 다양하다. 특히 자연주의, 현상학, 비판적 실재론, 실용주의, 탈근대주의 등 다양한 철학이 각 기준의 배경으로 자리하고 있다. 본 연구에서는 이들 해석적 연구의 질 판단 기준들과 기법들을 재분류하는 시도를 하였는데 그 시도는 실증주의 방법론에서의 발견의 논리와 정당화의 논리에 비견되는 것으로 해석의 논리와 이 해의 논리로 구별한 것이다. 해석의 논리에 속하는 기준들로는 중층기술, 성찰 및 상호 검토이고, 이해의 논리에 속하는 기준들로는 진정성, 이전성 및 행동 정향이다. 한편 이러한 시도는 해석적 연구에서 처음 이루어지는 것이다. 따라서 이에 대한 더 깊은 논의와 비판적 검토를 거쳐 이해 및 해석의 논리 구별 뿐 아니라 그 각각에 속하는 기준들을 정교화해 나아가야 할 것으로 보인다.

This study attempts to describe core concepts of interpretive methodology, to review existing literatures about criteria of quality of interpretive research, to reclassify them by two logics(interpretation and understanding). Core concepts of interpretive methodology are based on ontology, epistemology of traditional subjective philosophy, including applied field of them(methodology). Qualitative and interpretive researchers have argued and developed criteria of quality of interpretive research since mid-1980s. But the criteria are so much various and multiple, namely, each group of criteria are based on naturalism, phenomenology, critical realism, pragmatism, and post-modernism. Reclassification of these many criteria was attempted in this study by two logics, logic of interpretation and logic of understanding. Thick description, reflexivity, and mutual review are subject to logic of interpretation. Authenticity, transferability, and action orientation are subject to logic of understanding. This reclassification should be reviewed by many commentators, and must be elaborated in the future.

The purpose of this study is to investigate whether the results of survey on interpreters' expectations match the interpreters' evaluation of a given interpreting performance. Many expectation surveys on interpreting quality criteria have shown that interpreters and users alike regard the content-related group more important than the form-related group and the delivery-related group. However, to see whether these criteria ratings hold true in real-world evaluations, we need to have interpreters or users evaluate actual interpreting performances and examine the effect of individual quality items on the overall performance scores. Results of the expectation survey showed that the content-related group was deemed more important than the form-related and the delivery-related groups, which is consistent with previous studies. Results of the interpreter's evaluations on English-to-Korean interpretations showed that the content-related group had the largest effect on the total score, followed by the form-related group and the delivery-related group. In contrast, results of the interpreter's evaluations on Korean-to-English interpretations showed that the form-related group had the largest effect on the total score, followed by the content-related group and the delivery-related group.

본 연구는 프랑스의 품질인증 가이드라인과 한국의 품질인증 평가준거를 비교하고, 이러닝 품질관리에 대한 표준화된 이러닝 품질인증 평가준거를 적용한 품질인증 제도에서 품질인증에 성공한 사례와 실패한 사례를 비교분석 함으로써 이러닝 품질인증 평가준거에 대한 주요 평가영역과 평가항목을 구별하였다. 이를 근거로 프랑스의 품질인 증 평가항목에서 반영해야할 이러닝 품질인증 평가준거, 평가영역, 평가항목에 대한 일반화 모형을 개발하였다. 이는 우리나라는 물론 AUF와 관련이 있는 아프리카나 아시아 국가들에게 그들이 응용할 수 있는 평가준거를 제시한 것 이다. 본 연구의 결과는 이러닝 품질인증 제도를 시행하려는 전 세계의 기관들이 활용할 수 있을 것이며, 동시에 이 러닝 품질인증 평가를 받고자 하는 이러닝 관련 기업이나 기관들에게 중요한 활용자료가 될 것이다.

This study identified the important categories and items about evaluation criteria of e-learning quality assurance by comparing evaluation criteria between Korea and France case. For deriving the conclusion, this research analyzed the Korea quality assurance case which is consist of success or failure for evaluation of quality assurance, and built the generic quality model of e-learning evaluation criteria. A generic model about evaluation criteria, categories, and item of e-learning quality assurance, which should be reflected on French quality criteria, were developed based on statistical approach. This research suggests a evaluation criteria which can be applied to African and Asian countries, that are related to AUF, as well as Korea. The result of this study can be applied to all organizations around the world which prepare for e-learning quality assurance, and at the same time it will be a valuable resource for companies or institutions which want to be evaluated e-learning quality assurance.

This study introduces 2007 criteria of Malcom Baldridge National Quality Award (MBNQA) for performance excellence. Baldridge criteria is composed of the seven categories such as leadership, strategic planning, customer and market focus, measurement, analysis, and knowledge management, workforce focus, process management, and results. Moreover this paper proposes various integrated systems with MBNQA.

이 연구에서는 새롭게 Asian Working Group for Sarcopenia에서 제시한 수정된 근감소증 진단 cut-off value를 이용하여 정상 집단과 근력이 저하된 possible sarcopenia(PS) 집단을 구분하였다. 국민건강영양조사 제 7기 자료를 토대로, 집단간 신체적 특성의 차이와 삶의 질, 유·무산소 운동 실천에 따른 교차비를 산출하였다. 대상자는 20 세-80세까지를 포함하였다. 집단간 차이는 복합표본 독립 t-test와 logistic 회귀분석을 통해 확인하였다. 그 결과는 PS 집단은 나이가 더 많았으며, 신장, 체중, 체질량지수가 모두 낮았다. 허리둘레는 남성 PS 집단이 유의하게 낮았으나, 여성 PS 집단이 유의하게 높았다. 삶의 질의 영역 중 운동 능력에서 일상활동에 지장이 있는 경우가 남성에서는 8.28배, 여성에서는 15.52배 높았다. 유산소 운동의 실천 여부도 PS 집단에서 남녀 각각 19%, 26% 더 낮았으며, 근력 운동 실천 여부도 남녀 각각 52%, 43% 더 낮았다.

In this study, the normal group and possible sarcopenia(PS) group were divided by the criteria for sarcopenia diagnostic based on the 7th period data of the National Health and Nutrition Examination Survey. An independent t-test and logistic regression was performed for the difference between the two groups. As a result, the PS group was older, and height, weight, and BMI were all lower. The waist circumference was significantly lower in men but significantly higher in women. According to the quality of life by domain, the frequency of impairment in daily activities in exercise capacity was 8.28 fold in men and 15.52 fold in women. In addition, aerobic exercise regularity was 19% and 26% lower in the PS, and strength exercise regularity was practiced was 52% and 43% lower.

In this study, two things were analyzed for Korean Standards certification factory review evaluation items. First, it was examined whether there is a difference between the Practice of factory review evaluation items and Post-Management according to the change in perception of the factory review evaluation items of Korean Standards certification personnel. Second, the moderating effect of the Korean Standards certification personnel's perception of the effect of the Practice of the factory review evaluation items of Korean Standards certification personnel on Post-Management was verified. Although there is a statistically significant difference between Practice and Post-Management according to changes in perception of Korean Standards personnel, there is no statistically significant difference in the impact (slope) of Practice on Post-Management according to changes in perception of Korean Standards certification personnel. As the perception of factory review evaluation items increases, the Practice and Post-Management of factory review evaluation items are increasing, but the impact of the Practice of factory review evaluation items on Post-Management does not affect it. In order to further advance Korean Standards certification, which plays an important role in maintaining the quality level of products produced by companies, efforts to raise the level of perception of Korean Standards certification personnel are considered necessary.

Web Services are applications that perform desired tasks. Such as basic network connectivity to sophisticated compound tasks. Service Composition is the construction of complex services to enable different tasks. Therefore, enabling a rapid and effective composite of services is crucial point in efficiency of composite web services. This paper introduces a new algorithm for effective construction of the primitive services according to their quality criteria. A trust based ranking algorithm is employed to diminish the service with lower qualities.

As diver mobile platforms appear, attention is paid to the development of cross-platform that can be applied to various platforms with one development rather than the development of native application that depends on each platform. Of many frameworks that enable the development of cross-platform, HTML5-based framework is being actively developed as open source project. The present study proposes the evaluation criteria by which the most suitable framework can be selected from many open source projects. In this study, 9 evaluation criteria[14] are proposed, derived from ‘Mobile Software Quality Evaluation Model’, which is based on existing ISO/IEC 25000[3], ‘Evaluation Criteria for quantitatively OSS Selection’ and ‘Mobile Web App Framework Evaluation Standard’. And we were applied to 4 UI frameworks selected from Github Repository to verify the effectiveness of the criteria. This study expects that it can reduce effort required in selecting the most suitable framework and thus increase productivity through proper maintenance supported by the right selection.