• Title/Summary/Keyword: Sameness

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Usefulness of SUPAC-SS in Dealing with Postapproval Changes to Semisold Dosage Forms (반고형 제제의 제품허가 후 변경사항을 다루는 SUPAC-SS)

  • Cho, Mi-Hyun;Suk, Kui-Duk;Sah, Hong-Kee
    • Journal of Pharmaceutical Investigation
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    • v.35 no.3
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    • pp.207-224
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    • 2005
  • The objective of this study was to explore the principles of SUPAC-SS and its regulatory application in handling postapproval changes to nonsterile semisolid dosage forms. The types of postapproval changes that SUPAC-SS described were modifications in formulation (components and composition), batch size, manufacturing equipment & process, and the site of manufacturing. SUPAC-SS defined the levels of postapproval changes and what chemistry, manufacturing, and control tests should be conducted for each change level. The guidance also specified several occasions the manufacturers should perform in vitro release test (Franz cell diffusion test) and/or in vivo bioequivalence test. Finally, SUPAC-SS classified appropriate filing forms to be used in supporting postapproval changes. It was crystal clear that SUPAC-SS helped maintain the safety and quality of approved semisolid dosage forms when they were subject to certain postapproval changes. The availability of SUPAC-SS made contributions to reducing regulatory burdens of the industry, as well as expediting the postapproval process of regulatory agencies. This study also shed light on the background of relevant pharmaceutical sciences that the SUPAC-SS guidance adopted. Finally, the KFDA and the industry were strongly urged to implant a similar guidance in handling postapproval changes to semisolid dosage forms available in the Korean marketplace.

A Study on Value Systems of Police Officers in Korea (우리나라 경찰관의 가치관에 대한 연구)

  • Sin, Seong-Won
    • Proceedings of the Korea Contents Association Conference
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    • 2009.05a
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    • pp.543-548
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    • 2009
  • The aim of this study is to make use of the theory of human values developed by Rokeach as a theoretical framework to evaluate value preferences among police officers in Korea and have a thorough grasp of the point of sameness and difference with two studies. In this study, I analyze data and make a comparative study of values with preceding studies. I find that police officers regard personal values as more important than social values. A noticeable finding of this study is the middle ranking of the value of equality among police officers. It's different result with other studies. And, the value of national security is the low ranking among police officers. It's the same result with preceding studies.

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A Study on Recognition of Autism Spectrum Disorder Among Infants and Toddlers by Childcare Teachers : With a Focus on Focus Group Interviews (보육교사의 영유아 자폐스펙트럼장애 인식에 관한 연구: 포커스 그룹 인터뷰(FGI)를 중심으로)

  • Lee, Kyung-Sook;Park, Jin-Ah
    • Korean Journal of Childcare and Education
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    • v.12 no.3
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    • pp.211-238
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    • 2016
  • This study examines indicators and factors for identification of ASD(Autism Spectrum Disorder) characteristics of infants and toddlers and early screening of children with ASD by day care teachers. Focus group interviews were conducted with 11 teachers by a semi-structured questionnaire developed by the authors. The findings are: 1) key problems and indicators of behavioral characteristics of children with ASD included problems with social communication and interactions, restricted and unusual interests, outstanding ability in specific areas, insistence on sameness and ritualized patterns, problems with language development and communication, sensory abnormalities; 2) counseling with parents of children with ASD revealed a lack of recognition of parents, negative expressions of emotions and resistance, and difficulties in referral to and association with experts; 3) needs for ASD in the child care field included visiting by experts, provision of test scales, training of child care teachers and parents, and building cooperative systems; and 4) demands of development and execution of a Korean-style scale for early screening of children with ASD.

Clinical Implications of Social Communication Disorder (사회적 의사소통장애의 임상적 이해)

  • Shin, Suk-Ho
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • v.28 no.4
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    • pp.192-196
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    • 2017
  • Social (pragmatic) communication disorder (SCD) is a new diagnosis included under communication disorders in the neurodevelopmental disorders section of Diagnostic and Statistical Manual of Mental Disorders-5. SCD is defined as a primary deficit in the social use of nonverbal and verbal communication. SCD has very much in common with pragmatic language impairment, which is characterized by difficulties in understanding and using language in context and following the social rules of language, despite relative strengths in word knowledge and grammar. SCD and Autism Spectrum Disorder (ASD) are similar in that they both involve deficits in social communication skills, however individuals with SCD do not demonstrate restricted interests, repetitive behaviors, insistence on sameness, or sensory abnormalities. It is essential to rule out a diagnosis of ASD by verifying the lack of these additional symptoms, current or past. The criteria for SCD are qualitatively different from those of ASD and are not equivalent to those of mild ASD. It is clinically important that SCD should be differentiated from high-functioning ASD (such as Asperger syndrome) and nonverbal learning disabilities. The ultimate goals are the refinement of the conceptualization, development and validation of assessment tools and interventions, and obtaining a comprehensive understanding of the shared and unique etiologic factors for SCD in relation to those of other neurodevelopmental disorders.

A Study on Non-Representational Characteristics that Appears in the Design of Gaetano Pesce (가에타노 페세의 디자인에서 나타나는 비재현성에 관한 연구)

  • Park, So-La
    • Korean Institute of Interior Design Journal
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    • v.22 no.5
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    • pp.106-113
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    • 2013
  • Since the 1960's, diverse movements that oppose the uniform design tendency of modernism appears in Italy. Especially, Gaetano Pesce, who opposed uniformity and standardization that are based on mass production system, had interests in making unique product, not an identical product, while accepting modern production technology. Therefore, the purpose of this study is to comprehend Pesce's design, which creates diversity by arranging contingent, non-predictive, and episodic aspects in creative and acceptance processes according to the intension of the designer within mass production system, as a non-representational characteristic, which appears widely in modern thought and the arts, and examine how it is materialized in detailed design work. The study methods are first examining non-representation with theoretical contemplation and dealing with the design philosophy of Pesce based on the examination. Next, in order to discover non-representational characteristics that appear in the work of Pesce, it examines from introducing worker's creativity, user's possibility of choice, openness in the working process, and the aspects of researching materials. And a specific application method will be drawn through case analysis centered on furniture design. Gaetano Pesce's design that denies the world of representation based on the sameness comes to possess non-representational characteristics that acknowledge contingency and ceaselessly create difference by intentionally arranging during the working process.

Gestalt Group Meditation Therapy Effect on Occupational Stress and Anxiety in Working Women

  • Kim, Sung-Bong
    • International Journal of Contents
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    • v.5 no.4
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    • pp.44-50
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    • 2009
  • The purpose of this research was to measure the effect of a gestalt group meditation therapy intervention program on occupational stress and anxiety in working women aged 30 to 49 in Korea. Scientific methods were employed to test a gestalt group meditation therapy intervention program as treatment for working women in 30-40s to reduce their level of occupational stress and anxiety. The study involved 18 volunteer subjects ages of 30 to 49 years, randomly divided into two groups: (1) gestalt group meditation therapy intervention program, and (2) no program. Both groups completed a pre-test and a post-test of occupational stress scale and trait anxiety inventory. The outcome data was analyzed as qual1litative information using the SPSSPC+ computer program. Mann-Whitney U test was used to analyze the result in order to verify the sameness between experienced group and controlled group of pre-test scores within the groups. Also U-test comparisons were used to analyze the treatment effects. The results of this investigation indicated that (1) occupational stress scores decrease after gestalt group meditation therapy intervention program on the treatment group, and (2) trait-anxiety scores decrease after gestalt group meditation therapy intervention program on the treatment group. In summary, the gestalt group meditation therapy intervention program for career women, aged 30 to 49, in Korea could reduce the subjects' occupational stress and anxiety.

A Historical Analysis of Barrow's Theorem and Its Educational Implication (Barrow 정리의 수학사적 분석과 그에 따른 교육적 시사점에 대한 연구)

  • Park, SunYong
    • Journal for History of Mathematics
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    • v.26 no.1
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    • pp.85-101
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    • 2013
  • This study is to analyse the characteristics of Barrow's theorem on the historical standpoint of hermeneutics and to discuss the teaching-learning sequence for guiding students to reinvent the calculus according to historico-genetic principle. By the historical analysis on the Barrow's theorem, we show the geometric feature of the theorem, conjecture the Barrow's intention in dealing with it, and consider the epistemological obstacles undergone by Barrow. On a basis of this result, we suggest a purposeful and meaning-oriented teaching-learning way for students to realize the sameness of the 'integration' and 'anti-differentiation', and point out the shortcomings and supplement point in current School Mathematic Calculus.

A Study on the Characteristics of Interior Finnishing Materials on Restaurant in Multi-use Facillity (다중이용시설로서의 레스토랑 실내건축의 내장재 특성에 관한 연구 - 창원시 상남일반상업지역을 대상으로 -)

  • Kim Dong-Han;Ko In-Seok;Seo You-Seok
    • Korean Institute of Interior Design Journal
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    • v.15 no.3 s.56
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    • pp.24-32
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    • 2006
  • Through the increasing of social economies and cultural activities, the Food service industry have been growing up steadily in spite of low economic activity. This is owing to increasing income, participation of women in public affairs and a dual-income family, automobile culture, desire for healthful food, shorten working hours, changing of cultural style. Moreover, the recent importance of Interior finishing materials by means of fire in the Restaurant, legal fractional multiple use business establishment are recognized of publicity. Therefore, This Study aim object at probing into the characteristic of Interior finishing material and then analysing the characteristics of space and material according to the typical distribution. In the Interior planning of Restaurant, firstly it is need to probe the Characteristics of interior finishing material at the basic element. This study is going to apprehend the constitution of space and difference of proportion or a point of sameness in the characteristics of material. Moreover, the recent importance of Interior finishing materials by means of fire in the Restaurant, legal fractional multiple use business establishment are recognized of publicity. Throughout probe and analysing, it can append more efficiency and elasticity in the usage of interior finishing material.

The Analysis of the TETRA Authentication Protocol (TETRA 인증 프로토콜 분석)

  • Park Yong-Seok;Ahn Jae-Hwan;Jung Chang-Ho;Ahn Joung-Chul
    • Journal of the Korea Institute of Information and Communication Engineering
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    • v.10 no.6
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    • pp.1070-1075
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    • 2006
  • TETRA system provides the radio authentication service which permits only authorized radio to access network. Radio authentication is the process which checks the sameness of authentication-key(K) shared between radio and authentication center by challenge-response protocol. TETRA standard authentication protocol can prevent the clone radio to copy ISSI from accessing network, but can't prevent the clone radio to copy ISSI & authentication-key. This paper analyzes authentication-key generation/delivery/infection model in TETRA authentication system and analyzes the threat of clone radio caused by authentication-key exposure. Finally we propose the new authentication protocol which prevent the clone radio to copy ISSI & authentication-key from accessing network.

A Study on the Issues on the Right of Portrait for Performing Arts Archives (공연예술기록의 초상권에 관한 연구)

  • Lee, Ho-Sin
    • Journal of Korean Library and Information Science Society
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    • v.44 no.1
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    • pp.333-355
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    • 2013
  • This paper is to examine the issues of the right of portrait and to suppose practical guideline for performing arts archives. The right of portrait protects external looks of the human beings based on the constitutional human dignity, privacy of a secret and freedom. But sometimes these rights are limited in case of the right to know of the public shall have precedence to the interests of the privacy of individuals. It is hard to regard Performing Arts as a private life in two respects: first, Performing Arts is just one of societal expressions, two, performers are conducting a given role as a performing character. Producing database with the photos and videos under the reasonable agreement from the performers and making it available as a service can be disclaimers of the right of portrait. It is hard to be acknowledged, however, as disclaimers in case of being undermined sameness in the course of using the portraits of the performers.