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Comparative Study on the Regulations about In-Use Stability, and Analysis the In-Use Stability Application on Approved Syrups - Focused on the Guidelines in US, Europe and Korea - (국내외 의약품 개봉 후 안정성 규정 비교와 국내 시럽제의 안정성 적용 현황 분석 - 미국, 유럽, 한국의 가이드라인을 중심으로 -)

  • Park, Onnuri;Jang, Kyoung won;Ha, Dong mun
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.21 no.3
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    • pp.137-146
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    • 2020
  • Syrup agents are often used after opening, and therefore, there is a high possibility of decreased quality. The Ministry of Food and Drug Safety (MFDS) published guideline on stability testing for pharmaceuticals after opening in December, 2016. We compared guidelines related to the period of use after opening between the United States of America (USA), Europe (EU), and Korea, and we analyzed whether the period of use or storage conditions is stated based on the data of drug approval for 4 dry syrups and 3 large packing syrups before and after the introduction of the guideline. First, in USA and EU, the period of use and storage conditions after opening should be listed on the label on the packaging container (as well as the expiration date), while in Korea, those are included in the area of precautions for use. Second, all of the analyzed drugs were not changed by the guidelines for establishing the new post-opening period of use, and they were only presented for the existing expiration date prior to the establishment of the guideline. Medicines that are used for multiple uses after opening may need improved instructions to ensure that the period of use and storage conditions are listed on the packaging according to stability evaluation after opening.

Model-based Specification of Non-functional Requirements in the Environment of Real-time Collaboration Among Multiple Cyber Physical Systems (사이버 물리 시스템의 실시간 협업 환경에서 소프트웨어 비기능 요구사항의 모델 기반 명세)

  • Nam, Seungwoo;Hong, Jang-Eui
    • Journal of KIISE
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    • v.45 no.1
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    • pp.36-44
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    • 2018
  • Due to the advent of the 4th Industrial Revolution, it is imperative that we aggressively continue to develop state-of-the-art, cutting edge ICT technology relative to autonomous vehicles, intelligent robots, and so forth. Especially, systems based on convergence IT are being developed in the form of CPSs (Cyber Physical Systems) that interwork with sensors and actuators. Since conventional CPS specification only expresses behavior of one system, specification for collaboration and diversity of CPS systems with characteristics of hyper-connectivity and hyper-convergence in the 4th Industrial Revolution has been insufficiently presented. Additionally, behavioral modeling of CPSs that considers more collaborative characteristics has been unachieved in real-time application domains. This study defines the non-functional requirements that should be identified in developing embedded software for real-time constrained collaborating CPSs. These requirements are derived from ISO 25010 standard and formally specified based on state-based timed process. Defined non-functional requirements may be reused to develop the requirements for new embedded software for CPS, that may lead to quality improvement of CPS.

Hardware-Software Cosynthesis of Multitask Multicore SoC with Real-Time Constraints (실시간 제약조건을 갖는 다중태스크 다중코어 SoC의 하드웨어-소프트웨어 통합합성)

  • Lee Choon-Seung;Ha Soon-Hoi
    • Journal of KIISE:Computer Systems and Theory
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    • v.33 no.9
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    • pp.592-607
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    • 2006
  • This paper proposes a technique to select processors and hardware IPs and to map the tasks into the selected processing elements, aming to achieve high performance with minimal system cost when multitask applications with real-time constraints are run on a multicore SoC. Such technique is called to 'Hardware-Software Cosynthesis Technique'. A cosynthesis technique was already presented in our early work [1] where we divide the complex cosynthesis problem into three subproblems and conquer each subproblem separately: selection of appropriate processing components, mapping and scheduling of function blocks to the selected processing component, and schedulability analysis. Despite good features, our previous technique has a serious limitation that a task monopolizes the entire system resource to get the minimum schedule length. But in general we may obtain higher performance in multitask multicore system if independent multiple tasks are running concurrently on different processor cores. In this paper, we present two mapping techniques, task mapping avoidance technique(TMA) and task mapping pinning technique(TMP), which are applicable for general cases with diverse operating policies in a multicore environment. We could obtain significant performance improvement for a multimedia real-time application, multi-channel Digital Video Recorder system and for randomly generated multitask graphs obtained from the related works.

Assessment of the Damage in High Performance Fiber-Reinforced Cement Composite under Compressive Loading Using Acoustic Emission (AE기법에 의한 압축력을 받는 고인성 섬유보강 시멘트 복합체의 손상 평가)

  • Kim, Sun-Woo;Yun, Hyun-Do
    • Journal of the Korea Concrete Institute
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    • v.21 no.5
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    • pp.589-597
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    • 2009
  • High Performance Fiber-reinforced Cement Composite (HPFRCC) shows the multiple crack and damage tolerance capacity due to the interfacial bonding of the fibers to the cement matrix. For practical application, it is needed to investigate the fractural behavior of HPFRCC and understand the micro-mechanism of cement matrix with reinforcing fiber. This study is devoted to the investigation of the AE signals in HPFRCC under monotonic and cyclic uniaxial compressive loading, and total four series were tested. The major experimental parameters include the type and volume fraction of fiber (PE, PVA, SC), the hybrid type and loading pattern. The test results showed that the damage progress by compressive behavior of the HPFRCC is a characteristic for the hybrid fiber type and volume fraction. It is found from acoustic emission (AE) parameter value, that the second and third compressive load cycles resulted in successive decrease of the amplitude as compared with the first compressive load cycle. Also, the AE Kaiser effect existed in HPFRCC specimens up to 80% of its ultimate strength. These observations suggested that the AE Kaiser effect has good potential to be used as a new tool to monitor the loading history of HPFRCC.

The Endophytic Bacteria Bacillus velezensis Lle-9, Isolated from Lilium leucanthum, Harbors Antifungal Activity and Plant Growth-Promoting Effects

  • Khan, Mohammad Sayyar;Gao, Junlian;Chen, Xuqing;Zhang, Mingfang;Yang, Fengping;Du, Yunpeng;Moe, The Su;Munir, Iqbal;Xue, Jing;Zhang, Xiuhai
    • Journal of Microbiology and Biotechnology
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    • v.30 no.5
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    • pp.668-680
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    • 2020
  • Bacillus velezensis is an important plant growth-promoting rhizobacterium with immense potential in agriculture development. In the present study, Bacillus velezensis Lle-9 was isolated from the bulbs of Lilium leucanthum. The isolated strain showed antifungal activities against plant pathogens like Botryosphaeria dothidea, Fusarium oxysporum, Botrytis cinerea and Fusarium fujikuroi. The highest percentage of growth inhibition i.e., 68.56±2.35% was observed against Fusarium oxysporum followed by 63.12 ± 2.83%, 61.67 ± 3.39% and 55.82 ± 2.76% against Botrytis cinerea, Botryosphaeria dothidea, and Fusarium fujikuroi, respectively. The ethyl acetate fraction revealed a number of bioactive compounds and several were identified as antimicrobial agents such as diketopiperazines, cyclo-peptides, linear peptides, latrunculin A, 5α-hydroxy-6-ketocholesterol, (R)-S-lactoylglutathione, triamterene, rubiadin, moxifloxacin, 9-hydroxy-5Z,7E,11Z,14Z-eicosatetraenoic acid, D-erythro-C18-Sphingosine, citrinin, and 2-arachidonoyllysophosphatidylcholine. The presence of these antimicrobial compounds in the bacterial culture might have contributed to the antifungal activities of the isolated B. velezensis Lle-9. The strain showed plant growth-promoting traits such as production of organic acids, ACC deaminase, indole-3-acetic acid (IAA), siderophores, and nitrogen fixation and phosphate solubilization. IAA production was accelerated with application of exogenous tryptophan concentrations in the medium. Further, the lily plants upon inoculation with Lle-9 exhibited improved vegetative growth, more flowering shoots and longer roots than control plants under greenhouse condition. The isolated B. velezensis strain Lle-9 possessed broad-spectrum antifungal activities and multiple plant growth-promoting traits and thus may play an important role in promoting sustainable agriculture. This strain could be developed and applied in field experiments in order to promote plant growth and control disease pathogens.

Analysis of Factors Influencing the Performance Management of Public Libraries (공공도서관 성과관리에 영향을 미치는 요인 분석)

  • Lee, Mi-Kyeung;Moon, Sung-Been
    • Journal of the Korean Society for information Management
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    • v.29 no.1
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    • pp.303-329
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    • 2012
  • This study measures the efficiency of public libraries, library services, and management to contribute to the proposed model for efficiency analysis, reflecting the characteristics in public libraries. This analysis model of applying the empirical research pursues the solutions to provide efficiency. Although many attempts have been made domestically and internationally to study the measurement of the efficiency, mere application of analysis techniques used in the other public sectors has led to the inadequate measurement for characteristics of library services. In addition, there has not been any attempt made to deduce a general theory for the study from the measurement results. In this study, an analysis model that reflects the inherent characteristics in library services is suggested to be analyzed empirically, and this leads to the understanding of efficiency factors. The results of the study show that the efficiency of current public libraries can be increased on the basis of input and output. Therefore the commitment to increase the level of output to meet the current need shall continue by the amount, rather than by the commitment to reduce the level of input. Finally, the factors influencing the efficiency are the number of users, the physical environment, professional staffs, events planning, and electronic resources. After analyzing the five factors via multiple regression analysis, three factors such as the number of users, professional staff and events planning proved causal relationship with the efficiency.

Comparing Survival Functions with Doubly Interval-Censored Data: An Application to Diabetes Surveyed by Korean Cancer Prevention Study (이중구간중도절단된 생존자료의 생존함수 비교를 위한 검정: 한국인 암 예방연구 중 당뇨병에의 응용)

  • Jee, Sun-Ha;Nam, Chung-Mo;Kim, Jin-Heum
    • The Korean Journal of Applied Statistics
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    • v.22 no.3
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    • pp.595-606
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    • 2009
  • Two tests were introduced for comparing several survival functions with doubly interval-censored data and illustrated with data surveyed by Korean Cancer Prevention Study (Jee et al., 2005). The test which extended Kim et al. (2006)'s test to the doubly interval-censored data has an advantage over Sun (2006)'s test in terms of saving computation time because the proposed test only depends on the size of risk set, and also the proposed test is applicable to continuous failure time data as well as discrete failure time data unlike Sun's test. Comparing male with female groups on the incubation time of diabetes was highly different and the survival of female group was longer than that of male one. Regardless of gender, the difference in survival functions of four age groups was highly significant with p-value of less than 0.001. This trend was more remarkable for female group than for male one. Simulation results showed that the significance level of both tests was well controlled and the proposed test was better than Sun's test in terms of power.

Cabrol Technique Application in Off-pump Coronary Artery Bypass Grafting Using Radial Artery (인공심폐기를 이용하지 않는 관상동맥우회술 시 요골동맥을 이용한 Cabrol 술식의 응용)

  • Na, Chan-Young;Oh, Sam-Se;Kim, Soo-Cheol;Kim, Jae-Hyun;Jo, Won-Min;Seo, Hong-Ju;Lee, Cheul;Chang, Yun-Hee;Kang, Chang-Hyun;Lim, Cheong;Baek, Man-Jong;Whang, Song-Wok;Choi, In-Seok;Kim, Woong-Han;Park, Yoon-Ock;Moon, Hyun-Soo;Park, Young-Kwang;Kim, Chong-Whan
    • Journal of Chest Surgery
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    • v.36 no.8
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    • pp.630-632
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    • 2003
  • In off-pump coronary artery bypass grafting (CABG), multiple proximal anastomosis may increase the risk of cerebral embolism (air, debris) and aortic injury (dissection, pseudoaneurysm). Radial artery (RA) has no intraluminal valve such as saphenous vein. We applied Cabrol technique using aortic root replacement for proximal anastomosis in off-pump CABG. Cabrol technique using RA graft can reduce numbers of proximal anastomosis and reduce number of aortic manipulation in off-pump CABG. We report a Cabrol technique for proximal anastomosis in off-pump CABG with RA graft.

A Route Search of Urban Traffic Network using Fuzzy Non-Additive Control (퍼지 비가법 제어를 이용한 도시 교통망의 경로 탐색)

  • 이상훈;김성환
    • Journal of Korean Society of Transportation
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    • v.21 no.1
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    • pp.103-113
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    • 2003
  • This paper shows alternative route search and preference route search for the traffic route search, and proposes the use of the fuzzy non-additive controller by the application of AHP(analytic hierarchy process). It is different from classical route search and notices thinking method of human. Appraisal element, weight of route is extracted from basic of the opinion gathering for the driving expert and example of route model was used for the finding of practice utility. Model evaluation was performed attribute membership function making of estimate element, estimate value setting, weight define by the AHP, non additive presentation of weight according to $\lambda$-fuzzy measure and Choquet fuzzy integral. Finally, alternative route search was possible to real time traffic route search for the well variable traffic environment, and preference route search showed reflection of traffic route search disposition for the driver individual. This paper has five important meaning. (1)The approach is similar to the driver's route selection decision process. (2)The approach is able to control of route appraisal criteria for the multiple attribute. (3)The approach makes subjective judgement objective by a non additive. (4)The approach shows dynamic route search for the alternative route search. (5)The approach is able to consider characteristics of individual drivers attributed for the preference route search.

Determinants of Success in Ex-parte and Inter-parte Patent Litigation (발명의 특허성 및 특허의 유효성 분쟁결과에 영향을 미치는 요인분석)

  • Choo, Ki-Neung;Oh, Jun-Byoung
    • Journal of Technology Innovation
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    • v.20 no.3
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    • pp.57-91
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    • 2012
  • This paper investigates determinants of litigation success in the two distinctive types of patent litigations, ex-parte and inter-parte cases, which are brought in the process where a filed application becomes a valid patent right. We regress winning rates of patent applicants on the characteristics of firms, trials, patent lawyer, and patent itself, using a probit model with sample selections. The paper finds that the relative suit rate of a firm, time to be sued, changes of patent agents by applicants, and multiple agents among explanatory variables affect ex-parte reexamination and in-parte post-grant patent trials differently in the point of average marginal effects. These variables lower the probability of applicant's victory in the ex-parte cases, while they raise the probability in the inter-parte trials. However, the experience that agents represent applicants is a winning rate-increasing factor both in inter-parte and ex-parte reexamination, unexpectedly. This result cannot be applied to the entire domain of the variable, since sample selection effects are reflected in the result. The number of claim increases the winning probability of the applicant in the both types of patent litigations. This study has some limitations because it ignores the information on the legal person to which a patent agent belongs, and confined agent's experience to patent filing. We leave it future studies to investigate the effects of lawsuit experience of patent agent, and those of characteristics of the law firm to which individual patent lawyer is affiliated.

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