• Proceedings of the Korea Contents Association Conference
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• 2007.11a
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• pp.799-803
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• 2007

In this paper, we research into an effective operation environment of digital textbook according to the adaption of an electronic textbook and analyze the approval program and the authorization program of the paper textbook for the efficient utility of a digital textbook. We propose various criterions and methods of the approval and authorization program. Finally, we show the whole process of the proposed approval and authorization program. We hope that our study apply to the standard approval and authorization program of the Ministry of Education.

• Journal of Digital Convergence
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• v.11 no.9
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• pp.357-363
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• 2013

This study aims to establish and apply a mobile office app for approving the achievements of tasks assigned to each person to investigate resulting satisfaction. This is done first by implementing the app for approval in a company with smart phones to enable tasks to be carried out any time and anywhere while the mobile office environment changes the method of carrying out tasks. More efficient work environment is expected if the system implemented in this study is improved in cooperation with customer's requirements. Matters for improving work efficiency added to the approval management system through this app will contribute to efficiently and continuously improving the mobile office environment to enhance productivity and efficiency of a company.

• Journal of the Korea Institute of Military Science and Technology
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• v.19 no.1
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• pp.119-126
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• 2016

The US Army used MARK-1 composed of atropine autoinjector and 2-PAM autoinjector as a medical countermeasure against nerve agent poisoning. Recently, it has been being replaced by the ATNAA(Antidote Treatment Nerve Agent AutoInjector) for improvement the convenience in use and rapid detoxification effect. ATNAA(FDA approval, NDA 21-175, 2002. 1. 17) is a multi-chambered autoinjector that sequentially delivers atropine and 2-PAM through a single needle to allow Warfighters to survive against lethal exposure to nerve agents. In this paper, our group investigated the case of FDA approval of ATNAA in a point of the various data required by FDA guideline, thereby making it easy to meet the KFDA guideline for the approval of the prototype our group has been developed. The purpose of this study is to provide a reference for efficient research activities to minimize time and cost. Additionally, the purpose of this study is to provide a reference for the planning for the development of similar drug.

• Translational and Clinical Pharmacology
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• v.26 no.4
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• pp.155-159
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• 2018

For regulatory approval of a new drug, the most preferred and reliable source of evidence would be randomized controlled trials (RCT). However, a great number of drugs, being developed as well as already marketed and being used, usually lack proper indications for children. It is imperative to develop properly evaluated drugs for children. And expanding the use of already approved drugs for other indications will benefit patients and the society. Nevertheless, to get an approval for expansion of indications, most often with off-label experiences, for drugs that have been approved or for the development of pediatric indications, either during or after completing the main drug development, conducting RCTs may not be the only, if not right, way to take. Extrapolation strategies and modelling & simulation for pediatric drug development are paving the road to the better approval scheme. Making the use of data sources other than RCT such as EHR and claims data in ways that improve the efficiency and validity of the results (e.g., randomized pragmatic trial and randomized registry trial) has been the topic of great interest all around the world. Regulatory authorities should adopt new methodologies for regulatory approval processes to adapt to the changes brought by increasing availability of big and real world data utilizing new tools of technological advancement.

• Journal of Distribution Science
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• v.20 no.12
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• pp.23-33
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• 2022

Purpose: The objective of the study is to examine the role of approval goals, subjective norm, internal motivation, external motivation, attitude towards behavior, and perceived behavioral control on retail consumer's intention to consume fortified food in Pakistan. Research design, data, and methodology: The study was quantitative in nature. That is why the data were collected from 384 respondents approaching retail stores of Lahore, Gujranwala, and Faisalabad using mall intercept survey. Partial least squares structural equation modeling (PLS-SEM) was used to analyze the data. Results: The results show that approval goals significantly influence subjective norms. Secondly, subjective norms positively influence internal and external motivation. Thirdly, attitude towards behavior and internal motivation significantly impacted on intention. However, the findings of the study show, non-significant relationship of external motivation and perceived behavioral control with intention to consume fortified food. Conclusion: Theory of reasoned goal pursuit was used to investigate consumer intention to consume fortified food in Pakistan. This study is helpful for the marketers to create a word-of-mouth strategy to enhance positive word of mouth for the company, which ultimately beneficial to develop the distribution strategy of the firm. Fortified food is full of health enriched ingredients which is beneficial for society at large.

• Journal of Biomedical Engineering Research
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• v.43 no.3
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• pp.153-160
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• 2022

As new types of medical devices are emerging through convergence with advanced technology, innovative technologies are becoming hot issues in health policy because of their disruptiveness. This study analyzed the innovative medical device management systems in the US, China and Korea. Innovative medical devices have been defined differently depending on the country's management system, but in common, they are defined as products that do not exist or have dramatically improved performance compare to existing products by applying innovative technologies. Innovative medical devices have been supported by regulatory authorities during product development and approval processes. While the US and China have more than 300 products designated as innovative medical devices with diverse functions, application fields, and manufacturing countries considering the initial situation of the implementation for the system, Korea has only 16 products, mainly radiology and diagnostic devices and made in Korea only as innovative medical device. In addition, Korea shows the highest market approval rate of innovative medical devices compare to the US and China, and it is necessary to prepare the approval process in consideration of product diversity.

• Nuclear Engineering and Technology
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• v.49 no.7
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• pp.1537-1546
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• 2017

Many thermal-hydraulic tests have been conducted at the Korea Atomic Energy Research Institute for verification of the SMART (System-integrated Modular Advanced ReacTor) design, the standard design approval of which was issued by the Korean regulatory body. In this paper, the contributions of these tests to the standard design approval of SMART are discussed. First, an integral effect test facility named VISTA-ITL (Experimental Verification by Integral Simulation of Transients and Accidents-Integral Test Loop) has been utilized to assess the TASS/SMR-S (Transient and Set-point Simulation/Small and Medium) safety analysis code and confirm its conservatism, to support standard design approval, and to construct a database for the SMART design optimization. In addition, many separate effect tests have been performed. The reactor internal flow test has been conducted using the SCOP (SMART COre flow distribution and Pressure drop test) facility to evaluate the reactor internal flow and pressure distributions. An ECC (Emergency Core Coolant) performance test has been carried out using the SWAT (SMART ECC Water Asymmetric Two-phase choking test) facility to evaluate the safety injection performance and to validate the thermal-hydraulic model used in the safety analysis code. The Freon CHF (Critical Heat Flux) test has been performed using the FTHEL (Freon Thermal Hydraulic Experimental Loop) facility to construct a database from the $5{\times}5$ rod bundle Freon CHF tests and to evaluate the DNBR (Departure from Nucleate Boiling Ratio) model in the safety analysis and core design codes. These test results were used for standard design approval of SMART to verify its design bases, design tools, and analysis methodology.

• The Journal of Korean Medical History
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• v.27 no.2
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• pp.11-37
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• 2014

Objectives : The purpose of this study was to analyze and identify the problems of the changes in regulations that are relevant to approval, notification, and review of herbal medicinal preparations and crude drug preparations. Methods : I collected the regulations of approval, notification, and review of medicinal products mostly from official gazettes, analyzed enactment and amendments regarding herbal medicinal preparations and crude drug preparations, and studied it from the view point of Korean medicine field. Results : Regulations in regards to approval, notification, and review of herbal medicinal preparations and crude drug preparations were first established in 1978. Herbal drugs started to be categorized as crude drug preparations in 1981 and the regulatory outlines were completed in 1999. From 2008 to 2012, the regulatory standards that let crude drug preparations be new drugs from natural products were established. Through those procedures, the followings became crude drug preparations: 1) wholly new prescriptions that are not recorded in Korean Medical Classics, 2) prescriptions that are recorded in Korean Medical classics but prepared with new standard, composition and efficacy, 3) prescriptions that are recorded in Korean Medical classics but prepared with new formulation, and 4) herbal drugs. In case of herbal medicinal preparations, however, only regulations that are related to 1) drugs prepared with new compositions that are not recorded in Korean Medical Classics, 2) drugs with same prescription and same formulation, and 3) drugs with new formulation were arranged. Conclusions : Actual circumstances on crude drug-oriented regulations regarding approval, notification and review and future forms of prescription and drug administration in Korean Medical Institutions can be expected due to expansion in range of herbal medicinal preparations and shrink in that of on-site preparations. Reasonable improvement in efficient usage of modernized herbal medicinal preparations in Korean medical institutions and prospective cooperation from related pharmaceutical industry are needed.

• The Journal of the Korea Contents Association
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• v.13 no.8
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• pp.171-179
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• 2013

During 19th general election the customized LBSNS(Location Based SNS) application for some candidates of the National Assembly planned and developed based on the object identification, ePosition, comprising the candidate's name have been applied for an election campaign. The approval rating change before and after 19th election campaign period for each candidate was quantitatively studied how it would be affected by the candidate custom LBSNS application. Only 3 out of 24 candidates in 6 local electorates in the Daejon Metropolitan City have adopted the customized LBSNS application and the rest 21 candidates have not, whose approval rating change before and after an election campaign has been analyzed comparatively candidate by candidate. The approval rating for 3 candidates adopting LBSNS application went up by 12.6%, 11.4%, 11.2% respectively, but those for the rest 21 candidates all changed within 3%.

• Korean Journal of Health Education and Promotion
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• v.27 no.4
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• pp.113-121
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• 2010

Objectives: The study sought to identify the perception of schoolchildren's parents concerning an approval on the expansion implementation of community water fluoridation program in Gimhae, Korea. Methods: Questionnaires were distributed to schoolchildren's parents in Gimhae in 2008. Responses were collected from 1,703 parents. The standard questionnaire of Ministry of Health and Welfare was used and items were socioeconomic variables, water used for drinking and cooking, awareness on the fluoridation program and approval on the expansion implementation of fluoridation program at the region of Myeongdong water plant. Significance was analyzed by chi-square test and multiple logistic analysis. Results: Of parents, 1.9% used plain tap water and 39.8% used boiled tap water for drinking and 50.0% used tap water for cooking. 58.0% of parents were aware of fluoridation program with 27.1% being aware of the implementation of the program in Gimhae. 74.5% approved the expansion implementation of the program to the region of Myeong-dong water plant. Significant variables associated to approving the expansion implementation of program were age, gender, residence period in Gimhae, occupation and awareness of the program. Conclusion: The expansion implementation of fluoridation program in Gimhae is desirable for caries prevention because of the majority of schoolchildren's parents' approval.