• The Korean Society of Law and Medicine
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• v.22 no.1
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• pp.91-124
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• 2021

In May 2019, the Ministry of Food and Drug Safety revised the "Pharmaceutical Determination and Adjustment Criteria" with the content of differentially calculating the price of generic drugs according to the registration of the drug substance and meeting the requirements for their own bioequivalence test. According to this revised rule, if their own bioequivalence test is not conducted, even the generic drugs that have already been approved would be lowered in price. I wondered whether this system was introduced with sufficient public legal considerations regarding its legislative purposes and means. Therefore, I reviewed the contents of the revised notice based on whether or not it is valid to determine and adjust the price of generic drugs in terms of the legitimacy of legislative purposes and the proportionality principle after introducing the history and background of the rule. First, I raised a question as to whether the purpose of preventing the overrun of generic drugs is indeed legitimate in terms of the legitimacy of the purpose. In order for the revised notice of "reduction of drug prices when the test requirements are not met," to meet the conformity principle, the premise that it is difficult to recognize safety and effectiveness through consignment (joint) bioequivalence test or that these tests are insufficient in safety and efficacy verification than their own test must be established. Nevertheless, it seems that suffficient review has not been carried out. In order to achieve the purpose of securing safety and effectiveness, the focus should be on 'reinforcement of the standards for bioequivalence test and the management of the bioequivalence test itself' rather than whether it is a their own test or a consignment (joint) test. Third, it is contrary to the necessity and substantiality principle that strict standards are uniformly applied to the products that can be considered to have been sufficiently verified for safety and effectiveness after a considerable period of time has passed after the product approval. In many cases, revised administrative legislations quickly enacted and amended in the state of lack of legal review or consensus, while the regulatory effects resulting from it are quite direct and specific to the regulated person. In this respect, I emphasized that the administrative legislative process also requires substantial review and prior control of the regulatory purposes and means, and that the participation of stakeholders in the legislative procedure is to be strengthened.

• Journal of Food Hygiene and Safety
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• v.19 no.4
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• pp.185-192
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• 2004

Generic HACCP models for bakery products may help HACCP implementation at the wholesale bakery production lines easier. When baking, the internal temperature of bakery products went up to $85^{\circ}C$, which resulted in gelatinization of starch. Considering the characteristics of bakery products, general sanitation control procedures are the main target tool to keep bakery products safe. Monitoring of pathogenic microorganisms at bakery plant environment including production lines was carried out. At the wholesale bakery environment pathogenic microorganisms were detected. It gave a clue that general sanitation control procedures should be implemented for safe bakery products supply. Hazard analysis of raw materials and processing of bakery products, and determination of critical control points and critical limits at the wholesale bakeries lead to present generic model of bakery product HACCP plan. CCPs for the wholesale bakery products may be applied and modified for the implementation of HACCP plan at the wholesale bakery plant.

• Journal of KIISE:Computing Practices and Letters
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• v.10 no.2
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• pp.156-173
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• 2004

Business process should support the execution of collaboration process with agility and flexibility through the integration of enterprise inner or outer applications and human resources from the collaborative workflow view. Although the dependency of enterprise activities to the automated system has been increasing, human role is as important as ever. In the workflow modelling this human role is emphasized and the structure to control human error by analysing decision-making itself is needed. Also, through the collaboration of activities agile and effective communication should be constructed, eventually by the combination and coordination of activities to the aimed process the product quality should be improved. This paper classifies human errors can be occurred in collaborative workflow by applying GEMS(Generic Error Modelling System) to control them, and suggests human error control method through hybrid based modelling as well. On this base collaborative workflow modeling tool is designed and implemented. Using this modelling methodology it is possible to workflow modeling could be supported considering human characteristics has a tendency of human error to be controlled.

• Food Science and Biotechnology
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• v.15 no.5
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• pp.651-663
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• 2006

Hazard Analysis and Critical Control Point (HACCP), a systematic process that identifies, assesses, and controls hazards, has been developed as an effective alternative to conventional end-point analysis for food safety control. The importance of HACCP has been emphasized recently due to the development of new food processing technologies and the increase in international trade demanding worldwide of food product safety. This paper provides a review of HACCP and a generic HACCP template for its implementation for aseptic processing of a juice drink.

• Proceedings of the Korean Information Science Society Conference
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• 2004.10b
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• pp.319-321
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• 2004

제품 계열 공학(Product Line Engineering, PLE)는 패밀리 멤버들의 공통성과 가변성을 분석하여 만든 핵심 자산을 특화시켜 어플리케이션을 개발함으로써 재사용성과 이용가능성을 증대시키는 접근 방법이다. 핵심 자산은 제품 계열에 속하는 패밀리 멤버들이 어플리케이션을 만드는데 기초가 되는 모든 자산을 포함하며, 아키텍처, 컴포넌트 둥이 포함될 수 있다. 범용 아키텍처는 패밀리 멤버들이 공통적으로 사용할 수 있는 아키텍처로, 제품 계열에 속하는 제품들의 구조를 정의하고 컴포넌트의 인터페이스 명세를 제공하여 컴포넌트만큼 중요한 재사용 단위이다. 본 논문에서는 대표적인 PLE 방법론에서 정의한 제품 계열 아키텍처와 일반 소프트웨어 아키텍처를 비교하여 범용 아키텍처에 포함되는 요소들을 선정하고, 메타 모델을 이용하여 범용 아키텍처 구성요소와 구성요소간 관계를 명확히 정의함으로써, 개념적인 아키텍처를 보다 실용적으로 설계하는데 도움이 되게 하고자 한다.

• Communications for Statistical Applications and Methods
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• v.5 no.2
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• pp.491-501
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• 1998

Motivated by bioequivalence studies which involve comparisons of pharmaceutically equivalent dosage forms, we propose a more general decision rule for showing equivalence simultaneously between multiple means and a control mean. Namely, this testing procedure is concerned with the situation in that one must make decisions as to the bioequivalence of an original drug product and several generic formulations of that drug. This general test is developed by considering a spherical confidence region, which is a direct extension of the usual t-based confidence interval rule formally approved by the U.S. Food and Drug Administration. We characterize the test by the probability of rejection curves and assess its performance via Monte-Carlo simulation. Since the manufacturer's main concern is the proper choice of sample sizes, we provide optimal sample sizes from the Monte-Carlo simulation results. We also consider an application of the generalized equivalence test to a repeated measures design.

• Natural Product Sciences
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• v.25 no.4
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• pp.293-297
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• 2019

Policosanol extracted from sugarcane wax is a generic term used for total fatty alcohols obtained from esterification of fatty acids. It has been approved as a health functional food by the Ministry of Food and Drug Safety of Korea in 2006. Policosanol is well-known to aid in lowering blood cholesterol level. Recently, several studies have reported the physiological activities of policosanol, such as anti-inflammatory effects, antioxidant effects, and lowering of the incidence of ageing-related diseases, for example, hypertension, stroke, among others. This review describes the physiological activities of policosanol and its applications in the field of health functional foods.

• Proceedings of the Korean Institute of IIIuminating and Electrical Installation Engineers Conference
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• 2008.05a
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• pp.222-224
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• 2008

BLUs(Backlight Units) are major component in LCD(Liquid Crystal Display) industry which occupies 90% or more of worldwide FPD(Flat Panel Display) market. And BLU market is expected to be expanded continuously according to the trend of miniaturization, slimness, low power consumption and low weight. The larger the BLU market scale, the more important standardization of performance evaluation techniques to clearly prescribe the product specification. This document is a generic specification of measurement methods of LED BLU for LCDs. It defines general procedures for quality assessment and gives general rules for measuring methods of LED BLU for LCDs.

• Journal of Distribution Research
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• v.9 no.1
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• pp.1-24
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• 2004

As the dot-com companies realize the importance of the traditional business operations such as product distribution and sourcing, the task of balancing business strategy and operations between electronic commerce and"bricks St mortar"channels is an ongoing challenge. However, there are no generic recipes for formulating business strategy that optimally bridges the physical and virtual operations. In order to provide some guidelines, this study examines the big 3 retailers in Korea, and their"clicks ＆ mortar"strategy, assessing how the activities of each channel are integrated to achieve the synergy effect. This study analyzes the differences in the pattern of integration among the three retailers and traces the causes of those differences. It also figures out the relationship between the degree of integration and performance variables such as growth and cost. Finally. it defines the essential constraints on the process of integration along with managerial implications.

• Advances in aircraft and spacecraft science
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• v.8 no.4
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• pp.331-344
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• 2021

Airframe internal and external specifications are the product of intensive intellectual efforts and technological breakthroughs distinguishing each aircraft manufacturer. Therefore, geometrical information characterizing aircraft primary aerodynamic surfaces remain classified. When attempting to model real aircraft, many members of the aeronautical community depend on their personal expertise and generic design principles to bypass the confidentiality obstacles and sketch real aircraft airfoils, which therefore vary for the same aircraft due to the different designers' initial assumptions. This paper presents a photogrammetric shape prediction method for deriving geometrical properties of real aircraft airframe by utilizing their publicly accessible static and dynamic visual content. The method is based on extracting the visually distinguishable curves at the fairing regions between aerodynamic surfaces and fuselage. Two case studies on B-29 and B-737 are presented showing how to approximate the sectional coordinates of their wing inboard airfoils and proving the good agreement between the geometrical and aerodynamic properties of the replicated airfoils to their original versions. Therefore, the paper provides a systematic reverse engineering approach that will enhance aircraft conceptual design and flight performance optimization studies.