• Title/Summary/Keyword: label quality

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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.

Administration of Yijung-tang, Pyeongwi-san, and Shihosogan-tang for Standardization of Korean Medicine Pattern Identification for Functional Dyspepsia: A Study Protocol of a Randomized, Assessor-blind, 3-Arm, Parallel, Open-label, Multicenter Clinical Trial (기능성 소화불량 한의 변증 표준화를 위한 이중탕, 평위산 및 시호소간탕 투여 : 무작위 배정, 평가자 눈가림, 3군 비교, 평행 설계, 공개, 다기관 임상시험 프로토콜)

  • Boram Lee;Min-Jin Cho;Young-Eun Choi;Ojin Kwon;Mi Young Lim;Seok-Jae Ko;So-yeon Kim;Yongjoo Kim;Donghyun Nam;Dong-Jun Choi;Jun-Hwan Lee;Jae-Woo Park;Hojun Kim
    • The Journal of Internal Korean Medicine
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    • v.43 no.6
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    • pp.1105-1121
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    • 2022
  • Objectives: The purpose of this study is to explore the effectiveness and safety of frequently used clinical herbal medicines (Yijung-tang [Lizhong-tang, LJT], Pyeongwi-san [Pingwei-san, PWS], and Shihosogan-tang [Chaihu Shugan-tang, SST]) in patients with functional dyspepsia (FD) when administered according to herbal medicine and Korean medicine pattern identification. The results of this study will be used to standardize the diagnostic instrument used in Korean medicine and to investigate biomarkers of Korean medicine pattern identification. Methods: This study will be a randomized, assessor-blind, 3-arm, parallel, open-label, multi-center clinical trial. A total of 300 FD participants will be recruited from 3 Korean medical hospitals and assigned to the LJT (n=100), PWS (n=100), and SST (n=100) groups according to FD pattern identification. The patients will take the medication for 8 weeks, 3 times a day, before or between meals. The primary outcome will be total dyspepsia symptom (TDS) and the secondary outcomes will be adequate relief (AR) for dyspepsia, overall treatment effect (OTE), visual analogue scale (VAS), functional dyspepsia-related quality of life (FD-QoL), gastrointestinal symptom score (GIS), and pattern identification questionnaires. For the exploratory outcomes, we will analyze blood and fecal metabolome profiles, microbiota from fecal and saliva samples, single nucleotide polymorphism (SNP), and results of Korean medicine diagnosis device measurements (heart rate variability, and tongue, pulse, and abdominal diagnosis). Conclusions: The results of this study will prove objectivity for Korean medicine pattern identifications, and the effectiveness and safety of herbal medicines for the population with FD.

Study on Developing Assessment Guideline for Safety and Performance of Electric Cupping Apparatus (전동식 부항기에 대한 안전성 및 성능평가 가이드라인 개발연구)

  • Yi, Seung-Ho;Kim, Eun-Jung;Shin, Kyung-Hoon;Nam, Dong-Woo;Kang, Jung-Won;Lee, Seung-Deok;Lee, Hye-Jung;Lee, Jae-Dong;Kim, Kap-Sung
    • Journal of Acupuncture Research
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    • v.26 no.6
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    • pp.101-110
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    • 2009
  • Objectives : We developed and proposed a guideline for safety and performance assessment of electric cupping apparatus(Class 2 medical device). Methods : We drafted the guideline for safety and performance assessment of electric cupping apparatus by referring the existing standards and guideline, based on online questionnaire for Korean medical doctors and measurement data from commercially available products. Physical dimension of cups and inner vacuum pressure were acquired for the measurement in order to achieve the purposes. Results : This guideline only can be applied to electric cupping apparatus for enhancing blood circulation by employing negative pressure generated by electricity. Seven items of appearance and label, operation test of pump, variation test of input electricity, vacuum level test, vacuum sustain test, cup-size dependent test, noise level test are suggested for evaluation subjects and methods required for electric cupping devices. Requirements for the design and development of electric cupping devices are suggested: vacuum level indicator, vacuum generation rate, pressure control, valve detachment stability, cup comparability, safety measure, surge protection, user friendliness, instruction for use (IFU). Conclusions : We proposed a guideline for safety and performance assessment of electric cupping apparatus to improve the quality of relating products and aid the commercialization of them, by aiming higher industrial competitiveness of the medical device sectors in Korea. Discussion with related institutes such as industry, academy and government is further required. Public hearings also need to be held prior to the establishment of a final guideline and standard.

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A Survey on Nurses' Utilization of Computerization in Nursing Practice (간호사의 간호업무 전산화 활용에 대한 조사연구)

  • Rhee, In-Soon
    • Journal of Korean Academy of Nursing Administration
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    • v.5 no.2
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    • pp.209-224
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    • 1999
  • I have practiced this reserch for the purpose of proposition of basic data for amendment and addition of computer system after I surveyed the degree of abilities and satisfaction on the computerization in nursing\ practice. Subjects were collected from September 1 to September 30, 1998. Study subjects are 151 clinical nurses who are working at university hospital in Chonbuk area. Study instrument consists of 116 questionnaire which was developed by Kim H. K(1998). The data were analized number, mean ,t-test, ANOVA by using SPSS. The study results are as follows: 1. Most of the nurses who answered the questions were educated computerizing(96%). The abilities of computer program utilities were the most in inputting data(74%). The program nurses wanted computerizing education was wordprocess, dealing internet and statistics. 2. As for applying parts of computer system in nursing, the most nurses were Dr's order check (96%), treatment activity(91.4%), medication(89.4%), lab. test(87 .4%), transfering department(85.4%), transfering room(79.5%), diet(71.8%), discharge (70.2%), Barcord Sticker(70.2%) , reservation(62.2%) in order that were all conected order system mutually to other part. It showed that computer system was not applied for treating the original nursing work such as nursing record (13%), duty scheduling(6.0%) , nursing process(4.6%) , Q.I(1.3%), nursing research(1.3%), education(1.3%), 3. As for the benefit when computer system is applied for, the most respondence was promptness of work and convenience(90.6%) , exactness of work (82.8%), offering information exactily and efficiently(36.3%), offering good quality of nursing (6.0%) in order. 4. The degree of contentment on computerizing in nursing practice showed average 3.24%. The best marking item is that they are eager to participate in the computer education. Next, the automatic output of label and giving the number automatically is to prevent loss and mentioned items of patient registration from being changed(3.95) and to prevent mistakes possibly happening because of doctor's difficult order(3.85). 5. The problems which may happen to in nurses' utilization of computerization for the nursing practice showed average 3.18. The most problem is that the practice may stop because of the problem of computer itself(3.67), and the next, the indication of act can be imperfect(3.66) , manual training may overlap because of incomplete computerization (3.60), practical education for the computerizing is lack(3.41), and the computer literate nurses are lack(3.40) . 6. Study subject's contentment by age was significant difference(F=3.10,P=0.0119). Study subject's contentment by job posision was significant difference(F=6.001P=0.0034) I will propose the following according to the above results. The domain of original nursing practice is urgernt. Manual and indication of act should be made before long in computer obstacle. Nursing department should support the nurses so that they could receive the education needed for the nurses themselves.

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An Analysis of Consumer's Taste on Environment-Friendly Agricultural Products in Korea (우리나라 친환경 농산물에 대한 소비자 의향분석)

  • 이종성;오주성;손흥대;양원진;정원복;정순재;김도훈
    • Journal of Life Science
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    • v.12 no.4
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    • pp.433-441
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    • 2002
  • There has been an increasing public concern about environmental safety and human health of field crops while customer consumes more and more field crops, to which overdose and residual chemicals were applied. As a solution for the problems, construction of sustainable agroecosystem is spreading out to pursuit the economic value of agricultural management as well as to meet environment concern. Public has extended their understanding on the preservation of environment and safeness of agricultural products, and governmental policy toward sustainable agriculture drives rapid increase of the production of sustainable agricultural products. Under this circumstances, it is time to encourage more consumption and to activate market system for the sustainable agricultural products. This study was initiated to diagnose the problems and future direction of domestic sustainable agriculture by analyzing the overall opinions of consumer on the sustainable agriculture. The results are as follows: The pursuit of low input management is a prerequisite to creat high valued agricultural products, and serious consideration should be taken to produce clean crops using natural products. Consummers are willing to pay 10∼50% more prices if the products get certified by official eco-label programs. It is believed that practice of sustainable agriculture using biopesticide and natural pesticide would accelerate the rapid extension of this pro-environmental agricultural management. To activate production and consumption of sustainable agricultural products correct informations on safety should be addressed to customer, and confidence has to be brought about from customer. This could be done by obtaining various and efficient distribution route, product competency for quality, upgraded sales strategy, maximum utilization of certificate system, and practice of recall system, so on.

Effective Components of Commercial Enzyme Food Products and Their HACCP Scheme (시판 효소식품의 유용성분과 HACCP 관리 방안에 관한 연구)

  • Lee, Eun-Joo;Lee, Cherl-Ho
    • Korean Journal of Food Science and Technology
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    • v.33 no.4
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    • pp.461-468
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    • 2001
  • The effectiveness and safety of Enzyme Food, a group of dietary supplements designated by Korean Food Law, were evaluated and the possibility of HACCP (Hazard Analysis Critical Control Point) application was investigated. Chemical composition, enzyme activities and the degree of bacterial contamination in 12 samples of different brands sold in Korean market were measured. The chemical composition of the selected products varied and inconsistent to those claimed in the label description. It is known that effectiveness of Enzyme Food depends on enzyme activity, but enzyme activities of ${\alpha}-amylase$ varied from $1,793\;{\mu}g/min$ g to $159\;{\mu}g/min$ g and those of ${\beta}-amylase$ ranged from $171\;{\mu}g/min$ g to $11\;{\mu}g/min$ g. The protease activities varied from $27.57\;{\mu}g/min$ g to $0.18\;{\mu}g/min$ g. In coli-form bacterial test, positive reactions were appeared in the 50 % of the samples. Numbers of bacteria ranged from $1.3\;{\times}\;10^5\;to\;1.2\;{\times}\;10^9$. Five CCPs were identified; heating, inoculation, cultivation, drying and granulation. Consideration of HACCP system indicated that the pretreatment of raw material, checking of bacterial contamination and stability of enzyme activity during fermentation process were important factors for the quality of Enzyme Foods.

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Automatic Training Corpus Generation Method of Named Entity Recognition Using Knowledge-Bases (개체명 인식 코퍼스 생성을 위한 지식베이스 활용 기법)

  • Park, Youngmin;Kim, Yejin;Kang, Sangwoo;Seo, Jungyun
    • Korean Journal of Cognitive Science
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    • v.27 no.1
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    • pp.27-41
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    • 2016
  • Named entity recognition is to classify elements in text into predefined categories and used for various departments which receives natural language inputs. In this paper, we propose a method which can generate named entity training corpus automatically using knowledge bases. We apply two different methods to generate corpus depending on the knowledge bases. One of the methods attaches named entity labels to text data using Wikipedia. The other method crawls data from web and labels named entities to web text data using Freebase. We conduct two experiments to evaluate corpus quality and our proposed method for generating Named entity recognition corpus automatically. We extract sentences randomly from two corpus which called Wikipedia corpus and Web corpus then label them to validate both automatic labeled corpus. We also show the performance of named entity recognizer trained by corpus generated in our proposed method. The result shows that our proposed method adapts well with new corpus which reflects diverse sentence structures and the newest entities.

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Commercialization of Field for Improving VI Design & Package Design at Rural Tourism Village and Its Effect : Focused on Ok-Gye Village of Youngcheon (농촌관광마을 VI디자인·포장디자인 개선 현장 실용화 및 효과 - 연천옥계마을을 중심으로 -)

  • Jin, Hye-Ryeon;Chae, Hye-Sung;Jo, Lok-Hwan
    • Journal of Korean Society of Rural Planning
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    • v.20 no.3
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    • pp.191-199
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    • 2014
  • The current rural conditions are undergoing the change from the past production-intensive structure to an integral and complex one of producing, processing, selling, touring and lodging owing to the changes of life-style, consumption trend and social environments. The rural area is developing into a community of rural tourism villages to grow into one management system along with the assistance of the government's various supporting projects. Through this, the rural designing has got to play a significant role as one of the factors of the enhancement of competitiveness and the increase of income. Therefore, those previous studies on the variety and possibility of rural development are being employed for the researches which are to develop techniques of branding, marketing and packaging. In particular, the researches for VI (Village Identity), BI (Brand Identity) and designs of landscaping, packaging of agricultural specialties and display stores, which definitely shows that the importance of rural designing, is being paid a lot more attention to. Thus, this study has verified the site commercialization and its effect by developing some practical designing with the focus of package design at rural tourism villages. The Okgye Village in Yoncheon was selected for study subject based on the result of status investigation. This study has analyzed such problems as lack of village identity, non-description of items and their indispensible marks which were seen their designs of village and packaging. The colors of major items and the village image being substituted into the image scale of IRI color were estimated so that the appropriate colors might be selected, along with which the shapes of major items were decided to be motif for the village symbol and design to be created. The designs of such major items as grains, greens and sauces were created with the consideration of the easiness of loading, the continuity of using and the aesthetics. For grains, those outer boxes which are possible for set-packaging and small-sized packaging have been developed. For greens were developed the boxes with the structure of the permeability for the persisten't quality as well as the possibility for packaging small amount. In case of sauces, those outer-boxes equipped with fixing tray were made with the transport-convenience taken into consideration. The sticker-label designs for all those three were also developed which stand for the village identity and are conveniently used in each farm family. When this development was applied at the sites, it was found that the satisfaction and reliability of consumers as well as the satisfaction of farmers were raised along with the increase by more than 30% after the improvement.

Performance Evaluation of PCR Kits for Detecting Genetically Modified Crop Ingredients (유전자 변형 작물 성분 검출용 PCR Kit의 성능 평가 연구)

  • 윤시온;정순천;윤원기;박상규;문제선;이정현;김환묵
    • Toxicological Research
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    • v.20 no.2
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    • pp.101-108
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    • 2004
  • The different social reflections about the benefits and the potential risks of genetically modified (GM) crops have evolved with .different reactions in different countries. Many countries including Korea are working toward setting down new guidelines. Korea requires companies to label all food that contains more than 3% GM ingredients. One of the rapid and convenient detection methods of GM ingredients is amplification of the introduced DNAs by polymerase chain reaction (PCR). Many PCR kits for this purpose are commercially available. The objective of this study was to evaluate performance of commercialized GM crop detection kits. The results showed that 6 out of 15 kits tested did not meet the requirements even purposed by the manufacturers themselves in terms of stability, reproducibility, and detection limits, suggesting a potential quality control problem in their design stage or production line. The evaluation also suggests that, although the duplex and triplex detection kits allowed unambiguous detection in a single PCR reaction, the monoplex detection kits were the most sensitive to the detection of GM ingredients. The detection limits also differ between soybean and corn. Results from this study will be useful in the development of sound qualitative tracking systems of GM ingredients for monitoring throughout the cultivation of GM crops, their trans-boundary movement, and food production using GM grains as well as for complying with government guidelines associated with GM crops.

A Study on Classification of Fish Oil Types and Its Usage by 13C-NMR Spectra and Fatty Acids Analysis (13C NMR 분석 및 지방산 분석을 통한 어유의 종류 구분 및 사용 실태에 관한 연구)

  • Cho, Eun-Ah;Lim, Sung-Jun;Oh, Tae-Heon;Ahn, Hyun-Joo;Yuk, Soo-Jin;Choi, Jin-Uk;Cha, Yun-Hwan;Lee, Young-Sang
    • The Korean Journal of Food And Nutrition
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    • v.26 no.3
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    • pp.352-357
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    • 2013
  • This study estimates the classification criteria which distinguishes the types of omega-3 health functional foods, fish oils and fish oil usages through $^{13}C$-NMR spectra and fatty acids contents analysis. The major fatty acids of omega-3, eicosapentaenoic acid (EPA, $C_{20:5}$) and docosahexaenoic acid (DHA, $C_{22:6}$) are being analyzed. 10 ethyl ester (EE) forms and 10 triglyceride (TG) forms are the most common types of fish oils for 20 omega-3 products. Gas chromatography (GC) analysis generally shows the matching EPA and DHA contents of the products listed on the notation. But EE form contents of EPA and DHA are higher and are more varied than the TG form. Most of the samples of EPA/DHA ratio show different content ratios of indicated on the products when comparing with standards. The $^{13}C$-NMR analysis of EPA and DHA on sn-1,3 and sn-2 carbonyl peak position with fish oil triglycerides display whether the reconstituted triglycerides (rTG) are being confirmed or not. As a result of the 9 TG form, the 10 TG products showed similar values: EPA sn-1, 3; 13.46~15.66, sn-2; 3.00~4.52, DHA sn-1, 3; 2.43~4.40, sn-2; 3.84~6.36. But one product showed lower contents (EPA: sn-1, 3; 5.88, sn-2; 2.86, DHA sn-1, 3; 2.29, sn-2; 5.95) of EPA, thus it can be considered a different type of oil and only matched six products according to the label. This study is intended to provide basic materials which identify the status for the types and quality of omega-3 fish oil products according to fatty acids profiles and the $^{13}C$-NMR spectrum confirmed the location specificity of EPA and DHA.