• 약학회지
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• 제58권2호
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• pp.112-124
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• 2014

This study aimed to develop a regulation system for off-label drug use to secure the safe use of marketed drugs. We searched governmental documents for national and global regulating systems of off-label drug uses and a body of academic literature to explore current regulating trends. We included European Union, United Kingdom, United States of America, Australia and Japan, and critically reviewed the regulation of off-label drug use in four issues, which were a regulatory structure, safety control before and after off-label use, and information management. The findings of the present investigation called for several measures in off-label drug uses: enhancing prescribers' self-regulation, providing up-to-date information to prescribers for evidence-based practice and to patients for their informed consent, making evidence with scientific rigor, building an official registering process for off-label use in good quality and extending the role of pharmaceutical industry in pharmacovigilance. At last, we proposed a new system so as to regulate and evaluate off-label drug uses both at national and institutional level. In the new system, we suggested a clear-cut definition for clinical evidence that applicants would submit. We newly introduced an official 'Off-Label Drug Use Report' to evaluate the safety and clinical efficacy of a given off-label drug use. In addition, we developed an algorism of the regulation of off-label drug use within an institution to help set up the culture of evidence-based practices in off-label drug uses.

• Journal of Pharmaceutical Investigation
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• 제10권3호
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• pp.51-77
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• 1980

A comparison of worldwide drug registration requirements on scientific data required by the different regulatory authorities for the investigational new drug and new drug application for human uses was briefly reviewed and as one of administrative processings on review and evaluation of applications, the functions of scientific advisory committees were reviewed.

• 한국전자통신학회논문지
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• 제8권6호
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• pp.963-969
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• 2013

본 연구는 제5차 청소년건강행태 온라인조사 자료를 통해 중고생의 인구학적 특성, 건강, 인터넷 중독 요인에 따른 약물사용의 차이를 비교하고자, 첫째, 각 변인에 대한 빈도분석, 백분율, 평균 등의 기술 통계분석을 진행하였으며, 둘째, 각 독립변인에 따른 약물사용 여부의 차이를 고찰하고자 카이자승 검증을 진행하였다. 연구결과를 정리하면, 인구학적 특성 요인에 있어서는 남학생이 여학생보다, 부모와 동거하지 않는 경우에, 가계의 경제수준이 높은 경우에, 중학생의 경우에, 성적이 낮은 경우에, 건강 요인에서는 주관적으로 건강하지 못하다고 느끼는 경우에, 주관적으로 행복하지 못하다고 느끼는 경우에, 스트레스정도가 낮은 경우에, 우울을 경험한 경우에, 그리고 인터넷 중독 요인에 있어서는 인터넷 중독인 경우에 그렇지 않은 경우에 비해 통계학적으로 유의한 수준에서 높은 약물사용 빈도를 보이는 것으로 나타났다. 이상의 결과를 토대로 본 연구에서는 중고생의 약물 사용에 대한 예방과 대책에 대해 논의를 진행하였다.

• 한국식품위생안전성학회지
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• 제35권3호
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• pp.252-260
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• 2020

본 연구는 특수용도식품에 함유되어 있는 비타민B₁₂와 비오틴에 대하여 식품의 복잡한 매질 특성에 특이성을 확보할 수 있도록 현행 식품공전 시험법을 개선하고자 하였다. 식품공전에서 비타민B₁₂와 비오틴의 시험법에 항체반응을 통해서 분석물질과 특이적으로 결합하여 그 외의 성분들을 효과적으로 제거할 수 있는 면역친화성 컬럼을 도입하여 시험용액을 정제 및 농축함으로써 전처리 과정을 개선하였다. 식품 등 시험법 마련 표준절차에 관한 가이드라인에 따라 밸리데이션(특이성, 직선성, 검출한계, 정량한계, 정확도, 정밀도)을 수행하고 개선된 시험법을 이용하여 유통 중인 특수용도식품의 대상 품목에 대해 시험법 적용여부를 확인하였다. 본 연구사업의 수행으로 시험·검사의 정확성을 증대시켜 특수용도식품 품질관리에 대한 신뢰성을 더 높일 것으로 본다.

• 한국간호교육학회지
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• 제6권2호
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• pp.376-389
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• 2000

The Purpose of this study was to grasp the status of drug uses in college students, and to investigate the knowledge and attitude when they use it. We collected through questionnaires from Sep. 1 to Oct. 30 in 1999. The subjects were 490 college students in Seoul and northern of the Kyunggi-do. The data analysis was performed using SPSS (version 7.0) and ANOVA. The results of this study were as follows. 1. There was no correlation for all factors in the relationship between general characteristics of subjects and knowledge for drugs. On the contrary, in the relation of the general characteristics and attitude for drug of subjects, some factors are statistically significant e.g., department (F=3.049, p<.010), satisfaction for school life (F=6.167,p<.002), body shape(F=8.092, p<.000), and the relationship with ones parents (F=3.728, p<.005). 2. In the analysis of drug use status and knowledge, only in the factor of administration control was statistically significant(F=4.304, p<.014) and in the relation of attitude for drug uses, drug administration was statistically significant (F=4.521, p<.004). 3. In the mean scores for the drug knowledge analysis, the highest factor was 'A narcotic make deformed persons through poisoning of physical and mental' (M=4.14), the lowest factor was 'If catch the flu during the pregnancy, should be take drug as possible as quickly to reduce negative effect for fetal' (M=1.94). 4. In the analysis for drug attitude, the highest factor was 'A drug is alike a poison' (M=3.48), 'Should be keep the usage and dosage of drug' was the lowest (M=1.48). 5. From the investigation for status of drug use, it was revealed that the most subjects (73.6%) were purchase drugs after explain their symptoms to pharmacist. And they take drugs only when they felt painful in 43.1%. The most students (70.4%) were experienced control of drug administration. It was inquired that subjects were mainly obtained information about drugs from pharmacist and television (or radio) advertisement, 33.5% and 33.1%, respectively. In the examination for existence of long-term administrators in their family, 'none' and 'only parents' are 49.6% and 37.3%, respectively. When their parents have illness, the persons go to drugstore and hospital for heath-care, 47.8% and 44.3%, respectively. On the basis of results of this study, we suggest as follows. 1. This study was analyzed data from questionnaires for college students in a part of local areas, so we suggest that the next research should be perform for national-wide students as subjects to generalize the results. 2. It is need more intensive research methodologies such as interview and observation. 3. Additional research is required for knowledge and behaviors of drug uses that will how impact on ones health behavior.

• 대한간호학회지
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• 제30권1호
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• pp.7-17
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• 2000

The purpose of this study is to affect health improvement of adolescent, to understand behavioral causes follow adolescent's drug abuse, to understand recovery and rehabilitaton process of adolescent drug abuser. The data are collected through open questionnaire and interview of 25 adolescents from the experienced drug abuse 16 students(male 8, female 8) in two vocational high schools and admissing adolescents 9 person in Alcohol-Drug Addiction Care Centre in Seoul from June 28th to August 31st, 1994. The collected data are arranged and explained through categorizing method stated contents about motives, causes, experiences and effected behaviors for using the drugs of drug abuser adolescents. DRUG USING MOTIVATION They are almost first son and daughter in their family. In their conversation person, male converses to their mother well, but female does not converse to their parents include family. Both groups respond positively to companionship and attitude to other, but negatively to self-confidence and actualizing attitude. They hope always peace of family and want to do their best for their life. In school group, hard and difficult things are school life and family problems, also using the drugs for resolving the them. About drug using behaviors, male responds to bad habbit and shamfull, but female is unconcerned with drug using attitude. The first background of drug using, male gets to use because of curiosity and to be induced from friends or seniors, but female gets to use for feminine beauty(thin body) and escape from reality. Used the drugs, male uses frequently Bond, Butane-Gas among inhalation materials and also marijuana, but female uses various diuretics. The times of drug using, both groups repond to use during the chaging of emotion or filling with stress. The place of drug using, both groups take drugs in vacant houses or in the mountain. The frequency of drug using, they use almost once in a day and they use mostly alone or drug user in friends. Experienced mental changing after drug using, which is fantasy, ecstasy, anxiety and suicidal feeling, and experienced physical changing after drug using, which is elevating sense, headach, abdominal pain, dyspnea and chaging of skin colour and reddish. They coincide with inconvenience feeling due to drug using. RECOVERY AND REHABILITATION PROCESS OF DRUG USING ADOLESCENTS The reason for reforming drug using behavior and attitude, both groups respond to reforming for oneself and social life. The difficult things during the stop to using drugs, all of them responed to family problems, friends problems and temptation and impulse. As for stop to using drug, they need good advise, understandable attitude and family love. But they do not need to be stigmatized, scolding, over protect and ridicule of friends. Also they entreat continuous understanding, advise, concern and the method for resolving stress. For the friends to want to use the drug, they will talk about the stories of their personal experiences and for the friends to stop to using the drug, they will consider for them how to stop. From the theses results, drug users understand personal problems due to drug using, and consider about why to stop and how to stop. Also drug users need to resolve the family problems, personal problems, stress and temptations or impulses. Accordingly this paper suggests that drug users in adolescents need understandable and acceptable atitudes, loving and tenderness, continuous advice and concern, and hopes for life.

• 대한약학회:학술대회논문집
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• 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-2
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• pp.227.2-228
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• 2003

In many biodegradable polymers recently investigated, poly(lactic acid)(PLA) or poly(lactic-co-glycolic acid)(PLGA) have extensively been utilized as drug delivery systems for sustained release drug delivery. Recently, there has been increased interest in electrospinning, which can produce fibers that are sub-micron in diameter. This technique has been applied to various micro/nano fabrication areas using numerous polymers but very few uses in the sharmaceutical area have been reported. (omitted)

• 한국컴퓨터정보학회논문지
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• 제21권1호
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• pp.115-123
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• 2016

In this study, we collect various side effect pairs which are appeared frequently at many drugs, and select side effect pairs that have higher severity. For every selected side effect pair, we extract common genetic networks which are shared by side effects' genes and drugs' target genes based on PPI(Protein-Protein Interaction) network. For this work, firstly, we gather drug related data, side effect data and PPI data. Secondly, for extracting common genetic network, we find shortest paths between drug target genes and side effect genes based on PPI network, and integrate these shortest paths. Thirdly, we develop a classification model which uses this common genetic network as a classifier. We calculate similarity score between the common genetic network and genetic network of a drug for classifying the drug. Lastly, we validate our classification model by means of AUC(Area Under the Curve) value.

• Journal of Pharmaceutical Investigation
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• 제35권1호
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• pp.57-63
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• 2005

Numerous drugs are chiral because they possess one or more chiral centers. Enantiomers may differ in their pharmacokinetic, pharmacological and toxicological properties. However, the significance of stereochemistry of drugs in their therapeutic uses has received relatively little attention until recently. The US FDA issued a guideline on stereoisomeric drugs in 1992, and the European agency describes tests for new drug substances which are optically active in an ICH(International Conference of Harmonization) guideline. According to the guidance, enantiomers may differ in their pharmacokinetic, pharmacological and toxicological properties. Therefore, in this paper, we examined the recently published Canadian guidance, stereochemical issues in chiral drug development, which will be references to make a guidance on stereochemical issues in chiral drug development in Korea.

• 한국생산제조학회지
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• 제26권1호
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• pp.36-43
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• 2017

A drug infuser is a well-known device that is widely used in various areas of clinical practice. However, some materials used in the drug infuser have been developed for particular purposes and thus, their design characteristics have to be changed considerably. Especially, the implications of a new filler in the drug infuser have migrated to the areas of body corrections in plastic surgery. In this study, the design process of a drug infuser managing a large content volume has been studied from the perspective of structure safety. A new design of the drug infuser that uses a 10 cc filler with high viscosity is presented. Finite element analysis is used to confirm that the assembled drug infuser is safe enough to hold the required loading of 490 N. Furthermore, the final prototype of the drug infuser was successful in reducing the weight up to 400 g without compromising the safety.