• 제목/요약/키워드: drug supply

검색결과 101건 처리시간 0.024초

감기약 콘택600 제조물책임사건에 관한 민사법적 고찰 - 대법원 2008.2.28. 선고 2007다52287 판결 - (A Study on the Product Liability Case of a Cold Medicine CONTAC 600 in Terms of Civil Law)

  • 전병남
    • 의료법학
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    • 제10권1호
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    • pp.213-260
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    • 2009
  • While the medical supplies have positive functions such as extending lifespan, recovering health, and preventing diseases, they also cause unexpected tragic consequences due to their side effects, and the magnitude of such damage inevitably increases due to the mechanism of mass production, mass distribution, and mass consumption of those medical supplies. Therefore, needless to say, the optimal way to prevent or reduce such damage is rather through medical supply manufacturers' producing non-defective products, or through the government's controlling production and sales of medical supplies with more aggressive exercise of regulatory authority on medical supply manufacturers, than through a remedy by a legal relief after using medical supplies. In this case, although the victim died due to the defect of the cold medicine, 'CONTAC 600', the drug company's responsibility to cover damages was not recognized because a defect could not be found in the then-manufacturing process. Thus, while pharmaceutical companies are gaining economic profits by producing and selling a medical supplies, if they do not take any remedy measures for the victims of their products' side effects, the victims have to use medical supplies under their own responsibility of taking a risk, and they have to accept the full damage of the potential consequence. Therefore, to remove such absurdity and contradiction, and to practically remedy the victim of medical supplies' side effects, the pharmaceutical side effects remedy project pending in the the Drugs, Cosmetics and Medical Instruments Lawneeds to be actively implemented.

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Expression of ERCC1, RRM1 and LRP in Non-small Cell Lung Cancers and their Influence on Chemotherapeutic Efficacy of Gemcitabine Concomitant with Nedaplatin

  • Qiu, Zhen-Qin;Zhao, Kun
    • Asian Pacific Journal of Cancer Prevention
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    • 제15권17호
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    • pp.7303-7307
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    • 2014
  • Objective: To explore the clinical efficacy of gemcitabine concomitant with nedaplatin and drug resistance in the treatment of non-small cell lung cancer (NSCLC) and associated molecular predicators. Materials and Methods: A total of 68 patients diagnosed with NSCLC by histology served as the study objects and were randomly divided into an observation group treated with gemcitabine concomitant with nedaplatin and a control group with cisplatin concomitant with gemcitabine, 34 cases for each group. Short-term and long-term efficacies, adverse responses as well as the expression of nucleotide excision repair cross complementing 1 (ERCC1), ribonucleotide reductase subunit M1 (RRM1) and lung resistance-related protein (LRP) in NSCLC tissues in both groups were assessed. Results: The short-term objective response rate (ORR) and disease control rate (DCR) were 35.3% (12/34) and 76.5% (26/34) in the observation group and 38.2% (13/34) and 85.3% (29/34) in the control group, respectively, the differences not being statistically significant. The time to progression (TTP) in both groups were 1~12 months, while the median TTP was 135 d and 144 d, respectively. Though the survival was slightly higher in the control group, there were no significant differences in TTP and survival time. The rates of decreased hemoglobin, vomiting and nausea as well as renal toxicity were evidently lower in the observation group, while other adverse responses demonstrated no significant difference. The positive expression rates of ERCC1, RRM1 and LRP were 47.1% (16/34), 61.8% (21/34) and 64.7% (22/34) in the observation group, respectively. Compared with negative ERCC1 expression, ORR had decreasing trend and the overall survival time (OS) decreased significantly in patients with positive ERCC1 expression, which were markedly decreased by the positive expressions of RRM1 and LRP. Conclusions: Gemcitabine concomitant with nedaplatin has significant effects in the treatment of NSCLC, with an adverse response rate obviously lower than for cisplatin concomitant with gemcitabine, suggesting that wider use in the clinic is warranted. Additionally, the positive expressions of ERCC1, RRM1 and LRP may increase patient drug resistance, so they can be applied as the chemotherapeutic predicators to guide individualized therapy of NSCLC patients.

Real-Time Monitoring of Mitochondrial ATP Synthesis and Hydrolysis by Surface Infrared Spectroscopy

  • Yamaguchi, Ryo-Taro;Hirano-Iwata, Ayumi;Aonuma, Yuki;Yoshimura, Yuya;Shinohara, Yasuo;Kimura, Yasuo;Niwano, Michio
    • 한국진공학회:학술대회논문집
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    • 한국진공학회 2013년도 제44회 동계 정기학술대회 초록집
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    • pp.108-109
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    • 2013
  • Mitochondria play key roles in the production of cell's energy. Their dominant function is the synthesis of adenosine 5'-triphosphate (ATP) from adenosine diphosphate (ADP) and phosphate (Pi) through the oxidative phosphorylation. Evaluation of drug-induced mitochondrial toxicity has become increasingly important since mitochondrial dysfunction has recently been implicated in numerous diseases including cancer and diabetes mellitus. Mitochondrial functions have been monitored via oxygen consumption, mitochondrial membrane potential, and more importantly via ATP synthesis since ATP synthesis is the most essential function of mitochondria. Various analytical methods have been employed to investigate ATP synthesis in mitochondria, including high performance liquid chromatography (HPLC), bioluminescence technique, and pH measurement. However, most of these methods are based on destructive analysis or indirect monitoring through the enzymatic reaction. Infrared absorption spectroscopy (IRAS) is one of the useful techniques for real-time, label-free, and direct monitoring of biological reactions [1,2]. However, the strong water absorption requires very short path length in the order of several micrometers. Transmission measurements with thin path length are not suitable for mitochondrial assays because solution handlings necessary for evaluating mitochondrial toxicity, such as rapid mixing of drugs and oxygen supply, are difficult in such a narrow space. On the other hand, IRAS in the multiple internal reflection (MIR) geometry provides an ideal optical configuration to combine solution handling and aqueous-phase measurement. We have recently reportedon a real-time monitoring of drug-induced necrotic and apoptotic cell death using MIR-IRAS [3,4]. Clear discrimination between viable and damaged cells has been demonstrated, showing a promise as a label-free and real-time detection for cell-based assays. In the present study, we have applied our MIR-IRAS system to mitochondria-based assays by monitoring ATP synthesis in isolated mitochondria from rat livers. Mitochondrial ATP synthesis and hydrolysis were in situ monitored with MIR-IRAS, while dissolved oxygen level and solution pH were simultaneously monitored with O2 and pH electrodes, respectively. It is demonstrated that ATP synthesis and hydrolysis can be monitored by the IR spectral changes in phosphate groups in adenine nucleotides and MIR-IRAS is useful for evaluating time-dependent drug effects of mitochondrial toxicants.

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당종해(唐宗海)의 의역사상(醫易思想)에 관(關)한 연구(硏究) (The study of Tang Zong Hai's Medica-change thought)

  • 김기욱;박현국
    • 대한한의학원전학회지
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    • 제12권2호
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    • pp.56-71
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    • 1999
  • 1. In the recohnition of cosmos true form, It is compared to the Boundless(無極) the Great Absolute(太極),Yin and Yang(兩儀) throungh the fertilazation process of spermatozoon and ovum. 2. It is explained that principle of unchange through the Form and Action(體 用) relation of the outer appearances and Number (象數) with matching the number of nine and ten to HaDoo(河圖) and RakSye(洛書). 3. Eigth divinations(八卦) being compared to the human body, Care presevation of pregnancy(養胎) is explained that head forms firstly(Gun-I 1乾一), secondly lung(Tae-E 兌二), heart(E-Sam 離三), liver(Jin-Sa 震四), gall bladder(Son-Oo 巽五), kidney(Gam-Yuk 坎六), intestines and stomach(Gan-Chill 艮七), lastly flesh forms(Gon-Pal 坤八). 4. It is explained that process of physiological change of $\ll$Nei Ching The Natural Truth in Ancient Times$\gg$(內經 上古天眞論) by matching boy at the age of 8 to Gan-divination(艮卦), and girl at the age of 7 to Tae-divination(兌卦). 5. The theory of six sons from Gun-Gon(乾坤六子論) is explained by relation of Apriority Eight-divination(先天八卦) obedience and disobedience-left and right. 6. It is explained that form of the human-body and the relationship of the Heart - the Kidney through the Gam(坎) Li(離) - divination 7. The effort of interpretating time and space of the Twelve Horary signs is explanined by season, direction, Five elements(五行), rise and decline, the Three Sum(三合), the Six Sum (六合), the six crash(六衡)'s relation. 8. the process of change from apriority(先天) to postery(後天) in the book of Changes(周易) is explanined by comparing to the phenomenum of nature and the human body. 9. The Energy Satus(氣位) are different from the direction of Eight-divination(八卦) and the properties of the good or bad of herb-drugs are differnt from the place of production. 10. The rightness of realizating the Overlapping-divinations(重卦) are compared to the phenomenum of nature through the Divination Virture(卦德). 11. The dependence-relations of The Twelve Meridians(十二經脈) are explained by-matching January with liver meridian, February with gall bladder meridian, march with heart pericardium meridiam, April with small intestine meridkan, August with lung spleen meridian, jury with stomach meridian, August with lung meridian, September with large intestine meridian, October with urinary bladder meridianm November with kidney meridian. December with triple energizer meridian throng The Twelve Byuk-divination. 12. The process of menstration cycle is explained by The Month symbolizing-divination(月候卦). 13. Through The Trade(交易) prove the reason of feverish sympotoms to use feverish Drug, mill sympotoms to use mill drug of prescription and Heart-Kidneys Consensus(心賢相交) and through The Change(變易), prove the chill and feverish consensus of forechill after feverish, fore feverish after chill and through. The Non-Change(不易) explain the reason of chill sympotoms to use feverish drug, feverish sympotoms to use chill drug of prscription. 14. Ho-divination(互卦) applicate Jxa Sa(佐使) herb drug match of Kun Sin Jwa Sa() theory. 15. According to the Hyo-position(爻位) match the ages, body form and drug by matching Ehight-divination(八卦) to the human body form and function in medicine and the book of Changes(周易) application emphasize the human body Ehight-divination(人身八卦). 16. Throgh the Order-divination(序卦) explain the rightness of Divination Image(卦象) arrangement and all things take shape by cosmo-energy conseusus(宇宙氣交). 17. Throgh the Mixing-divination(難卦) supply the vacancy of medicine and the book of Changes(周易) relationship in the foreword explian the human energy movements, sleep, vomitting, the energy arrival(逮氣), heart pericardium(心包), lung membrane(肺膜) etc.... Like the above sentence medicine and the book of Changes(周易) theory of scholar Tang on the viewpoint of easten-the way Western appliance(東道西器) researching abyss of medicine impart to descendants, so I think that the achievement of medicine and the book of Changes(周易) study is very excellant and I expect that the study Korean Oriental Medicine(韓醫學) theory by means of medicine the book of Changes(周易) reference, will be accelarated.

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Food Composition Database in Korea

  • Chun, Hye-Kyung;Park, Hong-Ju;Lee, Sung-Hyeon
    • Nutritional Sciences
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    • 제7권1호
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    • pp.47-52
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    • 2004
  • The food composition database is used to evaluate the nutritional value of foods in Korea. It is used as a source for basic data in many fields, not only for the establishment of the National Food Supply Plan but also for nutritional research, to aid in the drafting of the National Food Policy, and in clinical and epidemiological research. The database is also used by institutional and commercial food services and by the food processing industry among others. In 1970, the Rural Development Administration(RDA) published the "Korean Food Composition Table" for the first time and it has since become the established authority on food composition for the entire nation. The latest published food composition table (the 6th edition, published by the National Rural Living Science Institute, KDA) covers 2,337 kinds of foods and consists of two volumes. The National Rural Living Science Institute, the Korea Food and Drug Administration, and the National Fisheries Research and Development Institute have continuously improved production of food composition data in Korea. As consumers have grown more interested in the quality and safety of foods and raw agricultural products, we can expect even further development of food composition data through improvements in quality and increases in quantity. We need to develop more comprehensive food composition data by diversifying the kinds of foods that are included, unifying analytical methods, and increasing the number of nutrients covered. Moreover, food composition data must be modified in other ways to make for a better food composition database for the convenience of users. of users.

RFID 비즈니스 이벤트의 생성을 위한 시뮬레이션 모델 (A Simulation Model for the Creation of RFID Business Events)

  • 류우석
    • 한국정보통신학회논문지
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    • 제17권11호
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    • pp.2609-2614
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    • 2013
  • 물류, 의약품, 병원 등 다양한 환경에서 RFID의 도입이 확산되고 있다. RFID의 도입을 위해서는 EPC정보서비스(EPCIS)등과 같은 핵심 RFID S/W의 성능 및 적합성 평가가 선행되어야 하며, 이때 다양한 종류의 비즈니스 이벤트 데이터셋이 필수적으로 요구된다. 본 논문에서는 RFID 응용환경을 시뮬레이션하는 접근방법을 통해 보다 실제와 유사한 RFID 비즈니스 이벤트 데이터셋을 생성하기 위한 기법을 제안한다. 제안하는 모델은 페트리넷을 기반으로 하여 다양한 RFID 환경에 대한 유연한 표현이 가능한 특징이 있다. 또한, 실제 RFID 환경의 시뮬레이션이 가능함에 따라 RFID 도입여부 검토에서도 유용하게 활용될 수 있다.

日本における 藥用植物の生産, 消費の 現況 (The Present Condition of Production and Consumption of Medicinal Plants in Japan)

  • Kawahara, Nobuo
    • 한국자원식물학회지
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    • 제6권1호
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    • pp.33-44
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    • 1993
  • The medicinal plants used traditional medicines are classified into two groups. The first group is formulary medicine which have been recorded on authorized books, for example, kampo drug in Japan. The second group is the fork medicines. These medicinal plants production is 165 billion yen(about 1.5 billion dollar) and which rate to to total pharmaceutical production is about 3% in 1990. The number of important medicinal plants treated in the market is 124 herbs from the total 364 herbs for kampo durgs(210 preparations kampo durgs) and other propritetary drugs (agents for common cold, laxatives, gastrointestional and so on). The production of the Ginseng and Bupleurum Root are increased about ten times in last twelve years(1976 or 1988). The 80% of these medicinal plants are imported from China, Korea and Southern Asian countries. Then the Pharmaceutical Affairs Bureau of Ministry of Health and Welfare published "The Guideline of Medicinal Plant for Cultivation" for a quality control and a stabilization supply of 80 herbs. The first part(1992) of the guideline reported 5 herbs; Coptis Rhizome, Rehmannia Root, Bupleur, Root, Japanese Angelica Root and Rhubarb, The next part will be published following 5herbs; Cnidium Rhizome, Safflower, Coix seed and Fruiet, Platicodon Root and Zedoary.

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응급구조(학)과 학생의 구급차 동승실습 술기시행 관련 요인 (Related factors involved in the direct practice of practical procedures during the ambulance ride practice of paramedic students)

  • 김성주
    • 한국응급구조학회지
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    • 제19권3호
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    • pp.87-101
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    • 2015
  • Purpose: The purpose of this study was to provide an appropriate direction for an effective field practice program by analyzing the factors related to practical procedures in the ambulance ride practice of paramedic students in Korea. Methods: Questionnaires were answered by 202 paramedic students from March 28 to April 15, 2014. The collected data were analyzed with SPSS WIN 18.0 program. Results: The general level of procedural exposure during ambulance ride practice was 59.0% on average. Considering the practice of specific areas, vital sign checking, patient assessment, and oxygen supply showed relatively high percentages of 92.3%, 77.4% and 72.6%, respectively, whereas the areas of fluid and drug, airway, and cardiopulmonary resuscitation recorded relatively low percentage of 25.8%, 24.1% and 50.2%, respectively. The level of direct practice was significantly high in the group that included the largest number of paramedics. Conclusion: For an effective field practice, the place of practice needs to have various cases of patients to ensure a wide experience of procedures during the practice, and ambulance workers with a high level of expertise should be selected to ride with students.

Shikimate Metabolic Pathway Engineering in Corynebacterium glutamicum

  • Park, Eunhwi;Kim, Hye-Jin;Seo, Seung-Yeul;Lee, Han-Na;Choi, Si-Sun;Lee, Sang Joung;Kim, Eung-Soo
    • Journal of Microbiology and Biotechnology
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    • 제31권9호
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    • pp.1305-1310
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    • 2021
  • Shikimate is a key high-demand metabolite for synthesizing valuable antiviral drugs, such as the anti-influenza drug, oseltamivir (Tamiflu). Microbial-based strategies for shikimate production have been developed to overcome the unstable and expensive supply of shikimate derived from traditional plant extraction processes. In this study, a microbial cell factory using Corynebacterium glutamicum was designed to overproduce shikimate in a fed-batch culture system. First, the shikimate kinase gene (aroK) responsible for converting shikimate to the next step was disrupted to facilitate the accumulation of shikimate. Several genes encoding the shikimate bypass route, such as dehydroshikimate dehydratase (QsuB), pyruvate kinase (Pyk1), and quinate/shikimate dehydrogenase (QsuD), were disrupted sequentially. An artificial operon containing several shikimate pathway genes, including aroE, aroB, aroF, and aroG were overexpressed to maximize the glucose uptake and intermediate flux. The rationally designed shikimate-overproducing C. glutamicum strain grown in an optimized medium produced approximately 37.3 g/l of shikimate in 7-L fed-batch fermentation. Overall, rational cell factory design and culture process optimization for the microbial-based production of shikimate will play a key role in complementing traditional plant-derived shikimate production processes.

Digital Transformation Shift in Global Pharmaceutical Industry Going through the Covid-19 Pandemic Era

  • Il Seo;Hak Kyun Yang;Min Joon Seo;Sung Hyun Kim;Jin Tae Hong
    • Asian Journal of Innovation and Policy
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    • 제12권1호
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    • pp.054-074
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    • 2023
  • With the advent of the '4th Industrial Revolution', digitalization using AI (Artificial Intelligence), big data, IoT (Internet of Things), cloud computing and mobile is accelerating across all industries and global companies have fundamentally reorganized customer experiences, business models, and operations centering on digital transformation. Business innovation drives productivity improvement, process simplification, price, competitiveness and sustainable expansion. Whether digital transformation will be necessary for the current industrial environment is no longer important, and how quickly companies achieve digitalization has emerged as the utmost crucial element in industrial continuity. As non-face-to-face and remote technologies have begun in earnest, and accelerated in the pharmaceutical industry. They are looking for ways to provide value, generate profits, improve efficiency, and sustain the future. Compared to other industries, the pharmaceutical-related sectors have shown high interest in digital transformation especially to reduce costs and meet the challenge of delivering products during the pandemic environment.