• Title/Summary/Keyword: Drug package

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A Systematic Review on Drug Safety for Molsidomine, Nicorandil and Trimetazidine (Molsidomine, Nicorandil, Trimetazidine의 안전성 관련 체계적 고찰)

  • Jeong, Kyeong Hye;Lee, Euni
    • Korean Journal of Clinical Pharmacy
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    • v.26 no.2
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    • pp.172-180
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    • 2016
  • Background: Ischemic heart disease is the most common type of heart disease and an important cause of death in Korea. Among marketed anti-anginal medications, molsidomine, nicorandil, and trimetazidine are approved in Korea with unique mechanism of actions. As these drugs are not approved by the US Food and Drug Administration, the access to the up-to-dated and comprehensive safety-related information has been less than optimal from drug information resources used by Korean pharmacists. Methods: A systematic review was conducted using Embase and Korean manuscripts to compile safety updates for these medications. Out of 418 articles from keyword searches, 52 studies were reviewed in full to compare adverse effects (AEs) with the approved package inserts (PI). Results: Molsidomine related adverse effects were mostly mild or moderate, but anxiety, palpitation, epigastric pain, and sexual potency reduction were additional AEs found from the review not listed in PI. Although PI has included ulceration in oral cavity and gastrointestinal tracts including anus by nicorandil, the Korea FDA recently recommended adding corneal, genital, and skin ulcers to the approved PI. Trimetazidine induced Parkinsonism, worsening of the symptoms for patients diagnosed with Parkinson's disease, gastrointestinal burning, and muscle cramps were additionally identified AEs not listed in PI for trimetazidine. Conclusion: Continuous evaluations of the safety profile of these agents are needed to balance the risks and benefits to provide evidence-based safety counseling to the patients. In addition, more focused efforts on spontaneous reporting are warranted by healthcare professionals to safeguard patients against AEs.

Effect of the Erimental Design on the Determination of MTD in Phase I Clinical Trial (약물독성시험에서 실험설계가 MTD의 결정에 미치는 영향)

  • Lee, Yoon-Dong;Lee, Eun-Kyung
    • Journal of Korean Society for Quality Management
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    • v.39 no.2
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    • pp.329-336
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    • 2011
  • The purpose of Phase I clinical trial is to identify the maximum tolerated dose with specific toxicity rate. The standard TER design does not guarantee the pre-specified toxicity rate. It depends on the dose-toxicity curves. Therefore it is necessary to check the expected toxicity rate of various dose-toxicity curves before we conduct clinical trials. We developed TERAplusB library to help this situation, especially in cancer research. This package will help design the cancer clinical trial. We can compare the expected toxicity rates, the expected number of patients, and the expected times calculated with various dose-toxicity curves. This process will help find the best clinical trial design of the proposed drug.

Studies on the Substance of Migration for Retort Pouch Packaging Materials for Various Condition (레토르트 파우치 포장재의 사용조건에 따른 이행물질의 조사)

  • Lee, Man-Sul;Song, Beum-Ho;Park, Sun-O;Lee, Bu-Young;Lee, Young-Za;Youn, Hey-Kyung;Eum, Mi-Ok;Seung, Ju-Heung;Jeun, Dae-Hoon
    • KOREAN JOURNAL OF PACKAGING SCIENCE & TECHNOLOGY
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    • v.13 no.3_4
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    • pp.107-112
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    • 2007
  • The effect of microwave heat to retort pouches and microwavable packages was examined. 186 products were collected, but packages were consisted of five package materials such as PET, Aluminum foil, Nylon, EVOH, and polypropylene. The results showed that all packages did not exceed the limits of current packaging regulation on consumption weight of $KMnO_4$, TDI(Toluene diisocyanate), and Caprolactam. Safety control on heat resistant packages considered satisfactory, but investigation on new substances should be continued for preventing any possible migration problems of packaged foods.

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Basic Knowledge Level of Nurses on the Administration of Medication (투약에 관한 간호원의 기초지식 정도)

  • 한윤복;이인자;김명자;노유자
    • Journal of Korean Academy of Nursing
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    • v.6 no.1
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    • pp.12-22
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    • 1976
  • Amongst varieties of clinical nursing role, the administration of medication is often highlighted as of prime importance. In order to attain data for the improvement of teaching strategies of medication, diagnostic evaluation of the knowledge level is a necessity. This study was performed from August through December 1975. 449 registered nurses, randomly sampled from general hospitals:16 of Seoul and 7 of Taegu and Pusan, were tested through 54 test questionaries based on 4 practical dimensions of administration of medication. Results are as follows ; 1. Status of respondents: Length of clinical experiences; the average length revealed to be 2 years and 7 months, 72% revealed to have had less than 3 years of experience; 38.6%-less than 1 year, 19 .2%-over 1 year and less than 2 years, and 14, 2%-over 2 years and less than 3 years. Type of Nursing education received ; 9.4% revealed to have graduated technical high school of nursing, 67.5o/o the 3 year diploma school and 21, 7% the baccalaureate degree program. The knowledge Level; Degree of self-satisfaction on knowledge level revealed that;27, 4% responded to "more or less satisfied", 48.8% "more or less un-satisfied" and 19.8% to "not satisfied". The average level of basic knowledge revealed to be moderate by 66.95 points. The level of knowledge of 4 questionnaire categories revealed that; drug action category by average of 66.5 points, methodology category by 65.4 Points, safety measure category by 71.4 points and terminology and concepts category by 64.6 points, Questionnaire items which revealed high points are of;6 of drug action category, 4 of methodology, 4 of safety measure, and 3 of terminology. The items of low points are: 8 of drug action, 3 of methodology, 3 of safety measure and 5 of terminolology categories. 3. The type of nursing education revealed to have no significant influence on the level of knowledge on the administration of medication. 4. The length of clinical experience revealed to have no significant influence on the level of knowledge. 5. 75. l% responded that the actual practice of medication modes are "similar" to that included in the fundamentals of nursing course. 6. In-service education on medication; 54.0% revealed to have some incidental in-service education on medication while 34.0% receive programmed in- service education. 61.8% revealed to have expressed the need of systemic In-service education as one of the means for improvement of medication. 32.7% revealed to obtain information concerning medicine by reading commercial publications on drug package, while only 20.9% by reading specific information channel.

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Concurrent Use of Nefopam vs. Ketorolac with Opioid Analgesic for Post-operative Pain Management (수술 후 통증조절 목적으로 펜타닐과 병용되는 네포팜 vs. 케토롤락의 사용현황)

  • Kim, Yoon Hee;Kim, Young Won;Choi, Kyung Suk;Lee, Jung Hwa;Lee, Eunsook;Kim, Seungyeon;Choi, YoungRok;Lee, Euni
    • Korean Journal of Clinical Pharmacy
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    • v.28 no.4
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    • pp.279-284
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    • 2018
  • Objective: To compare the analgesic effects and adverse drug reactions (ADRs) of fentanyl intravenous patient-controlled analgesia (ivPCA) with nefopam, a centrally acting analgesic agent with demonstrated opioid sparing activity, as compared to ketorolac in a tertiary teaching hospital. Methods: A retrospective evaluation of electronic medical records was conducted on patient records including either nefopam or ketorolac with opioid ivPCA for post-operative pain management in general surgery department from January to December 2014. The status of pain control and ADRs were collected. Results: Out of 6,330 general surgery cases, nefopam was given in 153 prescriptions (6.9%) and ketorolac in 81 prescriptions (3.6%). The level of pain control was not different between two groups (70.9% vs. 75.3%; p = 0.51), but ADRs were more frequently reported in nefopam group (9.8% vs. 2.5%; p < 0.05). New ADRs of hot flushes (n = 1) and paresthesia in hands (n = 1) were reported in nefopam group and they were unlisted in the approved package insert. No serious ADRs were reported in both groups. Conclusion: Our findings presented that nefopam showed a similar analgesic effect and higher ADR rates compared to ketorolac as an adjuvant to fentanyl iv PCA for post-operative pain management in general surgery patients in South Korea.

Investigation on the Safety of Hydroquinone and Preservatives among Whitening Functional Cosmetics Containing Albutin in Korea (국내 유통 알부틴 함유 미백 기능성화장품 중 히드로퀴논 및 살균보존제 안전성 조사)

  • Cho, Joong Hee;Kim, Ji Hyeung;Eom, Sun Ah;Kang, Min Jeong;Han, Young Sun;Hur, Myong Je
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.45 no.4
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    • pp.399-408
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    • 2019
  • Arbutin, which is used as a whitening ingredient, can produce hydroquinone, known as causing skin disease and carcinogen. Preservatives are essential to prevent microbial contamination during long-term storage and use of cosmetics, but safety issues such as toxicity and skin irritation are being raised. This study was conducted to determine hydroquinone and 21 preservatives levels in 40 arbutin-containing whitening functional cosmetics sold on-line and off-line. Result showed that 9 products contained hydroquinone. The concentrations in 7 products were ranged from 0.3 to 0.9 ppm, which were within the maximum allowed amount established by the Ministry of Food and Drug Safety. However, 2 products were 8.4 and 50.5 ppm and exceeded the allowed amount. Preservatives were detected 20 products. Detected items and ranges were phenoxy ethanol 0.1 ~ 0.7% (N = 15), Methyl paraben 0.19 ~ 0.21% (N = 2), Chlorphenesin 0.13% (N = 1), chlorhexidine 0.006% (N = 1), Propyl paraben 0.06% (N = 1), which were within maximum allowed amount established by the Ministry of Food and Drug Safety. Also, in cases of functional cosmetics the phrase "functional cosmetics" should be expressed on the primary or secondary package of cosmetics by cosmetics act. However, 1 product did not state the phrase as functional cosmetics. This study suggest that preservatives were safely managed. However, hydroquinone in hydroquinone-detected products could be produced by the decomposition of arbutin. Thus, further studies on the decomposition of arbutin are required to improve the quality control of the cosmetics.

The Recognition and Requirement of Nutrition Labeling in Fast-Food Restaurants (패스트푸드업체에서 실시할 영양표시제 인식 및 필요성 분석 - 서울시를 중심으로 -)

  • Chung, Hea-Jung;Cheon, Hee-Sook;Kwon, Kwang-Il;Kim, Jee-Young;Yoo, Kwang-Soo;Lee, Jun-Hyung;Kim, Jong-Wook;Park, Hye-Kyung;Kim, So-Hee;Hong, Soon-Myung
    • Journal of Nutrition and Health
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    • v.42 no.1
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    • pp.68-77
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    • 2009
  • This study was researched to provide the accurate nutrition information and the menu. We questionnaired an recognition and necessity of the nutrition labeling to 684 customers in fast-food restaurants. After data cleaning, we used spss package 14.0 and analyzed about the nutrition contents and place that display the nutrition labeling. First, we finded out lower recognition of nutrition labeling in restaurants than processed food. Second, many people hoped that calory and fat in various nutritions were displayed each 100 g or 100 mL. Third, the place displaying the nutrition information was the menu board and the counter to identify easily. Fourth, we analyzed the recognition and necessity of the nutrition labeling in fast-food restaurants by t-test and ANOVA. So, we knew that the recognition and necessity of the nutrition labeling was higher woman than man. And the more they earn much money and learned, the more the nutrition labeling are needed. But house-wife recognized the nutrition labeling lower than others.

Application of time-temperature indicators for cooling and frozen food storage and distribution (저장 조건 감지 지표 장치의 특성 및 식품에의 응용 가능성)

  • An, Duek-Jun;Yoo, Seung-Seok
    • KOREAN JOURNAL OF PACKAGING SCIENCE & TECHNOLOGY
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    • v.5 no.1
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    • pp.25-29
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    • 1999
  • Time-temperature indicators (TTI) from three different companies obtained and were attached to food packages materials to evaluate degree of their color change according to storage time and temperature. Five temperature (-10 -5, 0, 5 and 10) was selected to represent standard freezing, refrigerating and room temperature, and evaluated performance by color change based on magnitude of color change and hunter system (L, a, b). Response end point was measured and recorded to find characteristic of each indicator. Comparison and discussion were conducted for accuracy and precision of each time-temperature. More research should be conducted at variable temperature and with various food to determine applicability of TTI on various storage condition.

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Involvement of GRP78 in the Resistance of Ovarian Carcinoma Cells to Paclitaxel

  • Zhang, Li-Ying;Li, Pei-Ling;Xu, Aili;Zhang, Xin-Chen
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.8
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    • pp.3517-3522
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    • 2015
  • Background: Glucose regulated protein 78 (GRP78) is a type of molecular chaperone. It is a possible candidate protein that contributes to development of drug resistance. We first examined the involvement of GRP78 in chemotherapy-resistance in human ovarian cancer cell. Materials and Methods: The expression of GRP78 mRNA and protein were examined by RT-PCR and western blotting, respectively, in human ovarian cancer cells line (HO-8910). Sensitivity of HO-8910 to paclitaxel was determined with methyl thiazolyl tetrazolium (MTT). Suppression of GRP78 expression was performed using specific small-interfering RNA (siRNA) in HO-8910 cells, and cell apoptosis was assessed by flow cytometry. Statistical analysis was performed using the SPSS 15.0 statistical package. Results: HO-8910 cells, with high basal levels of GRP78, exhibited low sensitivity to paclitaxel. The mRNA and protein levels of GRP78 were dramatically decreased at 24h, 48h and 72h after transfection and the sensitivity to paclitaxel was increased when the GRP78 gene was disturbed by specific siRNA transfection. Conclusions: The results suggested that high GRP78 expression might be one of the molecular mechanisms causing resistance to paclitaxel, and therefore siRNA of GRP78 may be useful in tumor-specific gene therapy for ovarian cancer.

Comparison of the Current Migration Testing Regulations for Plastic Containers and Packaging Materials in EU, USA and Korea or Japan (유럽연합, 미국, 한국 및 일본의 합성수지 용기.포장재에 대한 현행 이행실험 규정 비교)

  • Lee, Keun-Taik;Lee, Chang-Sung
    • KOREAN JOURNAL OF PACKAGING SCIENCE & TECHNOLOGY
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    • v.5 no.2
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    • pp.42-58
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    • 1999
  • Packaging materials and articles that are used in food contact applications can transfer constituents in the foodstuffs. This kind of risk of possible health hazards to consumers has been generally recognized for a long time with the consequence of establishing corresponding food regulations in most developed countries. However, the language of these laws, their interpretation, and their level of enforcement vary from country to country. Accordingly, the actual migrating levels from packaging materials can be varied depending on the migration testing methods as prescribed in the national legislation in each countries. Therefore, there are needs of elimination of non-tariff trade barriers raised by sanitary and phytosanitary or technical measures under the Final Act of the UR Agreement. In this connection, the EU and USA are currently in an ongoing process of legislation harmonization to overcome potential barriers to free trade. In general, regulations governing component transfer in the USA are more complicated and comprehensive than similar regulations in Europe. In future, standard migration testing procedures for microwave heat susceptor materials and for the use of fatty food simulant should be established and also harmonized among countries. The objective of this investigation is to compare the current regulations for migration testing for plastic containers and packaging materials in USA, EU and Korea or Japan. For those regulations, Korean standards are required to be kept up with the international standards. By doing this, the related Korean regulation could be amended along with the worldwide progress for harmonization.

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