• Journal of the Korea Academia-Industrial cooperation Society
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• v.11 no.6
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• pp.2240-2245
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• 2010

Myocardial imaging in SPECT (Single Photon Emission Computed tomography) scan of the gamma-ray emitting radiopharmaceuticals to patients after intravenous radiopharmaceuticals evenly spread in the heart region of interest by recording changes in the disease caused by a computer using the PSA test is to diagnose. Containing information on the functional myocardial perfusion imaging is a useful way to examine non-invasive heart disease, but the argument by noise and low resolution of the physical landscape that is difficult to give. For this paper, the level of myocardial imaging by using the three algorithms to split the video into 3-D implementation of the partitioned area to help you read the proposed plan. To solve the difficulty of reading level, interest in using the sheet set, partitioned area of the left ventricle was ranked the partitioned area was modeled as a 3-D images.

• Journal of Pharmaceutical Investigation
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• v.36 no.4
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• pp.239-243
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• 2006

Due to the development of new dosage forms and the improvement or pharmaceutics, the pharmaceutical excipients have become more specified and diverse, and the reclassification on them became necessary. Also with the increasing interests on the kinds and usage amount, related provisions, and evaluation of the pharmaceutical excipients, the systemic and effective control of them was in its demand. Therefore, in this research, we provided the following information on excipients: the type, amount and specification. In order to provide the information, we investigated, analysed and summarized the excipients that are approved by KFDA and published $\ulcorner$Handbook of Pharmaceutical Excipients$\lrcorner$). This handbook is expected to be used as a reference in the development of the pharmaceutics and evaluation in them. As the importance of excipients in pharmaceutics are increasing, IPEC which consist of IPEC-America, IPEC-Europe and JPEC, PDG and ICH have tried to make an international harmonization on excipient. This current status was not an exception to Korea, therefore, the result of this research is expected to make a progress in the evaluation on the excipients to an advanced level.

• The Journal of the Korea Contents Association
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• v.15 no.11
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• pp.386-396
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• 2015

The purpose of this study is to analyze the determinants of the effectiveness in food safety policy, focusing on the perception of consumers. For this, we apply ordered logit analysis using "The Survey on the Attitudes towards Food Safety Policy" data investigated by Ministry of Culture, Sports and Tourism & Ministry of Food, and Drug Safety. According to the results of the analysis, policy literacy has a significant positive impact on the effectiveness of the policy. Trust has a positive impact on the effectiveness of the policy significantly. In addition, the results show that sensitivity has a significant negative impact on the effectiveness perceived by consumers. This study imply that the government should give more information about policies and make an effort to gain trust on food safety policy.

• KDI Journal of Economic Policy
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• v.18 no.3_4
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• pp.3-61
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• 1996

소비자 보호 및 효율적 자원배분, 기업의 안전증진 유인제공, 제도의 국제적 조화를 위하여 제조물책임법(製造物責任法) 제정의 필요성이 제기되고 있다. 현재 제조물로 인한 사고는 민법(民法)에 의하여 보상받고 있으나 그 입증책임이 과중하고, 현재 우리나라 생산물배상책임보험(生産物賠償責任保險)이 전체 손해보험에서 차지하는 비중은 0.1%에 불과(미국 10%)하여 그 비용이 아직 미미하므로 제조물책임법제(製造物責任法制) 도입의 안전증진효과가 경제적 손실보다 클 것으로 예상된다. 법제정시의 기본방향은 소비자에게 단순히 보상을 제공하는 법제가 아닌, 기업의 책임과 제품결함이 밀접히 연관되어 배상(賠償) 및 사고억제(事故抑制)의 유인과 효과를 극대화하는 것이어야 한다. 추정규정의 도입은 소비자(消費者) 피해구제(被害救濟)를 용이하게 하지만, 디자인 및 경고결함(警告缺陷)과 결합되면 제조자가 제품사고의 모든 가능성에 대해 완벽한 정보를 가지지 않는 한 제조자의 책임이 되어 제조물책임(製造物責任)의 불확실성(不確實性)을 높이고, 결과적으로 기업에게 절대책임(絶對責任)을 부과하게 되어 제품개발과 혁신을 위축시키는 등의 부정적(否定的) 영향을 초래할 위험이 크다. 따라서 결함의 추정은 인정하지 않아야 하며, 제품개발 및 혁신을 도모하기 위해 개발위험항변(開發危險抗辯)은 인정되어야 한다. 손해배상액(損害賠償額) 상한(上限)을 두지 않는 것이 경제적으로 효율적이고 연대책임을 인정하여 유통업자의 안전제고유인(安全提高誘因)도 강화하는 것이 효과적이다. 중소기업을 포함한 모든 기업에게 입법후 1년 정도의 준비기간(準備期間)을 주는 것이 바람직할 듯하며, 배상책임보험(賠償責任保險)은 의무화하지 않는 것이 경제적으로 효율적이다. 기계, 전자, 운송용기기, 건설, 화학, 식 의약품, 가스제품, 완구, 운동용구 등이 영향을 크게 받을 것으로 예상되지만 법제이용(法制利用)의 편의가 개선되기 전에는 소송의 증가는 미미하리라 예상된다.

• Journal of the Society of Cosmetic Scientists of Korea
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• v.29 no.2 s.43
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• pp.251-270
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• 2003

Cosmetics have had only simple efficacy such as cleansing, beautification, and so on. The latest development tendency for cosmetics turned to make goods that is effective and efficacious for whitening, anti-wrinkle, etc., due to various wants of consumers, development of relative technical, etc. According to this stream, Korea Cosmetics Law has been enacted by the Notification of the Korea Food and Drug Administration in 2000. The establishment of Korea Cosmetics industry and opened regular 'Cosmeceuticals Time'. Since the Korea Cosmetics Law took effect on July 2000, the cosmeceuticals system has settled down according to its lights. This research studied how women consumers were understanding the cosmeceuticals system focused on their life style. This study is considered to offer a basic information about consumer's type and to be a groundwork data for working out a marketing strategy about the subdivision of cosmeceuticals market.

• Korean Journal of Clinical Pharmacy
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• v.24 no.4
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• pp.265-271
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• 2014

Objective: This study aims to explore the perception of off-label use of medications and the provision of informed consents from the general public's perspective. Methods: The study subjects (n=291) were recruited from 7 cities in Korea through a convenience sampling method. The self-administered questionnaire with 13 items was issued and collected. The study subjects who have had a pharmaceutical job were excluded. Results: The total of 231 respondents was included. Only 23% of respondents were familiar with the concept of off-label use of medications. Eighty five percent of respondents (n=196) stated that the prescribers should explain the off-label use of a medication to their patients. The preferred method for delivering the message was the oral explanation (n=122, 53%), followed by oral explanation plus a pamphlet (n=94, 41%). The safety issue is the most concerned aspect regarding the off-label drug use, also effectiveness and insurance coverage. The majority of respondents (n=217, 94%) agreed that the prescriber should get a consent from patients before prescribing medications for off-label use. They preferred written consent to oral consent (140 vs. 77). Conclusion: This study demonstrated general publics are infrequently aware of off-label use of medications. It is important to raise public awareness of the off-label use of medications and to openly discuss its pros and cons for safe and effective drug therapy.

• Journal of the Society of Cosmetic Scientists of Korea
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• v.28 no.1
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• pp.15-30
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• 2002

최근 화장품 사용인구의 증가와 안전성에 대한 관심 증대에 따라 화장품 중 유해성분 함유에 대한 논란이 종종 있어왔다. 화장품에 대한 전문적 지식이 없는 사람들에 의하여 진행된 잘못된 정보로 인하여 화장품 중에 포함된 모든 중금속이 인체에 심각한 영향을 초래한다는 등의 오해를 불러와 관련 업계에 적지 않은 피해를 주기도 하였다. 이에 본 자료에서는 구체적 근거자료와 연구 논문들을 기반으로 유해한 중금속, 안전하여 사용이 공인된 중금속 등을 조사하여 화장품에서의 중금속의 개념을 정립하고자 하였다. 국내에서는 식품의약품안전청 고시 제2000-27호에 화장품에 포함되었을 때 유해한 중금속으로 납, 비소 및 수은을 명시하고 그 규제농도를 규정하고 있다. 규제 중금속은 아니지만 피부에 알러지를 일으키는 중금속으로는 니켈이 있는데 화장품 중 몇몇 제품군에서 소량(수∼수십ppm) 이 검출되기도 한다. 그러나 이는 일상으로 사용하는 각종 귀금속, 시계, 안경테, 클립, 지퍼 등의 금속 용품에 포함된 니켈의 양(수∼수십%)에 비하여 매우 적은 양이며 정상적인 사람에게는 무해하다. 실제 대다수의 니켈 알러지는 화장품이 아닌 귀금속이나 시계 등의 금속류 제품 등에 의하여 유발된다. 또한 많은 종류의 중금속 화합물이 화장품 원료로 사용되고 있다. 전세계적으로 널리 사용되는 것으로 크롬, 망간, 비스머스, 구리, 철, 코발트, 티타늄, 아연 등의 화합물이 있으며 이들은 각종 화장품 공정서 및 원료집 등에 수재되어 사용되고 있다. 이들 중 코발트와 크롬이 피부에 유해하다는 몇몇 보고가 있지만, 이는 이들 원소의 수용성염형태의 특정 화합물인 cobalt chloride와 chromate 및 dichromate의 염에 관한 것으로 화장품에서 사용되는 불용성 산화물인 cobalt aluminum oxide, cobalt titanium oxide, cobalt blue, chromium oxde greens 및 chromium hydroide green 등, 국제적으로 널리 사용되는 안전한 중금속 화합물과는 그 특성 및 독성이 판이하게 다르다. 따라서 화장품에서는 매우 안전한 중금속 화합물만이 사용된다. 업계는 유해 중금속에 관해서는 규제에 입각한 엄격한 품질관리에 힘쓰고 중금속의 화학적 분자구조(수용성염 vs 불용성산화물)를 구별할 수 있는 분석방법 개발에 주력하여야 한다. 그리고 안전한 화장품을 사용하고자 하는 소비자의 욕구를 충족시키고 잘못된 인식과 보도로 인하여 안전한 화장품이 유해한 것으로 오도되는 것을 막아야 할 것이다.

• Journal of Convergence for Information Technology
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• v.10 no.12
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• pp.166-174
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• 2020

Cosmetic functional ingredients are products of emotional convergence technology. Unlike pharmaceuticals, it is very important that cosmetics ingredients contain emotional attractiveness because they are household products that have limitations in their effectiveness. Ginseng has long been used as a major prescription of oriental medicine for human health. Detailed records such as the origin and propagation of ginseng can lead to various cosmetical application of ginseng as an emotional convergence ingredients that utilizes the authenticity and excellence of ginseng as an asset of K-beauty. In the unfortunate reality that the first records of ginseng use depend on ancient Chinese literature, it is very meaningful to describe and leave the records of ginseng used in the field of beauty. This study examined the general historical records needed for the study of the cosmetics application of ginseng and the recent findings of ginsenoside in the area of skin function, and provided basic data that can be applied to new cosmetics development research.

• Korean Journal of Clinical Pharmacy
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• v.31 no.1
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• pp.53-60
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• 2021

Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. Methods: We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. Results: All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. Conclusion: All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission. Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.

• Korean Journal of Clinical Pharmacy
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• v.31 no.4
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• pp.324-331
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• 2021

To investigate signals of adverse drug reactions of finasteride by using the Korea Adverse Events Reporting System (KAERS) database. This pharmacovigilance was based on the database of the drug-related adverse reactions reported spontaneously to the KAERS from 2013 to 2017. This study was conducted by disproportionality analysis. Data mining analysis was performed to detect signals of finasteride. The signal was defined by three criteria as proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). The signals of finasteride were compared with those of the other drugs; dutasteride (similar mechanism of action), minoxidil (different mechanism but similar indications for alopecia), silodosin (different mechanism but similar indications for BPH). It was examined whether the detected signals exist in drug labels in Korea. The total number of adverse event-drug pairs was reported 2,665,429 from 2013 to 2017, of which 1,426 were associated with finasteride. The number of investigated signals of finasteride was 42. The signals that did not include in the drug label were 29 signals, including mouth dry, hypotension, dysuria etc. The signal of finasteride was similar to that of dutasteride and silodosin but was different to that of minoxidil. Early detection of signals through pharmacovigilance is important to patient safety. We investigated 29 signals of finasteride that do not exist in drug labels in Korea. Further pharmacoepidemiological studies should be needed to evaluate the signal causality with finasteride.