• Journal of Pharmaceutical Investigation
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• 제34권1호
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• pp.57-71
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• 2004

The objective of this study was to provide a better understanding of SUPAC-IR and its application in handling postapproval changes to immediate release solid oral dosage forms. Originally, SUPAC-IR was aimed at reducing the regulator burdern of the industry when they were making postapproval changes, but still at maintaining the formulation quality and performance of a drug product. The postapproval changes that were covered under SUPAC-IR included variations in the components ad composition of formulation, the site of manufacturing, batch size, manufacturing equipment, and manufacturing process. The guidance defined levels of changes, based on the likelihood of risk ocurrence and potential impact of postapproval changes upon the safety and efficacy of a drug product I suggested what a type of fing report should be submitted to the FDA for each level of change. Chemist, manufacturing, and control tests to be executed were also recommended for each change level The important tests specified in the guidance included batch release, stability, in vitro dissolution, and in vivo bioequivalence tests. However, there have been strong demands on revising the current SUPAC-IR in order to resolve some issues and to improve its usefulness in evaluating postapproval changes to immediate release solid oral dosage forms. In particular, the rigorous requirement of case C dissolution test and the definition of batch size were challenged by both academia and the industry. A revision work was in progress to reflect these inputs and to expand the utility of SUPAC-IR. As a result of these concerted efforts, an updated 2nd version of SPAC-IR would be likely to be issued ver soon to the public.

• 한국가스학회지
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• 제22권2호
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• pp.29-33
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• 2018

전통시장, 지하상가 등에서는 많은 유동인구가 있고 가스 전기 설비가 동일구내에 설치되어 두 에너지원의 연관성에 의한 사고 가능성이 증대되고 있으며, 이러한 사고를 예방하고 신속 대응하기 위한 방안이 필요하다. 이 연구에서는 위험인자와 관련된 영향인자 센싱을 통해 사고예측을 하는 것을 목표로 한다. 전기적요인의 누설전류, 아크 등과 폭발사고 위험과 관련된 가스누출에 대해 IOT 센서를 통한 사고예방을 할 수 있는 안전관리 플랫폼 개발의 연구이며 이 논문에서는 가스 사고와 관련된 화재위험인자를 고려한 사고예측에 대한 연구내용이다. 이러한 사고위험을 예방하기 위해서 연소기 주위에서의 온도변화 특성 분석을 수행하였고, 이를 고려하여 화재를 예방할 수 있는 사고전조 알고리듬과 관련된 모듈을 개발하였다.

• Journal of Korean Neurosurgical Society
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• 제55권1호
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• pp.26-31
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• 2014

Objective : Early decompressive craniectomy (DC) has been used as the first stage treatment to prevent secondary injuries in cases of severe traumatic brain injury (TBI). Postoperative management is the major factor that influences outcome. The aim of this study is to investigate the effect of postoperative management, using intracranial pressure (ICP) monitoring and including consecutive DC on the other side, on the two-week mortality in severe TBI patients treated with early DC. Methods : Seventy-eight patients with severe TBI [Glasgow Coma Scale (GCS) score <9] underwent early DC were retrospectively investigated. Among 78 patients with early DC, 53 patients were managed by conventional medical treatments and the other, 25 patients were treated under the guidance of ICP monitoring, placed during early DC. In the ICP monitoring group, consecutive DC on the other side were performed on 11 patients due to a high ICP of greater than 30 mm Hg and failure to respond to any other medical treatments. Results : The two-week mortality rate was significantly different between two groups [50.9% (27 patients) and 24% (6 patients), respectively, p=0.025]. After adjusting for confounding factors, including sex, low GCS score, and pupillary abnormalities, ICP monitoring was associated with a 78% lower likelihood of 2-week mortality (p=0.021). Conclusion : ICP monitoring in conjunction with postoperative treatment, after early DC, is associated with a significantly reduced risk of death.

• 한국전자거래학회지
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• 제20권2호
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• pp.93-106
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• 2015

전자상거래의 성립을 위해 온라인 정보시스템 상에서 거래 당사자의 정보를 제공하는 것은 필수적이다. 거래의 간편성을 위해 서비스 제공 기업이 이를 보관하고 개인정보와 거래 정보를 가공하여 추가 서비스를 제공하는 것이 전자상거래 분야에서 일반화 되고 있다. 그러나 해당정보의 임의적 보관은 거래의 간편화에 도움이 되는 반면 외부 유출로 인해 직접적 혹은 간접적 피해가 발생할 수 있는 가능성을 높인다. 본 연구는 시스템 운영 기업의 측면에서 정보유출 사고발생의 위험률과 이로 인해 발생할 수 있는 기대 손실을 분석하기 위해 정보보호 관리체계로 대표되는 정성적 정보보호 관리방식과 더불어 대표적인 정량적 분석 방법인 개인정보에 대한 수요공급 곡선과 Gordon and Loeb 모델을 소개한다. 또한 한국인터넷진흥원에서 실시한 개인정보보호 수준 실태조사 결과 중 개인정보 누출사고가 있었던 조사 대상 사업자의 분포가 핵심사업분야나 기업규모에 따라 큰 편차를 나타내는 원인을 제시하였다. 이를 통해 징벌적 손해배상으로 유출사고로 인한 기업의 금전적 손실이 일정 수준을 유지하는 것과 법률로 요구하는 개인정보보호 기준을 최상위등급으로 유지하는 것이 기업간 개인정보 취약점의 편차를 보완할 수 있는 방법으로 제시된다.

• 한국전자통신학회논문지
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• 제8권2호
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• pp.291-299
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• 2013

본 연구는 제5차 청소년건강행태 온라인조사 자료를 활용해 청소년의 인터넷 중독에 영향을 미치는 요인을 인구사회학적 특성 요인, 건강 요인, 일탈행동 요인을 중심으로 탐색하였다. 이를 위해 본 연구에서는 첫째, 독립변인인 인구사회학적 특성 요인, 건강 요인, 일탈행동 요인과 종속변인인 인터넷 중독 수준을 빈도분석, 백분율, 평균 등의 기술 통계분석을 통해 파악하였으며, 둘째, 각 독립변인의 하위집단별 인터넷 중독 수준의 차이를 카이자승 검증을 통해 비교분석하였으며, 셋째, 각 독립변인들이 인터넷 중독에 미치는 영향을 로지스틱회귀분석을 통해 파악하였다. 연구결과를 로지스틱 회귀분석에 의해 제시하면, 인구사회학적 특성 요인에서는 남학생인 경우에, 양부모와 동거하지 않는 경우에, 가계의 경제수준이 낮은 경우에, 학업성적이 낮은 경우에, 건강 요인에 있어서는 주관적으로 건강하지 못하다고 느끼는 경우에, 주관적으로 행복하지 못하다고 느끼는 경우에, 스트레스정도가 높은 경우에, 우울을 경험한 경우에, 일탈행동 요인에서는 약물사용 경험이 있는 경우에 그렇지 않은 경우에 비해 통계학적으로 유의한 수준에서 높은 인터넷 중독을 가능성을 보이는 것으로 나타났다. 본 연구에서는 이상의 결과를 토대로 청소년의 인터넷 중독 대응방안에 대해 논의하였다.

• Clinical and Experimental Pediatrics
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• 제59권2호
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• pp.54-58
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• 2016

Purpose: We evaluated the characteristics of patients with Kawasaki disease (KD) who presented with only fever and cervical lymphadenopathy on admission, and compared them with the characteristics of those who presented with typical features but no cervical lymphadenopathy. Methods: We enrolled 98 patients diagnosed with KD. Thirteen patients had only fever and cervical lymphadenopathy on the day of admission (group 1), 31 had typical features with cervical lymphadenopathy (group 2), and 54 had typical features without cervical lymphadenopathy (group 3). Results: The mean age ($4.3{\pm}2.1$ years) and duration of fever ($7.5{\pm}3.6$ days) before the first intravenous immunoglobulin (IVIG) administration were highest in group 1 (P=0.001). Moreover, this group showed higher white blood cell and neutrophil counts, and lower lymphocyte counts after the first IVIG administration as compared to the other groups (P =0.001, P =0.001, and P =0.003, respectively). Group 1 also had a longer duration of hospitalization and higher frequency of second-line treatment as compared to groups 2 and 3 (group 1 vs. group 2, P =0.000 and P =0.024; group 1 vs. group 3, P =0.000 and P =0.007). A coronary artery z score of >2.5 was frequently observed in group 1 than in group 3 (P = 0.008). Conclusion: KD should be suspected in children who are unresponsive to antibiotics and have prolonged fever and cervical lymphadenopathy, which indicates that KD is associated with the likelihood of requiring second-line treatment and risk of developing coronary artery dilatation.

• 대한세포병리학회지
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• 제10권1호
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• pp.1-5
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• 1999

To evaluate whether different qualifications of a cytologic diagnosis of "atypical squamous cells of undetermined significance(ASCUS)" predict a greater or lesser likelihood of tissue diagnosis of uterine cervix, we compared different cytologic qualifications of ASCUS with the tissue diagnosis. One hundred twenty-two consecutive Papanicolaou smears showing ASCUS in women who had undergone cervical biopsy within nearest 30 days were collected. The 122 smears were qualified as "favor reactive"(25%), "favor low grade squamous intraepithelial lesion (LSIL)"(24%), "favor squamous intraepithelial lesion(SIL)"(16%), "favor high grade squamous intraepithelial lesion(HSIL)"(16%), and "not otherwise specified"(19%). Squamous intraepithelial or invasive lesion was pathologically confirmed by cervical biopsy in 13%, of the "favor reactive", 27% in "favor LSIL", 70% in "favor SIL", 75%, in "favor HSIL", and 35% in "not otherwise specified" smears. There were significant associations between the favor reactive smear and the benign biopsy finding and between the favor SIL smear and the biopsy shewing a squamous intraepithelial or more severe lesion. Nevertheless, most of favor LSIL smears exhibit reactive process in tissue biopsy. Conclusively, qualified ASCUS stratifies women Into different risk groups for SIL. The cytopathologist should make the cytologic diagnosis of "ASCUS, favor LSIL" circumspectly.

• 상하수도학회지
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• 제34권4호
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• pp.251-258
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• 2020

Sewer deterioration models are needed to forecast the remaining life expectancy of sewer networks by assessing their conditions. In this study, the serious defect (or condition state 3) occurrence probability, at which sewer rehabilitation program should be implemented, was evaluated using four probability distribution functions such as normal, lognormal, exponential, and Weibull distribution. A sample of 252 km of CCTV-inspected sewer pipe data in city Z was collected in the first place. Then the effective data (284 sewer sections of 8.15 km) with reliable information were extracted and classified into 3 groups considering the sub-catchment area, sewer material, and sewer pipe size. Anderson-Darling test was conducted to select the most fitted probability distribution of sewer defect occurrence as Weibull distribution. The shape parameters (β) and scale parameters (η) of Weibull distribution were estimated from the data set of 3 classified groups, including standard errors, 95% confidence intervals, and log-likelihood values. The plot of probability density function and cumulative distribution function were obtained using the estimated parameter values, which could be used to indicate the quantitative level of risk on occurrence of CS3. It was estimated that sewer data group 1, group 2, and group 3 has CS3 occurrence probability exceeding 50% at 13th-year, 11th-year, and 16th-year after the installation, respectively. For every data groups, the time exceeding the CS3 occurrence probability of 90% was also predicted to be 27th- to 30th-year after the installation.

• 한국식품위생안전성학회지
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• 제26권4호
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• pp.302-307
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• 2011

One of the most important objectives of post-marketing monitoring of dietary supplements is the early detection of unknown and unexpected adverse events (AEs). Several causality algorithms, such as the Naranjo scale, the RUCAM scale, and the M & V scale are available for the estimation of the likelihood of causation between a product and an AE. Based on the existing algorithms, the Korea Food & Drug Administration has developed a new algorithm tool to reflect the characteristics of dietary supplements in the causality analysis. However, additional work will be required to confirm if the newly developed algorithm tool has reasonable sensitivity and not to generate an unacceptable number of false positives signals.

• Journal of the Korean Data and Information Science Society
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• 제28권6호
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• pp.1415-1425
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• 2017

태풍은 강한 바람과 폭우를 동반하며 매년 한반도에 인명과 재산피해의 원인이 된다. 국내에서 발생한 자연재해 피해에서 태풍이 차지하는 비중이 높다. 태풍의 많은 피해는 폭우에 의해 발생하므로 태풍이 일 최대강수량에 미치는 영향을 정량적으로 살펴볼 필요가 있다. 일 최대강수량은 극치자료로 일반적으로 일반화극단치분포를 따른다. 연구자료로 1976년부터 2016년까지 한반도에 설치된 60개 종관기상관측장비에서 수집된 일강수량, 최대풍속, 평균풍속 자료가 사용되었다. 태풍이 온 기간을 제외한 일강우량 자료와 태풍이 온 기간을 포함한 일강우량 자료로 구분하여 일반화극단치모형에 적합시켰다. 모수추정방법으로 최우추정법과 L-적률추정법이 이용되었다. K-S검정과 $Cram{\acute{e}}r$ von Mises검정을 통해 모형의 적합도를 검정하였다. 추정된 모수를 기반으로 25년, 50년, 100년, 200년 재현수준을 계산하였다. 태풍기간 포함유무에 따른 재현수준을 비교한 결과 태풍은 강릉 인근의 동해안과 울산과 완도 인근의 남해안의 일 최대강수량에 영향을 미친다.