• Journal of Pharmaceutical Investigation
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• v.30 no.4
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• pp.299-307
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• 2000

생물학적 동등성 시험은 동일 성분을 동량 함유한 제제가 유사조건에서 투여되었을 경우 그 유효성분이 전신순환혈이나 작용부위에서 유용하게 되는 속도 및 양에 큰 차이가 없음을 입증하는 시험이다. 즉 이미 제조허가 되어 시판중인 의약품과 동일한 품목의 제조허가를 받기 위한 경우이거나 생체이용률이 동일함을 증명하기 위해 실시하는 시험이다. 우리 나라에서는 1989년 1월 1일 이후 허가된 전문의약품으로서 신약과 동일한 의약품, 패취제제, 제제개선을 통해 흡수율을 높이는 경우에 생물학적 동등성 시험을 하도록 의무화하고 있다. 미국 FDA는 1975년 6월 생체이용률, 생물학적 동등성에 관한 규제안을 발표하였고, 우리 나라에서도 1988년 10월에 생물학적 동등성 시험 기준을 제정하였다. 유럽에서는 1991년 12월 CPMP(Committee for Proprietary Medicinal Products)에 의해 최초로 "생체이용률 및 생물학적 동등성에 대한 가이드라인"이 채택되었다. 그후 전문가 회의를 거쳐 규정 전반에 관한 것과 일반적 항목에 대한 검토가 이루어져 최종 개정된 가이드라인이 만들어졌다. 현재 in vivo 생체 이용률을 비교하는 생물학적 동등성 시험의 중요성이 증대되고 있고, 국제적으로도 각 국가별 생물학적 동등성 시험의 평가방법이나 기준설정에 대한 연구가 다양하게 이루어지고 있다. 또한 ICH에서도 생물학적 동등성 시험의 국제적 조화를 위한 시도가 이루어지고 있다. 우리 나라의 현행 생물학적 동등성 기준은 1998년 개정된 것을 사용하고 있으나 국제적 발전 추세에 맞추어 기준의 제고를 모색하고 있다. 그 일환으로 유럽의 "의약품의 생체이용률 및 생물학적 동등성 시험 가이드라인"을 소개하고자 한다., globunlin II의 두 component로 분리(分離)되었고 oryzenin은 시료(試料) 육우(陸羽) 132호(號), 등판(藤坂) 5호(號), 관산(關山) 재건(再建)에서는 oryzenin I, oryzenin II, oryzenin III의 3 component를 분리(分離)하였고 팔달(八達), 진흥(振興), 서광(瑞光), 은방주(銀坊主), 다마금(多摩錦), Pin Galw56의 6시료(試料)에서는 oryzenin II, oryzenin III의 2 component만 분리(分離)하였다. 3. 각(各) fraction을 여지전기영동(濾紙電氣泳動)하여 각(各) component의 농도곡선(濃度曲線)에 의해 함량(含量)을 구(求)한 결과(結果) albumin 0.26%, globulin I, 0.35%, globulin II, 0.32%, prolamin, 0.41%, oryzenin I, 0.30%, oryzenin II, 2.23%, oryzenin III, 2.66%이었다.미국의 경우 3일 이내 전화나 FAX로 보고하고, 10일이내 문서로써 보고하도록 되어 있다. 이러한 임상적 안전성 자료 관리에 대한 신속 보고 정의 및 기준에 대해서는 ICH에서도 논의가 되어 Step 4까지 다다르고 있으므로 앞으로 각 국에서의 적용만 남아있는 상태이고 보면 신약의 개발과 더불어 임상시험에서의 부작용등의 안전성 자료 관리에 대한 중요성은 더욱 강조될 것이다.공하는 음식의 섭취정도에도 영향을 주고 있으므로 학생들에게 학부모와 전담교사 및 학교영양사는 학생들에게 이상적인 아침식사에 대한 교육은 물론이고 아침식사를 실천할 수 있도록 다양한 방안에 대해 함께 연구해야 하겠다. 정부차원에서 학교급식에 아침식사 프로그램을 도입할

• Journal of The Korean Society of Inherited Metabolic disease
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• v.19 no.1
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• pp.20-25
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• 2019

Very-long-chain acyl-CoA dehydrogenase (VLCAD) deficiency (OMIM#201475) is an autosomal recessively inherited metabolic disorder of mitochondrial long-chain fatty acid oxidation. The clinical features of VLCAD deficiency is classified by three clinical forms according to the severity. Here, we report a case of later-onset episodic myopathic form of VLCAD deficiency whose diagnosis was confirmed by plasma acylcarnitine analysis and" multigene panel multigene panel sequencing. A 34-year old female patient visited genetics clinic for genetic evaluation for history of recurrent myopathy with intermittent rhabdomyolysis. She suffered first episode of rhabdomyolysis with acute renal failure requiring hemodialysis at twelve years old. After then, she suffered several times of recurrent rhabdomyolysis provoked by prolonged exercise or fasting. Physical and neurologic exam was normal. Serum AST/ALT and creatinine kinase (CK) levels were mildly elevated. However, according to her previous medical records, her AST/ALT, CK were highly elevated when she had rhabdomyolysis. In suspicion of fatty acid oxidation disorder, multigene panel sequencing and plasma acylcarnitine analysis were performed in non-fasting, asymptomatic condition for the differential diagnosis. Plasma acylcarnitine analysis revealed elevated levels of C14:1 ($1.453{\mu}mol/L$; reference, 0.044-0.285), and C14:2 ($0.323{\mu}mol/L$; 0.032-0.301) and upper normal level of C14 ($0.841{\mu}mol/L$; 0.065 -0.920). Two heterozygous mutation in ACADVL were detected by multigene panel sequencing and confirmed by Sanger sequencing: c.[1202G>A(;) 1349G>A] (p.[(Ser 401Asn)(;)(Arg450His)]). Diagnosis of VLCAD deficiency was confirmed and frequent meal with low-fat diet was educated for preventing acute metabolic derangement. Fatty acid oxidation disorders have diagnostic challenges due to their intermittent clinical and laboratorial presentations, especially in milder late-onset forms. We suggest that multigene panel sequencing could be a useful diagnostic tool for the genetically and clinically heterogeneous fatty acid oxidation disorders.

• Korean Journal of Community Nutrition
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• v.27 no.2
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• pp.121-131
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• 2022

Objectives: This study aimed to examine the effectiveness of the intervention of the nutrition support team (NST) on the nutritional status of critically ill patients. Methods: The medical records of 176 adult patients who were admitted to the intensive care unit and received enteral or parenteral nutrition for more than 7 days were retrospectively analyzed. The patients were classified into the NST and non-NST groups according to whether they were referred to the NST or not. The NST group was further classified into the compliance and non-compliance groups depending on their compliance with the NST recommendations. Results: The NST referral rate was 56.8%, and the rate of compliance with the NST recommendations was 47.0%. Significantly higher energy and protein were provided to the NST and the compliance groups than to the non-NST and the non-compliance groups. The proportion of patients who reached the target calories after the initiation of enteral nutrition was significantly higher in the NST and the compliance groups than in the non-NST and the non-compliance groups. The serum albumin and hemoglobin levels significantly decreased in every group, but the changes were significantly lower in the compliance group. The nutritional status at discharge from the intensive care unit compared to the status at admission was significantly worse in the NST, non-NST, and non-compliance groups. However, the status was maintained in the compliance group. The length of stay in the intensive care unit was significantly shorter in the compliance group. Conclusions: Compliance with the NST recommendations was found to provide more calories and protein and prevent the deterioration of the nutritional status of critically ill patients. Therefore, effective communication between medical staff and the NST from the early stages of admission to the intensive care unit is needed to improve referrals to the NST and compliance with the recommendations.

• Journal of the Korean Society for information Management
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• v.40 no.3
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• pp.25-54
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• 2023

At a time when open data receives attention as an international trend, there is a need to discuss the role of international journals in Korea to support data sharing. Based on surveys and interviews of editors from the international journals, we identified factors affecting the policy adoption and examined the journal editors' perception on the adoption and components of the data sharing policy. As a result, scholarly journals that have adopted or are planning to adopt policies have recognized that data sharing is an international trend and can contribute to research development, but they stressed that efforts to improve the perception of data sharing were still necessary. Educational activities and compensation for sharing data were needed at scholarly journals' and communities' level. Also, components perceived important and selected by more than half of the editors as mandatory were 'data availability statement', 'data sharing level', 'data sharing method', and 'data citation'. While scholarly journals do not always need to mandate data sharing, it was necessary to mention conditions where data cannot be shared through data availability statements. The role of the organization developing and operating a repository appropriate for situations in Korea was also emphasized. In addition, by identifying factors affecting the policy adoption, significant differences were found in Journal Impact Factor quartiles, publication type, and subject area. This finding indicated that journals with a high impact factor are likely to have resources to support data sharing, and open access or hybrid journals are likely to have interest in open data as a part of open science. In the medical research area, active movements for data sharing in academic communities have promoted the adoption of data sharing policies. This study would be used as basic data to facilitate the adopton and operation of scholarly journals' data sharing policies in Korea.

• The Journal of the Convergence on Culture Technology
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• v.9 no.3
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• pp.137-143
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• 2023

This study was conducted to analyze factors affecting the length of stay in children with injuries by determining relationships between length of stay and characteristics of children(aged 0 to 12) with injuries. 7,804 patients aged 0 to 12 who participated in the Korea Nation Hospital Discharge In-Depth Injury Surveys, got a diagnosis of sequelae of injuries and of other consequences of external causes(S00-T98), and were discharged between 1 January 2016 and 31 December 2020 were investigated. A frequency analysis, independent samples t-test, and ANOVA were performed. Also, to identify factors affecting the length of stay, a regression analysis was performed. The average length of stay for the patients investigated in this study was 5.5 days. The length of stay for school-age children(aged 7 to 12) and children who had either public or private coverage was higher than that for preschoolers(aged 0 to 6) and children who didn't have public or private coverage, respectively. The length of stay for children admitted to a hospital in a rural area(Jeolla-do or Gyeongsang-do) was higher than that for children admitted to a hospital in a metropolitan area and the length of stay for children admitted to a hospital that had 100-299 hospital beds was relatively long. However, children who first visited a hospital for outpatient care stayed relatively short in hospital and children who had been burned or injured in traffic crashes stayed relatively long in hospital. Children who got a secondary diagnosis and had a principal procedure or who died after being discharged were in hospital for a long time. The findings of this study shall be useful, as they identified characteristics related to the length of stay for Korean children with injuries and factors that determine the length of stay for those children by analyzing the national dataset, or more specifically, the data from the Korea National Hospital Discharge In-Depth Injury Surveys. The risk of child injuries can be easily reduced by taking actions to prevent them and providing safety education programs. The present study has provided essential baseline data for the provision of aggressive care for child injuries and the establishment of a range of policies for child injury prevention.

• Tuberculosis and Respiratory Diseases
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• v.66 no.3
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• pp.192-197
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• 2009

Background: Despite the benefits of home oxygen therapy in patients suffering chronic respiratory failure, previous reports in Korea revealed lower compliance to oxygen therapy and a shorter time for oxygen use than expected. However, these papers were published before oxygen therapy was covered by the national insurance system. Therefore, this study examined whether there were some changes in compliance, using time and other clinical features of home oxygen therapy after insurance coverage. Methods: This study reviewed the medical records of patients prescribed home oxygen therapy in our hospital from November 1, 2006 to September 31, 2008. The patients were interviewed either in person or by telephone to obtain information related to oxygen therapy. Results: During study period, a total 105 patients started home oxygen therapy. The mean age was 69 and 60 (57%) were male. The mean oxygen partial pressure in the arterial blood was 54.5 mmHg and oxygen saturation was 86.3%. Primary diseases that caused hypoxemia were COPD (n=64), lung cancer (n=14), Tb destroyed lung (n=12) and others. After oxygen therapy, more than 50% of patients experienced relief of their subjective dyspnea. The mean daily use of oxygen was 9.8${\pm}$7.3 hours and oxygen was not used during activity outside of their home (mean time, 5.4${\pm}$3.7 hours). Twenty four patients (36%) stopped using oxygen voluntarily 7${\pm}$4.7 months after being prescribed oxygen and showed a less severe pulmonary and right heart function. The causes of stopping were subjective symptom relief (n=11), inconvenience (n=6) and others (7). Conclusion: The prescription of home oxygen has increased since national insurance started to cover home oxygen therapy. However, the mean time for using oxygen is still shorter than expected. During activity of outside their home, patients could not use oxygen due to the absence of portable oxygen. Overall, continuous education to change the misunderstandings about oxygen therapy, more economic support from national insurance and coverage for portable oxygen are needed to extend the oxygen use time and maintain oxygen usage.

• Journal of Oral Medicine and Pain
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• v.30 no.2
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• pp.163-199
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• 2005

Dentistry had been considered to be a relatively safe zone from the risk of medical accidents for there are less number of emergency cases. However, in these days, the number of medical dispute is increasing that the dentists would not be able to overlook it as if it is none of their matters. Hence, researches on various medical accidents and analyses on related matters to seek proper management have been carried out recently, but the datas are not enough yet. This study analysed the actual conditions of medical accidents as well as disputes and the general awareness of dental practitioners in local clinics with the purpose of understanding the general situation and to suggest counterplan. The study was conducted by analysing 1,882 questionnaires collected from total of 3,684 dentists belonging to Seoul Dental Association and where Doctors and Hospitals Medical Malpractice Insurance for dentists is administered. The results were as follows: 1. 98.47% of the respondents doubted the risk of medical accident and dispute. 2. 27.42% of the respondents experienced medical dispute, and there was no significant difference between the rate of medical disputes and the resident training. 3. Among the cases of medical accidents, those related to the periodontal/operative treatment showed the highest rate of 20.50%, and that related to implant treatment was 6.17%. 4. 43.02% of the respondents explained about the treatment procedure before the treatment while 25.90% started the treatment without consent of the patients. 5. Medical dispute resulted from not having any explanation or consent of the patients were of 16.55%. 10.26% had difficulties in solving the problem for missing the medical records. 6. 49.73% responded to be capable of administering first aid treatment. Among them, 23.60% were equipped with accurate knowledge regarding the emergency care. 7. During medical dispute, 88.09% sought counsel from other dentists, and Local district dental association was found to be the most frequently asked group. 8. In cases of medical dispute, 5.26% of the respondents were asked to submit relevant data from customer protection organization, and among them, 75.61% acceded the demand sincerely. 9. After the settlement of the dispute, 83.63% recovered relatively stable state of mind. 10. 99.46% of the respondents felt the necessity of medical dispute management organization, and 78.58% responded that it was urgent. 11. 66.70% of the respondents joined Doctors and Hospitals Medical Malpractice Insurance, although they had not experienced medical dispute. However, 73.36% of the respondent were not aware of it, and 93.36% of the members were not aware of the procedure of the dispute settlement. 12. 79.0% of the respondents who joined the Doctors and Hospitals Medical Malpractice Insurance still felt confused when medical dispute occured, but relatively safer than before. 13. When medical dispute was settled through Doctors and Hospitals Medical Malpractice Insurance, 71.92% of the dentists were contented more than moderately, however, 35.16% of the patients were contented. 14. For complement of Doctors and Hospitals Medical Malpractice Insurance, 53.22% of the respondents felt that insurance company, dentist, and patient should all participate in bringing mutual agreement for quick settlement of the dispute. In addition, 29.08% of the respondents wanted insurance company to prevent patients from disturbing their practices. From the above results, improvement of the general awareness on increasing rate of medical disputes, and education as well as complementary measures for settlement of the disputes are required.

• Journal of Preventive Medicine and Public Health
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• v.30 no.2 s.57
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• pp.381-391
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• 1997

In an epidemiological study of metal workers exposed to metalworking fluids (MWF), the prevalence time of Evolution, seasonal occurrence and clinical type of contact dermatitis were investigated. Compostional analysis of MWF with HPLC, dermatological examination and two consecutive questionnaire surveys were conducted. Study population was divided into two groups ; workers contact to cutting oil and workers contact to rust preventive oil. In the analysis of MWF, aliphatic hydrocarbons, having 12-20 carbons, was most common composition(49.04%) of cutting oil otherwise, major contents (90.99%) of the rust preventives oil were aliphatic hydrocarbons composed of 6-9 carbons. The frequency (point prevalence) of contact dermatitis(CD) was 7(12.7 per 100 subjects) in the dermatological examination of 55 workers. As the result of second survey for contact dermatitis, cumulative prevalence of oil working full-time and recent 1 year prevalence in two groups were 28.0, 16.7 and 15.1, 12.5 per 100 subjects. There were no difference in the prevalence of CD by oil, age, oil contact duration. Summer is the most common evolution season in workers exposed to cutting oil, but not in workers exposed to rust preventive oil. Major clinical type of CD was erythematous papules in both groups. It presents the importance of preventive measures that 51.1% suffer from contact dermatitis had medical care at their own expense, and 47.1% of them felt serious about their contact dermatitis. From the fact that 68.6% think cotton gloves protective apparatus, we emphasize the need for health education.

• Journal of Food Hygiene and Safety
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• v.32 no.2
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• pp.123-128
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• 2017

The purpose of this study was to determine the sodium (Na) and potassium (K) content of seasonal foods Four hundred food samples classified into 8 different kinds of seasonal foods were collected from 150 restaurants located in Seoul. The Na and K content in seasonal foods were the analyzed by ICP-OES. The Average content of Na and K in spicy seafood noodle soup were highest as $391.4{\pm}72.7mg$/100 g and $88.6{\pm}21.4mg$/100 g, respectly, while average content of Na was lowest in spicy buckwheat noodles as $255.3{\pm}67.0mg$/ 100 g and the average content of K was lowest in Udon as $36.3{\pm}17.8mg$/ 100 g, respectively. The Na/K ratio of spicy buckwheat noodles was $3.2{\pm}1.0$, while those of cold buckwheat noodles, fish cake, Udon were very high as measured more than 8. Among the seasonal foods, the average content of Na was highest in Winter group as $366.9{\pm}81.8mg$/ 100 g and the average content of K was highest in Autumn group as $84.8{\pm}24.1mg$/ 100 g. The ratio of Na/K was lowest in Summer group as $5.9{\pm}3.3$.

• Health Policy and Management
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• v.10 no.3
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• pp.19-49
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• 2000

This study was conducted to help staff members of health centers manage personnel by examining the staff members' recognition level of organization structure of health centers, their motivation, their job satisfaction level and its related factors. Data were collected from 471 staff members of 14 health centers from March 3, 1999 to April 30, 1999. The results of this study are summarized as follows. In recognition levels of organization structure of health centers, the recognition level of necessity of discretion right was highest(3.55 points on the base of 5 points), while the recognition level of the location of decision making right was lowest(2.77 points). The general recognition of organization structure of health centers was 3.06 points, the suitability of division of duties was 3.05 points, and the optimum of manpower and budget was 2.93 points. The staff members' general recognition level of the organization structure appeared significantly higher in case of the groups of small and medium sized cities, above fifties, below high school graduate, above the sixth grade, public service experience of above 20 years, service period of below 2 years at present post, and average monthly salary of one million, eight hundred and ten thousand won. In the recognition level of the location of decision making right, the groups of big cities, male, the married, above the sixth grade, health and administration posts, average monthly salary of one million, three hundred and ten thousand won to one million, and eight hundred thousand won were significantly higher than the other groups. The recognition level of necessity of discretion right was higher in case of the groups of the twenties, the unmarried, above college graduate, nursing post, public service experience of below 5 years, service period of below 2 years at present post, and average monthly salary of below eight hundred thousand won. In the recognition level of suitability of division of duties, the groups of small and medium sized cities, the married, medical technicians, public service experience of above 20 years, and service period of below 4 years at present post were significantly higher than the other groups. In the staff members' recognition levels of organization management, the recognition level of opinion response when making decision was highest(2.92 points). The recognition level of rationality of the target amount establishment method was 2.88 points and the recognition level of personnel management was 2.63 points. The recognition level of personnel management was significantly higher in case of the groups of small and medium sized cities, the forties, above the sixth grade, medical technicians, public service experience of above 20 years, service period of below 2 years at present post, and average monthly salary of above one million, eight hundred and ten thousand won. In the recognition level of opinion response when making decision, the groups of small and medium sized cities, female, the eighth grade, health and administration posts, and service period of below 2 years at present post were higher than the other groups. The recognition level of rationality of the target amount establishment method was significantly higher in case of the groups of above fifties, below high school graduate, above the sixth grade, medical service post, and public service experience of 15 to 20 years. The factors significantly influencing sanitation were sex, education level, the period of public service experience, general recognition of organization structure, recognition of necessity of discretion right, recognition of suitability of division of duties, and recognition of opinion response when making decision. The factors which significantly influenced motivation were marital status, grade, recognition of the location of decision making right, recognition of necessity of discretion right, recognition of division of duties, recognition of opinion response when making decision, and sanitation. Sex, education level, recognition of suitability of division of duties, recognition of the target amount establishment method, and motivation influenced job satisfaction significantly. The factors significantly influencing organization culture were age, the period of public service experience, service period at present post, recognition of optimum of manpower and budget, recognition of suitability of division of duties, recognition of opinion response when making decision, and recognition of rationality of the target amount establishment method. In the coming days, the staff members' job satisfaction level must be increased through motivation and efficient conduct of duty must be accomplished through rational organization structure and management. Moreover, change of the staff members' consciousness and administrative system which are suitable for local autonomy system have to be established with increase of local residents' consciousness level and education level. Forming organization culture by reformative idea which fits the new era, public health service by the Community Health Act and health education service by the Health Promotion Act must be carried out efficiently. In doing so, financial support of central government and active efforts and concerns of local governments have to be devoted in order to get public health service in which peculiarity of the community is considered to be pursued well.