• Title/Summary/Keyword: Safety-related products

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Protectivity and safety following recombinant hepatitis B vaccine with different source of bulk compared to hepatitis B (Bio Farma) vaccine in Indonesia

  • Yetty M. Nency;Farid Agung Rahmadi;Mulyono;Dimas Tri Anantyo;Nur Farhanah;Rebriarina Hapsari;Helmia Farida;Udadi Sadhana;Herry Djagat;Tri Nur Kristina;Achmad Zulfa Juniarto;Mita Puspita;Rini Mulia Sari;Novilia Sjafri Bachtiar
    • Clinical and Experimental Vaccine Research
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    • v.11 no.1
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    • pp.43-52
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    • 2022
  • Purpose: Indonesia, a high populous and the second-highest country in epidemicity of hepatitis B in South-East Asia require maintaining its capacity of monovalent hepatitis B production to keep up with both the national immunization program and global needs. To keep the sustainability of the vaccine, a new bulk is needed to be made available. This study aims to evaluate the immunogenicity and safety of Bio Farma newly formulated recombinant hepatitis B vaccines, which came from different sources of bulk, compared to the already registered hepatitis B vaccine. Materials and Methods: An experimental, randomized, double-blind, cohort intervention phase II clinical trial was conducted on three recombinant hepatitis B vaccines from different bulk sources, with Bio Farma registered hepatitis B vaccine as the control group. A total of 536 participants around age 10 to 40 years old were thricely vaccinated with twice serological assessments. The subject's safety was monitored for 28 days after each vaccination. Results: Of 536 enrolled participants, 521 finished the vaccination and serology assessments. The investigational products were proven not to be inferior to the control. All vaccines were well tolerated. No differences in rates of local and systemic reactions were seen between the investigational products and control. No serious adverse event was found to be related to the investigational vaccines. Conclusion: Investigational vaccines are shown to be equally immunogenic and safe as the control vaccine.

The Effects of Hazardous Chemical Exposure on Cardiovascular Disease in Chemical Products Manufacturing Workers

  • Kim, Ki-Woong;Won, Yong Lim;Ko, Kyung Sun;Heo, Kyung-Hwa;Chung, Yong Hyun
    • Toxicological Research
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    • v.28 no.4
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    • pp.269-277
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    • 2012
  • The purpose of this study was to understand the mechanism of cardiovascular disease (CVD) caused by exposure to hazardous chemicals. We investigated changes in the symptoms of metabolic syndrome, which is strongly related to CVD, and in levels of other CVD risk factors, with a special emphasis on the roles of catecholamines and oxidative stress. The results revealed that neither body mass index (BMI) nor waist and hip circumferences were associated with exposure to hazardous chemicals. Among metabolic syndrome criteria, only HDL-cholesterol level increased on exposure to hazardous chemicals. Levels of epinephrine (EP) and norepinephrine (NEP) were not influenced by exposure to hazardous chemicals; however, the total antioxidative capacity (TAC) reduced because of increased oxidative stress. Both hazardous chemical exposure level and metabolite excretion were related to EP, NEP, and the oxidative stress index (OSI). Logistic regression analysis with these factors as independent variables and metabolic syndrome criteria as dependent variables revealed that EP was associated with blood pressure, and NEP with metabolic syndrome in the chemical-exposed group. In conclusion, the results suggest that reactive oxygen species generated and oxidative stress due to exposure to hazardous chemicals act as mediators and cause changes in the physiological levels of EP and NEP to increase blood pressure. This ultimately leads to the development of CVD through increase in cholesterol, triglyceride, and blood glucose levels by lipid peroxidation.

Oral Hygiene Knowledge and the Actual Condition of Oral Care for the Students in the Public Health and non-Public Health Departments (보건계열학과와 비보건계열학과 학생들의 구강위생지식 및 관리 실태)

  • Lee, Jong-Do;Shin, Du-Man;Park, Jong-Tack
    • Journal of Technologic Dentistry
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    • v.34 no.4
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    • pp.447-455
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    • 2012
  • Purpose: This study was to investigate oral hygiene knowledge and the actual condition of oral care for the students in the public health and non-public health Departments. Methods: The survey sample consisted of 262 randomly selected students. 197 of them are public health-related students and 65 are non-public health-related students. The questionnaires used in this study consisted of 4 items for general information, oral health status of 2 items, 5 items for Oral hygiene knowledge and actual condition of oral care of 5 items. Collected data were analyzed by Frequency Analysis t-test and Crosstabs using SPSS(Statistical Package for Social Sciences) Win 19.0 statistics program. Results: Regarding general characteristics of the subjects, there were 53.8% of first-year student, 26.0% of second-year student and 20.2% of third-year student among 52.3% of males and 47.7% of females. The subjects received less than "100,000" won(13.0%), "100,000-190,000" won (5.0%), "200,000-290,000" won(30.9%), "300,000-390,000" won (33.2%) and more than "400,000" won(17.9%) a month for an allowance. The subjects had 'none' (44.3%), '1'(6.5%), '2'(12.6%), '3'(5.0%), '4'(5.3%), 'more than' 5(0.8%) of dental caries and 'do not know' were 25.6%. The numbers of dental prosthetics were 'no' (35.5%), '1'(13.7%), '2'(17.2%), '3'(10.3%), '4'(11.5%), and 'more than 5'(11.8%). The public health students(84.8%) had a higher positive response rate than the non-public health students(66.2%). The public health students(80.2%) had a higher negative response rate than the non-public health students(78.5%) in the result of onset of gum disease pain awareness. The non-public health students(65.5%) had a higher negative response rate than the public health students(68.3%)) in the result of heredity of gum disease. The t-test showed that public health-related department students(M=8.264, SD=0.821) had more knowledge about oral hygiene than non-public health-related department students(M=8.015, SD=1.082). 'do not use' in the oral care products except toothpaste and toothbrush showed that public health-related department students(60.4%) use the products more than non-public health-related department students(66.2%). Conclusion: In this study, public health-related department students had higher oral hygiene knowledge and actual condition of oral care compared to non-public health-related students, but low in practical action. Due to the lower level of dental care products use in non-public health-related department, a continuous oral care education program is required.

Foodservice Management and Food Safety Knowledge and Practices of Employees in Elderly Welfare Facilities (50인 미만 노인복지시설의 급식 현황 및 급식업무 종사자들의 위생지식 및 실천도 평가)

  • Seo, Sunhee;Yun, Nara
    • Journal of the Korean Dietetic Association
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    • v.17 no.3
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    • pp.287-301
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    • 2011
  • This study examined the current status of foodservice management in elderly welfare facilities and evaluated food service workers' food safety practices and knowledge. For this, the directors of 20 elderly welfare facilities (each with fewer than 50 residents) located in Seoul were interviewed and a survey of 40 foodservice workers was conducted to determine their food safety knowledge and practices. The facilities accommodated an average of 28 residents. All the facilities were self-operated and approximately 62% were dependent on payments by residents. Only 15% had a dietitian in charge of menu planning, food purchasing, and food safety management. Approximately 50% had their facility managers take responsibilities for menu planning and food safety management. Most of the facilities provided food safety training within their own facility and sanitized their utensils, cutting boards, and dishcloths on a daily basis. A limited number of foodservice workers, insufficient training programs, and budget constraints were some of the major barriers to food safety management. Their average score on food safety practices was 1.62, and that on food safety knowledge was 17.6 out of 19 points. These results indicate that the foodservice workers had good food safety knowledge and appropriate food safety practices. There was a significant correlation only between food safety practices related to receiving and storing food products and knowledge of personal hygiene.

Investigation of Stresses Due to Various Parameters of Shell and Tube Oil Cooler (다관 원통식 오일 냉각기의 다양한 파라미터에 따른 스트레스 고찰)

  • Han, S.K.
    • Journal of Power System Engineering
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    • v.13 no.1
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    • pp.5-12
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    • 2009
  • The present work aims to estimate channel, shell, tube and tube sheet stresses of shell and tube oil cooler stemmed from various parameters. These parameters involve size, thickness and dimension of shell and tube oil cooler, including fluid temperature. The main purpose of the present work is to ensure safety of design products and also develop new products rapidly. For stress evaluation of oil coolers, first of all, the maximum pressure on the shell-side and on the tube side is fixed with 3.1MPa and 1.5MPa, respectively. Secondly, the pressure on each side varies from 2MPa to 3.1MPa on the shell side and tram 0.6MPa to 2MPa on the tube side. Various parameters under these conditions are employed to estimate design stresses on each side of oil cooler. These basic information related to stresses will be useful for a designer or manufacturer of an oil cooler.

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Wearable Wellness Sensors and Devices (WWSD): State of the Arts and Challenges (착용형 웰니스 센서 및 장치 관련 기술 응용 현황)

  • Ahn, Bummo
    • Journal of the Korean Society for Precision Engineering
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    • v.32 no.2
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    • pp.199-208
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    • 2015
  • The aim of this paper is to review recent developments and commercialized products in the field of wearable wellness sensors and devices (WWSD). Although there are several dedicated researches, the completed theories and systematic techniques have not been well established. Therefore, we divided the WWSD into four different topics (healthcare, safety & prevention, gaming & lifestyle, and sports & fitness), and review the state of the arts and challenges on the applications on the sensor and device technologies with particular focus on WWSD. We also review the limitations of the current technologies on the developments and commercialized products. Finally, we suggest and discuss new research topics related on the four topics of the WWSD.

Report on cases of misleading advertisements in the Korean oral hygiene products market (국내 구강위생용품 시장의 일부 허위·과장광고 실태 보고)

  • Jeon, Se-Jeong
    • Journal of Korean society of Dental Hygiene
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    • v.21 no.3
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    • pp.203-209
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    • 2021
  • The purpose of this study was to investigate the status of exaggerated advertisements in the Korean oral hygiene product market and to urge dental hygienists to play the role of experts. The exaggerated advertisements on the largest online shopping platform in Korea were investigated. Searches were performed with keywords related to oral hygiene, such as "bad breath" and "tartar", and product names of 1,000 products listed at the top were investigated to select the suspicious ones. The situation was found to be grave; for example, a mouthwash capable of preventing coronavirus disease, which lacks scientific evidence, and a self-tartar remover that did not guarantee safety or performance were being sold. Strict government supervision is required, and dental hygienists must be urged to play an active role as oral health experts.

Study on Japanese Consumers' Korean Food Consumption Behaviors and Market Segmentation Based on Food-related Lifestyle - Focusing on Inbound Japanese Tourists - (식생활라이프스타일에 따른 일본소비자 한식 소비행동 및 시장세분화 연구 - 방한 일본관광객을 대상으로 -)

  • Kim, Kyung-Hee
    • Journal of the Korean Society of Food Culture
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    • v.26 no.6
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    • pp.614-620
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    • 2011
  • This study attempted to identify differences in Korean food consumption behaviors between groups of Japanese consumers segmented in accordance to their food-related lifestyles. This study was performed to provide Korean food service companies basic information to implement a strategy for the globalization of Korean food. As a result of the empirical analysis, the food-related lifestyles of Japanese consumers were deduced to the following four factors: "health and safetyoriented lifestyle", "palate and safety-oriented lifestyle", "economic efficiency-oriented lifestyle", and "simplicity-oriented lifestyle". Further, as a result of the cluster analysis, food-related lifestyles were classified into the following three groups: "a group highly interested in food-related life", "an economic efficiency-oriented group", and "a simplicity-oriented group". Second, there were significant differences in demographic characteristics and the characteristics of Korean food consumption behaviors between the groups. Third, also in a comparison of satisfaction with and loyalty to Korean restaurants with crucial attributes during the selection of Korean food, there were significant differences between the groups. Therefore, it is necessary to develop various Korean food products that will cater to Japanese consumers in accordance with each segmented group.

Purchasing Behaviors and Needs for HMR according to the Food-Related Lifestyles of Baby Boomer Women (베이비부머 여성들의 식생활 라이프 스타일에 따른 HMR 구매행동 및 요구도)

  • Myung, Choonok;Nam, Haewon;Park, Youngsim
    • The Korean Journal of Food And Nutrition
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    • v.29 no.1
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    • pp.87-103
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    • 2016
  • The purpose of this study was to analyze the food-related lifestyle choices of female baby boomers and to investigate variables regarding home meal replacement (HMR) buying behaviors and future needs. This study was conducted on 358 female baby boomers 53 years of age living in Gyeonggi and near Seoul. Out of 420 distributed questionnaires, 358 were returned and used for analysis (response rate: 85.2%). As a result of cluster analysis, three groups were identified based on the food-related lifestyles : a value-seeking group, a convenience-seeking group, and a health-seeking group. Among the three groups, there were significant differences in two socio-demographic characteristics, education level (p<0.05) and regular exercise (p<0.01), and in several health- and food-related habits, type of breakfast (p<0.01), type of dinner (p<0.05), dinner details (p<0.05), frequency of eating out (p<0.05), and eating habits score (p<0.01). The health-seeking group was significantly more likely to purchase ready to cook (RTC) items (59.1%) than were the other groups (p<0.001). However, the ratio of HMR purchasing for the purpose of meal replacement (p<0.05) and an HMR purchasing frequency of more than twice a week (p<0.001) were significantly lower in the health-seeking group. Reasons for selecting HMR showed a similar tendency among groups in taste (26.2%), convenience (18.7%), price (16.9%), safety (15.3%) and type of food (14.3%). However, the satisfaction scores for hygiene and safety reported by the health-seeking group were significantly lower than those reported by the other groups. More than two-thirds of all respondents were willing to purchase HMR in the future, though there were significant differences according to group: convenience-seeking group, 73.1%, health-seeking group, 70.1%, and value-seeking group, 65.7% (p<0.05). Our results suggest that the number of baby boomers purchasing HMR products will continue to grow and baby boomers will want HMR products to be more healthy (52.0%), safe (28.5%) and delicious (13.4%). An emphasis on taste was high in the convenience-seeking group, whereas an emphasis on health was high in the health-seeking and value-seeking groups. In conclusion, this study shows various food-related lifestyles amongst female baby boomers and illustrates the need to develop HMR marketing strategies targeted to these different lifestyles.

Safety Management System on Nanomaterials with a Regulatory Scheme (나노물질 안전관리 동향 및 제도 도입에 관한 고찰)

  • Kim, Sunah;Kim, Hojung;Hong, Yongsuk
    • Journal of Environmental Policy
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    • v.12 no.3
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    • pp.49-71
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    • 2013
  • Nanomaterials, which have the issues related to toxicity, environmental exposures, and human health, have been focused on significance of their safety management. Regarding their higher applicability for multiple sectors from chemicals to consumer products, the most important thing is to consider international policy cases categorized by regulatory intensities, applicable sectors, and substance types for establishing of convincing safety management system on nanomaterials. For minimizing the nanomaterials' risk potential, developing the system that underlines a precautionary principle is also needed. Regulatory system on nanomaterials should be applicable to the status quo and be a proactive approach to rapidly changing international trends.

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