• Title/Summary/Keyword: Drug safety data

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Development and Validation of Predictive Model for Salmonella Growth in Unpasteurized Liquid Eggs

  • Kim, Young-Jo;Moon, Hye-Jin;Lee, Soo-Kyoung;Song, Bo-Ra;Lim, Jong-Soo;Heo, Eun-Jeong;Park, Hyun-Jung;Wee, Sung-Hwan;Moon, Jin-San
    • Food Science of Animal Resources
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    • v.38 no.3
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    • pp.442-450
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    • 2018
  • Liquid egg products can be contaminated with Salmonella spp. during processing. A predictive model for the growth of Salmonella spp. in unpasteurized liquid eggs was developed and validated. Liquid whole egg, liquid yolk, and liquid egg white samples were prepared and inoculated with Salmonella mixture (approximately 3 Log CFU/mL) containing five serovars (S. Bareilly, S. Richmond, S. Typhimurium monophasic, S. Enteritidis, and S. Gallinarum). Salmonella growth data at isothermal temperatures (5, 10, 15, 20, 25, 30, 35, and $40^{\circ}C$) was collected by 960 h. The population of Salmonella in liquid whole egg and egg yolk increased at above $10^{\circ}C$, while Salmonella in egg white did not proliferate at all temperature. These results demonstrate that there is a difference in the growth of Salmonella depending on the types of liquid eggs (egg yolk, egg white, liquid whole egg) and storage temperature. To fit the growth data of Salmonella in liquid whole egg and egg yolk, Baranyi model was used as the primary model and the maximum growth rate and lag phase duration for each temperature were determined. A secondary model was developed with maximum growth rate as a function of temperature. The model performance measures, bias factor ($B_f$, 0.96-0.99) and $r^2$ (0.96-0.99) indicated good fit for both primary and secondary models. In conclusion, it is thought that the growth model can be used usefully to predict Salmonella spp. growth in various types of unpasteurized liquid eggs when those are exposed to various temperature and time conditions during the processing.

Evaluation of the food safety training for food handlers in restaurant operations

  • Park, Sung-Hee;Kwak, Tong-Kyung;Chang, Hye-Ja
    • Nutrition Research and Practice
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    • v.4 no.1
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    • pp.58-68
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    • 2010
  • This study examined the extent of improvement of food safety knowledge and practices of employee through food safety training. Employee knowledge and practice for food safety were evaluated before and after the food safety training program. The training program and questionnaires for evaluating employee knowledge and practices concerning food safety, and a checklist for determining food safety performance of restaurants were developed. Data were analyzed using the SPSS program. Twelve restaurants participated in this study. We split them into two groups: the intervention group with training, and the control group without food safety training. Employee knowledge of the intervention group also showed a significant improvement in their score, increasing from 49.3 before the training to 66.6 after training. But in terms of employee practices and the sanitation performance, there were no significant increases after the training. From these results, we recommended that the more job-specific and hand-on training materials for restaurant employees should be developed and more continuous implementation of the food safety training and integration of employee appraisal program with the outcome of safety training were needed.

Medication Error Management Climate and Perception for System Use according to Construction of Medication Error Prevention System (환자안전 관리자가 인식한 투약오류예방 시스템 구축실태에 따른 투약오류관리풍토 및 활용인식)

  • Kim, Myoung-Soo
    • Journal of Korean Academy of Nursing
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    • v.42 no.4
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    • pp.568-578
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    • 2012
  • Purpose: The purpose of this cross-sectional study was to examine current status of IT-based medication error prevention system construction and the relationships among system construction, medication error management climate and perception for system use. Methods: The participants were 124 patient safety chief managers working for 124 hospitals with over 300 beds in Korea. The characteristics of the participants, construction status and perception of systems (electric pharmacopoeia, electric drug dosage calculation system, computer-based patient safety reporting and bar-code system) and medication error management climate were measured in this study. The data were collected between June and August 2011. Descriptive statistics, partial Pearson correlation and MANCOVA were used for data analysis. Results: Electric pharmacopoeia were constructed in 67.7% of participating hospitals, computer-based patient safety reporting systems were constructed in 50.8%, electric drug dosage calculation systems were in use in 32.3%. Bar-code systems showed up the lowest construction rate at 16.1% of Korean hospitals. Higher rates of construction of IT-based medication error prevention systems resulted in greater safety and a more positive error management climate prevailed. Conclusion: The supportive strategies for improving perception for use of IT-based systems would add to system construction, and positive error management climate would be more easily promoted.

A Study on the Direction of Developing a Simulator for Performance Evaluation of Pulse Wave Detectors Through a Review of the Development Status of Cardiovascular Simulators (심혈관계 시뮬레이터 개발 동향 분석을 통한 맥파검사용기기 성능평가 시뮬레이터 연구개발 방향 모색)

  • Lee, Ju-Yeon;Kim, Jaeyoung;Go, Dong-Hyun;Lee, Ji-Won;Lee, Tae-Hee;Park, Chang-Won;Lee, Su-Kyoung
    • Journal of Biomedical Engineering Research
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    • v.43 no.3
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    • pp.136-146
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    • 2022
  • In this study, it is intended to provide basic data that can help develop a cardiovascular simulator for performance evaluation of pulse wave detectors by identifying the development status of domestic and overseas cardiovascular simulators. A total of 119 papers were selected by excluding duplicate literature, gray literature, and literature not related to a cardiovascular simulator. Based on the selected literature, the research trend of cardiovascular simulators was analyzed. As a result of analyzing the purpose of the study, most of the simulators were developed to evaluate the hemodynamic properties of artificial hearts and valves. In addition, it was used for simulation evaluation or hemodynamic studies such as pulse wave studies. As a result of analyzing configurations of the simulators, a heart most often consisted of only one left ventricle. For blood vessels, the Windkessel model was most often constructed using chambers and valves. In most studies, blood was reproduced by mixing glycerin and water to reproduce both density and viscosity. In addition, as a result of analysis from the perspective of medical device performance evaluation, simulators for evaluating artificial heart and artificial valves have been studied a lot, whereas simulators for blood pressure, pulse wave, and blood flow devices have been relatively insignificant. Based on the review results, we suggested considerations when developing a simulator for performance evaluations of a pulse wave detector.

Monitoring of Heavy Metals Migrated from Polylactide (PLA) Food Contact Materials in Korea (국내 유통 폴리락타이드(PLA) 식품용 기구 및 용기·포장의 중금속 이행량 모니터링)

  • Kim, Hyeonuk;Park, So-Yeon;Jo, Ye-Eun;Park, Yongchjun;Park, Se-Jong;Kim, Meehye
    • Journal of Food Hygiene and Safety
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    • v.33 no.2
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    • pp.102-109
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    • 2018
  • In the present study, a variety of polylactide (PLA) articles (n = 211) were tested for migration of lead (Pb), cadmium (Cd) and arsenic (As) into the food simulant (4% v/v acetic acid). Pb, Cd, and As were analyzed by inductively coupled plasma mass spectrometry (ICP-MS). Migration tests were performed at $70^{\circ}C$ and $100^{\circ}C$ for 30 min. The amounts of Pb, Cd, and As increased at $100^{\circ}C$ for 30 min compared with levels at $70^{\circ}C$. However, the migration at both conditions was very low. The maximum level of Pb at $100^{\circ}C$ for 30 min corresponded to 1% of the migration limit. The estimated daily intakes (EDI) based on safety evaluation ranged from $2.5{\times}10^{-5}$ to $2.0{\times}10^{-3}{\mu}g/kg\;bw/day$ for Pb, Cd, and As. The EDI calculated from migration of Pb at $100^{\circ}C$ for 30 min in PLA was the maximum value, $2.0{\times}10^{-3}{\mu}g/kg\;bw/day$, which corresponded to 0.055% of provisional tolerable weekly intake (PTWI, $25{\mu}g/kg\;bw/week$). The data from this study represent a valuable source for science-based safety control and management of hazardous heavy metals migrating from polylactide food contact materials.

The Case and Implications of Terminology Mapping for Development of Dankook University Hospital EHR-Based MOA CDM (단국대학교병원 EHR 기반 MOA CDM 구축을 위한 용어 매핑 사례와 시사점)

  • Yookyung Boo;Sihyun Song;Jihwan Park;Mi Jung Rho
    • Korea Journal of Hospital Management
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    • v.29 no.1
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    • pp.1-18
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    • 2024
  • Purposes: The Common Data Model(CDM) is very important for multi-institutional research. There are various domestic and international CDM construction cases to actively utilize it. In order to construct a CDM, different terms from each institution must be mapped to standard terms. Therefore, we intend to derive the importance and major issues of terminology mapping and propose a solution in CDM construction. Methodology/Approach: This study conducted terminology mapping between Electronic Health Record(EHR) and MOA CDM for constructing Medical Record Observation & Assessment for Drug Safety(MOA) CDM at Dankook University Hospital in 2022. In the process of terminology mapping, a CDM standard terminology process and method were developed and terminology mapping was performed by applying this. The constructions of CDM mapping terms proceeded in the order of diagnosis, drug, measurement, and treatment_procedure. Findings: We developed mapping guideline for CDM construction and used this for mapping. A total of 670,993 EHR data from Dankook University Hospital(January 1, 2013 to December 31, 2021) were mapped. In the case of diagnosis terminology, 19,413 were completely mapped. Drug terminology mapped 92.1% of 2,795. Measurement terminology mapped 94.5% of 7,254 cases. Treatment and procedure were mapped to 2,181 cases, which are the number of mapping targets. Practical Implications: This study found the importance of constructing MOA CDM for drug side effect monitoring and developed terminology mapping guideline. Our results would be useful for all future researchers who are conducting terminology mapping when constructing CDM.

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Current status and development direction of the food nutrition safety policy: The first phase of sugar intake reduction plan (식품영양안전 정책 현황 및 발전방향: 1차 당류 저감 종합계획을 중심으로)

  • Jung, Jin-Yee;Park, Sun-Young;Lee, Soon-Kyu
    • Korean Journal of Health Education and Promotion
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    • v.33 no.4
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    • pp.35-46
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    • 2016
  • Objectives: The purposes of this study are to refer existing and past domestic and foreign policies and to establish a comprehensive plan to reduce sugar consumption and utilize it as fundamental data to establish and implement relevant policies. Methods: Korean government analyzed domestic and foreign policies and average sugar intake to develop draft of sugar intake reduction plan. Based on the plan, objectives, sections and agendas of the plan were set after taking into account of their feasibility. Results: The policy has three directions: to help sugar intake reduction in all population groups, to create an environment which helps people to make informed decision on lower sugar choices and to lay scientific and statistical foundation for sugar intake reduction plan. The goal is to restrict average sugar intake from processed food to less than 10% of total energy intake per day. Three core strategies are to help reduce intakes of sugar in all population groups, to create an environment which helps people to make informed decision on lower sugar choices and to lay a foundation for sugar intake reduction plan. Each strategies has 2~4 projects. Conclusions: This study is expected to serve as a catalyst for carrying out the first phase of sugar intake reduction plan to help reduce sugar consumption.

Gliclazide compatibility with some common chemically reactive excipients; using different analytical techniques

  • Jabbari, Hamideh Najjarpour;Shabani, Mohammad;Monajjemzadeh, Farnaz
    • Analytical Science and Technology
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    • v.34 no.2
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    • pp.46-55
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    • 2021
  • Evaluation of drug-excipient compatibility is one of the basic steps in the preformulation of pharmaceutical dosage forms. Some reactive excipients have been known so far which may cause stability problems for drug molecules in pharmaceutical dosage forms. The aim of this study was to evaluate drugexcipient compatibility of gliclazide with some common pharmaceutical excipients, known for their ability to incorporate in drug-excipient interactions. Binary mixtures were prepared using lactose, magnesium stearate, polyvinylpyrrolidone, sodium starch glycolate, polyethylene glycol 2000 and dicalcium phosphate. Based on the results; gliclazide was incompatible with all tested excipients; but not with dicalcium phosphate. DSC (Differential Scanning Calorimetry) results were in accordance with HPLC (High Pressure liquid chromatography) data and were more predictive than FTIR (Fourier Transform Infrared Spectroscopy). Drug and reactive excipients incompatibility was fully discussed and documented. It is advisable to avoid incompatible excipients or carefully monitor the drug stability when incorporating such excipients in final formulation designs.

Development of Drug Exposure Registries on Pregnant Women (임부의 약물 노출 관련 등록지침 개발 연구)

  • Kim, Soo-Hee;Noh, Hye-Jin;Ji, Eun-Hee;Yoon, Jeong-Hyun;Kim, Kyung-Im;Shin, Wan-Gyoon;Oh, Jung-Mi
    • Korean Journal of Clinical Pharmacy
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    • v.20 no.2
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    • pp.114-119
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    • 2010
  • Objectives: We developed a registry guidance to provide a standard for data collection, analysis and methodical management of information on the influence of drug exposure on pregnant women and fetus. Methods: We surveyed guidances and regulations of clinical trials and the pharmaceutical affairs law, compared them with Pregnancy Exposure Registry of other countries and in addition, investigated related references. We found the flaws of the present registry and supplemented it based on better results from other countries. Results: We developed a concrete and detailed report that included pregnancy drug exposure cases necessary for close monitoring, types and characteristics of data on pregnancy drug exposure, the requirements of registry data, and essential items needed to be researched. Conclusions: Information on pregnancy drug exposure in Korea can be effectively collected by using this report which provides a comprehensive assess to drug's influence on pregnant women and fetus, and in addition, accurate information about safety and effectiveness of drug use in pregnant women and fetus can be obtained by sharing data globally and managing it synthetically and systematically.

Pharmaceutical Data Exclusivity - Comparative Study and Future Direction in Korea (의약품 자료독점제도의 국가별 현황과 국내 제도의 발전방향)

  • Park, Syl-Vi-A
    • Journal of Pharmaceutical Investigation
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    • v.39 no.4
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    • pp.299-307
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    • 2009
  • Data exclusivity is one of the most important intellectual property rights of pharmaceuticals. During data exclusivity period, third parties are prohibited from relying on the data which the original company has submitted to regulatory authority for drug application. I investigated data exclusivity systems for pharmaceuticals in the US, EU, Canada and Korea. New chemical entities were usually given the longest periods of data exclusivity compared to drugs with new indication or new formulation, although the protection periods varied by country. For new drugs to be entitled to a data exclusivity, strict conditions should be met. Data exclusivity has also been provided as an incentive to promote clinical investigation and drug development for pediatric population or orphan diseases. In Korea, data exclusivity was adopted in 1995 as an additive provision to "drug re-examination" which is to investigate post-marketing safety information of new drugs. It was introduced with few discussion on the purposes or effects of data exclusivity on pharmaceutical industry and pharmaceutical market in this country. I found that Korea's data exclusivity system falls short of considerations on valuing innovation of pharmaceutical research. It is necessary to improve data exclusivity system in order to promote innovative pharmaceutical development and to balance intellectual property rights protection and access to drugs in this country.