• Title/Summary/Keyword: Drug safety assessment

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Korean research project on the integrated exposure assessment of hazardous substances for food safety

  • Lim, Ji-Ae;Kwon, Ho-Jang;Ha, Mina;Kim, Ho;Oh, Se Young;Kim, Jeong Seon;Lee, Sang-Ah;Park, Jung-Duck;Hong, Young-Seoub;Sohn, Seok-Joon;Pyo, Heesoo;Park, Kyung Su;Lee, Kwang-Geun;Kim, Yong Dae;Jun, Sangil;Hwang, Myung Sil
    • Environmental Analysis Health and Toxicology
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    • v.30
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    • pp.4.1-4.11
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    • 2015
  • Objectives: This survey was designed to conduct the first nationwide dietary exposure assessment on hazardous substances including the intakes of functional food and herbal medicine. In this paper, we introduced the survey design and the results of the dietary exposure status and internal exposure levels of lead (Pb), cadmium (Cd), and mercury (Hg). Methods: We selected 4867 subjects of all ages throughout Korea. We conducted a food survey, dietary survey, biomonitoring, and health survey. Results: Pb and Cd were the highest (median value) in the seaweed ($94.2{\mu}g/kg$ for Pb; $594{\mu}g/kg$ for Cd), and Hg was the highest in the fish ($46.4{\mu}g/kg$). The dietary exposure level (median value) of Pb was $0.14{\mu}g/kg$ body weight (bw)/d, $0.18{\mu}g/kg$ bw/d for Cd, and $0.07{\mu}g/kg$ bw/d for Hg. Those with a blood Pb level of less than $5.00{\mu}g/dL$ (US Centers for Disease Control and Prevention, reference value for those 1 to 5 years of age) were 99.0% of all the subjects. Those with a blood Cd level with less than $0.30{\mu}g/L$ (German Federal Environmental Agency, reference value for non-smoking children) were 24.5%. For those with a blood Hg level with less than $5.00{\mu}g/L$ (human biomonitoring I, references value for children and adults, German Federal Environmental Agency) was 81.0 % of all the subjects. Conclusions: The main dietary exposure of heavy metals occurs through food consumed in a large quantity and high frequency. The blood Hg level and dietary exposure level of Hg were both higher than those in the European Union.

Clinical Evaluation of Granules Containing Antacids, Digestive Eneymes and Herb Drugs in Patients with Various Symptoms of Upper Gastrointestinal Disorders (상부 소화관 질환증상에 대한 제산, 소화효소 및 생약 세립의 유용성)

  • 구자영;박능화;최종수;안수열
    • YAKHAK HOEJI
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    • v.37 no.5
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    • pp.520-526
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    • 1993
  • The purpose of this study is to assess the clinical efficacy and safety of NRM granules which were newly developed as a combination product containing antacids, digestive enzymes and herb drugs for the treatmet of various symptoms of upper gastrointestinal disorders taking SGN granules of similiar but different composition as a control. One hundred and twenty one patients were randomly allocated to receive one pack of either NRM granule(80 cases) or SGN granules(41 cases) three times a day after meal and undergone symptomatic, endoscopic and clinical laboratory assessment before and after two weeks of treatment. The results were as follows; 1. All symptoms except anorexia showed improvements in more than 90% of total cases with each symptom in the NRM group. 2. The general improvement rate was 97.5% in NRM group, and was superior to the(92.5%) of SGN group. 3. Two cases of NRM group and one case of SGN group developed mild nausea, and onecase of SGN group developed mild epigastric soreness. No cases of the two groups developed laboratory(blood, biochemical, urine) abnormalities. 4. The overall clinical efficacy rate was 95.0% in NRM group, 87.8% in SGN group. kccording to the result of this trial, it was concluded that NRM granule was an effective and safe drug and(but not statistically significant) was slightly more efficient than SGN for treatment of various symptoms in upper gastrointestinal disorders.

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Smoking Cessation Strategies Targeting Specific Populations

  • Chun, Eun Mi
    • Tuberculosis and Respiratory Diseases
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    • v.82 no.1
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    • pp.1-5
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    • 2019
  • Quitting smoking helps smokers maintain their health and extend their lifespan by 10 or more years. Treatment strategies for smoking cessation should be tailored to individual smokers with special needs based on their specific circumstances. It is recommended that pregnant women adopt smoking cessation through counseling and behavioral interventions because the safety of medications has yet to be established. Counseling is the main strategy for smoking cessation in adolescents and nicotine replacement therapy can be used with caution in individuals with serious nicotine dependence. It is important for smokers with psychiatric diseases to quit smoking following accurate assessment of their depression status. Nicotine replacement therapy, varenicline, and bupropion can be used for smoking cessation in smokers with psychiatric disorders. The incidence of cardiovascular disease decreased according to the smoking status and the duration of smoking cessation. In smokers with chronic obstructive pulmonary disease (COPD) who used a combination of counseling and pharmacotherapy the quitting rate was more than twice as high as subjects who used behavioral interventions alone. Varenicline can be used as the most effective anti-smoking drug by most smokers including those with psychiatric disorders, cardiovascular disease, and COPD.

Monitoring of Pesticide Residues and Risk Assessment for Medicinal Plants (국내 유통 약용식물 중 잔류농약 모니터링 및 위해성 평가)

  • Ahn, Ji-Woon;Jeon, Young-Hwan;Hwang, Jeong-In;Kim, Jeong-Min;Seok, Da-Rong;Lee, Eun-Hyang;Lee, Sung-Eun;Chung, Duck-Hwa;Kim, Jang-Eok
    • Journal of Food Hygiene and Safety
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    • v.28 no.1
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    • pp.13-18
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    • 2013
  • This study was conducted to monitor residual pesticides in ginseng and balloon flower roots and to assess their risk to human health. All of 112 samples consisted of ginseng and balloon roots were purchased from traditional domestic markets and supermarkets in nine provinces of Korea in 2012. Multi-residue analysis of 122 pesticides was conducted and the analysis was performed by gas chromatography-electron capture detector, gas chromatography- nitrogen/phosphorus detector, and high-performance liquid chromatography. Seven pesticides were detected in 12 root samples and the detection rate was 10.7%. The detected twelve root samples were 10 ginseng root samples and 2 balloon root samples. Pesticides detected in root samples were procymidone, kresoxim-methyl, endosulfan, cypermethrin, tralomethrin, tetraconazole and chlorfluazuron. Among them, two pesticides as tetraconazole in a balloon flower root and cypermethrin in a ginseng root exceeded the recommended maximum residue limit set by Korea Food and Drug Administration. Five pesticides detected from 10 root samples were identified as unregistered pesticides in Korea. In order to do risk assessment with Korean medicinal plant consumption, estimated daily intake of residual pesticides were determined and compared to acceptable daily intake, referring to %ADI values. The range of %ADI values was from 0.006% to 0.333%. Taken together, it demonstrates the pesticides found in the two root samples were below the safety margin, indicating no effect on human health.

Creating a school nutrition environment index and pilot testing it in elementary and middle schools in urban South Korea

  • Park, Sohyun;Kwon, Kwang-il;Kweon, Soon Ju;Wang, Youfa;Gittelsohn, Joel
    • Nutrition Research and Practice
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    • v.11 no.5
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    • pp.402-411
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    • 2017
  • BACKGROUND/OBJECTIVES: The role of a school's nutrition environment in explaining students' eating behaviors and weight status has not been examined in an Asian setting. The purpose of this study was to create a school nutrition environment index and to pilot test the index in elementary and middle schools in urban South Korea. SUBJECTS/METHODS: This study used a mixed-methods approach. Environment assessment tools were developed based on formative research, which comprised literature reviews, in-depth interviews, and focus group discussions. Key elements from the formative research were included in the assessment tool, which consisted of a structured survey questionnaire for school dietitians. Fifteen school dietitians from 7 elementary and 8 middle schools in Seoul completed the questionnaire. RESULTS: The formative research revealed four main sections that guided a summary index to assess a school's nutrition environment: resource availability, education and programs, dietitians' perceptions and characteristics, and school lunch menu. Based on the literature reviews and interviews, an index scoring system was developed. The total possible score from the combined four index sections was 40 points. From the 15 schools participating in the pilot survey, the mean school nutrition-environment index was 22.5 (standard deviation ${\pm}3.2$; range 17-28). The majority of the schools did not offer classroom-based nutrition education or nutrition counseling for students and parents. The popular modes of nutrition education were school websites, posters, and newsletters. CONCLUSIONS: This paper illustrates the process used to develop an instrument to assess a school's nutrition environment. Moreover, it presents the steps used to develop a scoring system for creation of a school nutrition environment index. As pilot testing indicated the total index score has some variation across schools, we suggest applying this instrument in future studies involving a larger number of schools. Future studies with larger samples will allow investigation of the validity and reliability of this newly developed tool.

The Survey of Cold Storage Temperature and Determine of Appropriate Statistics Probability Distribution Model (국내 식품냉장창고 온도분포 분석 및 적정 확률분포모델 설정)

  • Kim, Hyong-Tae;Kim, Sang-Kyu;Behk, Ok-Jin;Bahk, Gyung-Jin
    • Journal of Food Hygiene and Safety
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    • v.27 no.3
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    • pp.312-316
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    • 2012
  • This study was to present the proper probability distribution models that based on the data for surveys of food cold storage temperatures as the input variables to the further MRA (Microbial risk assessment). The temperature was measured by directly visiting 7 food plants. The overall mean temperature for food cold storages in the survey was $2.55{\pm}3.55^{\circ}C$, with 2.5% of above $10^{\circ}C$, $-3.2^{\circ}C$ and $14.9^{\circ}C$ as a minimum and maximum. Temperature distributions by space-locations was $0.80{\pm}1.69^{\circ}C$, $0.59{\pm}1.68^{\circ}C$, and $0.65{\pm}1.46^{\circ}C$ as an upper (2.4~4 m), middle (1.5~2.4 m), and lower (0.7~1.5 m), respectively. Probability distributions were also created using @RISK program based on the measured temperature data. Statistical ranking was determined by the goodness of fit (GOF) to determine the proper probability distribution model. This result showed that the LogLogistic (-4.189, 5.9098, 3.2565) distribution models was found to be the most appropriate for relative MRA conduction.

Microstructure and Biocompatibility of Porous BCP(HA/β-TCP) Biomaterials Consolidated by SPS Using Space Holder

  • Woo, Kee-Do;Kwak, Seung-Mi;Lee, Tack;Oh, Seong-Tak;Woo, Jeong-Nam
    • Korean Journal of Materials Research
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    • v.26 no.8
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    • pp.449-453
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    • 2016
  • $HA(hydroxyapatite)/{\beta}-TCP$ (tricalcium phosphate) biomaterial (BCP; biphasic calcium phosphate) is widely used as bone cement or scaffolds material due to its superior biocompatibility. Furthermore, $NH_4HCO_3$ as a space holder (SH) has been used to evaluate feasibility assessment of porous structured BCP as bone scaffolds. In this study, using a spark plasma sintering (SPS) process at 393K and 1373K under 20MPa load, porous $HA/{\beta}-TCP$ biomaterials were successfully fabricated using $HA/{\beta}-TCP$ powders with 10~30 wt% SH, TiH2 as a foaming agent, and MgO powder as a binder. The effect of SH content on the pore size and distribution of the BCP biomaterial was observed by scanning electron microscopy (SEM) and a microfocus X-ray computer tomography system (SMX-225CT). The microstructure observations revealed that the volume fraction of the pores increased with increasing SH content and that rough pores were successfully fabricated by adding SH. Accordingly, the cell viabilities of BCP biomaterials were improved with increasing SH content. And, good biological properties were shown after assessment using Hanks balanced salt solution (HBSS).

In Vitro Genotoxicity Assessment of a Novel Resveratrol Analogue, HS-1793

  • Jeong, Min Ho;Yang, Kwangmo;Lee, Chang Geun;Jeong, Dong Hyeok;Park, You Soo;Choi, Yoo Jin;Kim, Joong Sun;Oh, Su Jung;Jeong, Soo Kyung;Jo, Wol Soon
    • Toxicological Research
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    • v.30 no.3
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    • pp.211-220
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    • 2014
  • Resveratrol has received considerable attention as a polyphenol with various biological effects such as anti-inflammatory, anti-oxidant, anti-mutagenic, anti-carcinogenic, and cardioprotective properties. As part of the overall safety assessment of HS-1793, a novel resveratrol analogue free from the restriction of metabolic instability and the high dose requirement of resveratrol, we assessed genotoxicity in three in vitro assays: a bacterial mutation assay, a comet assay, and a chromosomal aberration assay. In the bacterial reverse mutation assay, HS-1793 did not increase revertant colony numbers in S. typhimurium strains (TA98, TA100, TA1535 and TA1537) or an E. coli strain (WP2 uvrA) regardless of metabolic activation. HS-1793 showed no evidence of genotoxic activity such as DNA damage on L5178Y $Tk^{+/-}$ mouse lymphoma cells with or without the S9 mix in the in vitro comet assay. No statistically significant differences in the incidence of chromosomal aberrations following HS-1793 treatment was observed on Chinese hamster lung cells exposed with or without the S9 mix. These results provide additional evidence that HS-1793 is non-genotoxic at the dose tested in three standard tests and further supports the generally recognized as safe determination of HS-1793 during early drug development.

Residues and Exposure Assessment of Carbendazim in Chamnamul on Field Trials for Revising Maximum Residue Limit in Korea (생산단계 참나물의 Carbendazim 잔류특성에 따른 노출평가 및 농약 잔류허용기준 개선)

  • Chang, Hee-Ra;Gwak, Hye-Min
    • Korean Journal of Environmental Agriculture
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    • v.41 no.3
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    • pp.153-157
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    • 2022
  • BACKGROUND: The residue dissipation pattern of pesticides for agricultural products during the pre-harvest period after the final application is important to prevent the maximum residue limit (MRL) violations in domestic and export markets. The MRL violations of carbendazim are observed more often in chamnamul by pesticide residue management surveys by the Ministry of Food and Drug Safety. The residue level at the pre-harvest interval (PHI) and the residue dissipation constant from the critical good agricultural practice (cGAP) trials could be estimated to meet the MRL and pose a health risk to consumers. METHODS AND RESULTS: Chamnamuls were harvested at 0, 1, 3, 5, 7, 10, and 14 days after application of carbendazim in accordance with critical GAP. The residue analysis in chamnanul was performed by HPLC-DAD with the C18 column. The limit of quantitation of carbendazim was 0.04 mg/kg, and the recoveries were 74.4 - 95.8% at the two spiked levels (LOQ and 10LOQ) of carbendazim. The dissipation rates in chamnamul were calculated from the residues at the sampling days by statistical method at a 95% confidence level. The biological half-lives of residual carbendazim in the field trials 1 and 2 were 4.9 and 4.4 days, respectively. CONCLUSION(S): In this dissipation study, the residue concentrations at the recommended PHI were higher than the established MRL in Korea. Therefore, the MRL is proposed based on the residue data sets from the trials conducted at the same cGAP and the dietary exposure assessment.

Validation Study of a Dietary Questionnaire for Assessing Exposure to Food-Borne Hazards (식품으로 인한 유해물질 노출조사를 위한 식생활 설문지의 타당도 평가)

  • Kim, Hye-Mi;Choi, Seul-Ki;Shin, Sang-Ah;Lee, Kyung-Youn;Shin, Sang-Hee;Lee, Jung-Won;Yu, Soo-Hyun;Nam, Hye-Soen;Kim, Mi-Gyeong;Joung, Hyo-Jee
    • Journal of Nutrition and Health
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    • v.44 no.2
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    • pp.171-180
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    • 2011
  • Assessing human exposure to food-borne hazards requires standardized assessment tools. The objective of this study was to validate a newly developed dietary assessment questionnaire to assess human exposure to food-borne hazards, which include dietary behavior and food consumption patterns such as eating frequency, types of food containers and cooking methods. A total of 216 adults were recruited for two questionnaire surveys (questionnaire 1 and 2) about 1 week apart with a 3 day diet record. Reproducibility was evaluated by comparing responses from questionnaires 1 and 2, and validity was checked by comparing responses from questionnaire 2 and the 3 day diet record. Comparisons were based on the percent agreement and Spearman's rank correlation coefficient. The mean exact agreement of food containers at purchase between questionnaires 1 and 2 was 73.5%, for storing containers it was 71.9%, and for cooking methods it was 83.0%. The mean correlation coefficient for food intake frequency between questionnaires 1 and 2 was 0.71 (range, 0.50-0.83). The mean correlation coefficient of the food intake frequency between questionnaire 2 and the 3 day diet record was 0.21 (range, 0.04-0.48). The exact and adjacent agreement of food intake frequency quartile assessed by questionnaire 2 and the 3 day diet record was 65.4% (range, 51.0-82.1%). Although the correlation coefficient for food intake frequency between questionnaire 2 and the 3 day diet record was low, the exact and adjacent food intake frequency agreement was higher than 50% and reproducibility of the dietary behaviors exceeded 70%. Therefore, the questionnaire developed in this study could be applied to assess diets for the human exposure to food-borne hazards as a qualitative assessment in a large population.