• Title/Summary/Keyword: drug use evaluation

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Evaluation of micro jet nozzle using finite elements method (유한요소해석을 이용한 마이크로 분사 노즐 특성 평가)

  • Lim, Dong-Wook;Choi, Doo-Sun;Kim, Tae-min;Park, Jung-Rae;Park, Kyu-Bag;Ham, Hwi-Chan;Kim, Ji-Hun
    • Design & Manufacturing
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    • v.14 no.3
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    • pp.57-62
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    • 2020
  • In the drug delivery system industry, the technology with even split injection becomes important for maximizing efficiency and minimizing the side effects. In conventional drug delivery system, infection can occur due to pain and splashing. Also, various applications are impossible due to disposable use, and it is the reason to avoid to use this system because of the complexity of the driving method. Therefore, in this study, a painless drug delivery device is developed for non-pain with electrical insulation breakdown method. Finite elements analysis was used to evaluate the ejection characteristics of drugs according to the shape of the micro ejection nozzle. The effect of the number of holes in the micro nozzle, the length of the nozzle and the inner shape of the nozzle on the drug discharge characteristics were analyzed.

Development of Method using LC-ESI-MS/MS and KASP for Identification of Gymnema sylvestre in Food (식품에서 당살초 판별을 위한 LC-ESI-MS/MS 분석법과 KASP 마커 개발)

  • Park, Boreum;Lee, Sun Hee;Eom, Kwonyong;Noh, Eunyoung;Moon Han, Kyoung;Hwang, Jinwoo;Kim, Hyungil;Baek, Sun Young
    • Journal of Food Hygiene and Safety
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    • v.37 no.2
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    • pp.46-54
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    • 2022
  • Known for its effectiveness in weight loss and diabetes prevention, Gymnema sylvestre products can be found in the US, Japanese, and Indian markets. However, the recommended dosage or safety of these products has not yet been proven. Therefore, development of an analytical method for detecting the content of Gymnema sylvestre in food products is required. Accordingly, this study proposes an analysis method that can examine Gymnema sylvestre in food using LC-ESI-MS/MS and KASP (Kompetitive Allele-Specific PCR) markers. In LC-ESI-MS/MS, a simultaneous analysis method for gymnemic acid and deacylgymnemic acid was optimized using negative ionization mode, and its validation test was completed for solid and liquid samples. In addition, KASP markers were prepared by finding the specific SNP of G. sylvestre in ITS2 and matK through DNA barcodes. The two KASP markers returned positive FAM fluorescence result when combined with G. sylvestre, and this aspect was confirmed in raw G. sylvestre as well. The applicability of the method was tested on 21 different food and healthy functional products containing G. sylvestre purchased on the internet. As a result, although there was a difference in the ratios of gymnemic acid and deacylgymnemic acid in LC-ESI-MS/MS, the index component was detected in all 21 products samples. In the KASP analysis, 9 products returned positive FAM result, and the rest of the products were found to be containing G. sylvestre extract. This study is the first study to use the dual system of LC-ESI-MS/MS and KASP for the analysis of G. sylvestre. The study has confirmed that these two methods are applicable to the examine G. sylvestre content in food products.

Monitoring of Red Pepper Powder and Seasoned Red-Pepper Sauce using Species-Specific PCR in Conjunction with Whole Genome Amplification

  • Hong, Yewon;Kwon, Kisung;Kang, Tae Sun
    • Journal of Food Hygiene and Safety
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    • v.33 no.2
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    • pp.146-150
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    • 2018
  • Red pepper is one of the most important spices popularly utilized in Korea. Because of the differences in tariff rates between red pepper powder and seasoned red-pepper sauce, seasoned red-pepper sauce is often therefore imported by consumers, then dried, ground, and added to red pepper powder for cost effective purposed to use the product the most effectively. In this study, we combined species-specific polymerase chain reaction (PCR) assays (for red pepper, garlic, onion, spring onion, and ginger) with whole-genome amplification (WGA). Thirty-nine red pepper powders were well in accordance with their labels. However, six red pepper powder and five seasoned red-pepper sauce products failed to meet their compliance requirements. As a consequence, our monitoring results revealed that the overall mislabeling rate detected in this study was identified at 22%. Thus, our findings showed that the species-specific PCR in conjunction with WGA was an ideal method to identify raw materials that are used in the manufacturing of red pepper powder and seasoned red-pepper sauce.

Studies on Xylooligosaccharide Analysis Method Standardization using HPLC-UVD in Health Functional Food (건강기능식품에서 HPLC-UVD를 이용한 자일로올리고당 시험법의 표준화 연구)

  • Se-Yun Lee;Hee-Sun Jeong;Kyu-Heon Kim;Mi-Young Lee;Jung-Ho Choi;Jeong-Sun Ahn;Kwang-Il Kwon;Hye-Young Lee
    • Journal of Food Hygiene and Safety
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    • v.39 no.2
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    • pp.72-82
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    • 2024
  • This study aimed to develop a scientifically and systematically standardized xylooligosaccharide analytical method that can be applied to products with various formulations. The analysis method was conducted using HPLC with Cadenza C18 column, involving pre-column derivatization with 1-phenyl-3-methyl-5-pyrazoline (PMP) and UV detection at 254 nm. The xylooligosaccharide content was analyzed by converting xylooligosaccharide into xylose through acid hydrolysis. The pre-treated methods were compared and evaluated by varying sonication time, acid hydrolysis time, and concentration. Optimal equipment conditions were achieved with a mobile phase consisting of 20 mM potassium phosphate buffer (pH 6)-acetonitrile (78:22, v/v) through isocratic elution at a flow rate of 0.5 mL/min (254 nm). Furthermore, we validated the advanced standardized analysis method to support the suitability of the proposed analytical procedure such as specificity, linearity, detection limits (LOD), quantitative limits (LOQ), accuracy, and precision. The standardized analysis method is now in use for monitoring relevant health-functional food products available in the market. Our results have demonstrated that the standardized analysis method is expected to enhance the reliability of quality control for healthy functional foods containing xylooligosaccharide.

Development of Evaluation Method for Drug Release Propreties in Drug Eluting Stent (약물방출스텐트의 약물 방출 특성 평가 방법 개발)

  • Song, J.M.;Baek, H.;Lee, S.Y.;Jang, D.H.;Seo, M.Y.;Park, G.J.;Maeng, Eun-Ho
    • Journal of Biomedical Engineering Research
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    • v.34 no.2
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    • pp.69-72
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    • 2013
  • The goal of this study is to develop test method for evaluating the drug eluting properties of drug eluting stents (DES). PBS and the detergent solutions, presented by each DES manufacturer, were used for drug release of DES coated with paclitaxel, zotarolimus and everolimus. The drugs which are coating DES were not released by PBS but released by the detergent solutions, finally paclitaxel 83.38%, zotarolimus 103.85% and everolimus 115.78%. It seems that the use of the detergents is necessary in order to release the drugs because those drugs are extremely hydrophobic. In conclusion, using of detergent solutions presented by each manufacturer were suitable for evaluating the drug eluting property of drug eluting stent.

Toxicity Assessment of Polygalae Radix Aqueous Extract Orally Administered to Rats for 2 Consecutive Weeks (원지 추출물의 랫드에서 2주 반복 경구투여 독성평가)

  • Han, Hyoung-Yun;Kim, Soo Nam;Yang, Young-Su;Han, Su-Cheol;Seok, Ji-Hyeon;Roh, Hang Sik;Lee, Jong-Kwon;Jeong, Jayoung;Jeong, Yeon Woo;Kim, Jeong Ah;Min, Byung Sun
    • Korean Journal of Pharmacognosy
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    • v.46 no.1
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    • pp.44-51
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    • 2015
  • The objective of this study is to characterize a toxicity of Polygalae Radix (PR) in F344 rats and to find a dose levels for the 13 weeks toxicity study. PR is well known as medicinal herb in many Asian countries for treatment of expectorant, tonic, tranquillizer, antipsychotic agent and functional diet for improving memory. However, there is insufficient background information on toxicological evaluation of PR extract to support its safe use. Therefore, we conducted toxicological evaluation of this drug in compliance with OECD and KFDA guideline in this study. The extract of PR was administered orally to F344 rats at dose levels of 0, 500, 1000, 2000, 3500 and 5000 mg/kg/day for 2 weeks. Each group was composed to five male and five female rats. In the result, there were no treatment PR-related adverse changes in food consumption, hematology, clinical chemistry, urinalysis, gross finding at necropsy, organ weight examination. Four males at 5000 mg/kg/day were found dead during the treatment period. These animals showed salivation. The cause of death is still under investigation. The animals treated at 500, 1000, 2000, 3500 and 5000 mg/kg/day showed salivation and all animals at 5000 mg/kg/day exhibited lower body weight and cumulative weight gain in compared to those of control animals. Therefore, we recommend that a dose group of 3500 mg/kg/day is a highest treatment group in 13-week exposure study.

Changes in the Behavior of Healthcare Organizations Following the Introduction of Drug Utilization Review Evaluation Indicators in the Healthcare Quality Evaluation Grant Initiative (의료질평가지원금 제도의 의약품안전사용서비스 평가지표 도입에 따른 의료기관의 행태 변화)

  • Hyeon-Jeong Kim;Ki-Bong Yoo;Young-Joo Won;Han-Sol Jang;Kwang-Soo Lee
    • Health Policy and Management
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    • v.34 no.2
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    • pp.178-184
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    • 2024
  • Background: This study aimed to determine the effectiveness of drug utilization review (DUR) evaluation indicators on safe drug use by comparing the changes in DUR inspection rates and drug duplication prescription prevention rates between the pre- and post-implementation of the DUR evaluation indicators of the Healthcare Quality Evaluation Grant Initiative. Methods: This study used DUR data from the Health Insurance Review and Assessment Service in 2018 (pre-implementation) and the evaluation results of the Healthcare Quality Evaluation Grant Initiative in 2023 (post-implementation). The dependent variables were the DUR evaluation indicators, including DUR inspection rate and drug duplicate prescription prevention rate. The independent variable was the implementation of the DUR evaluation indicators, and the control variables included medical institution characteristics such as type, establishment classification, location, DUR billing software company, and number of beds. Results: The results of the analysis of the difference in the prevention rate of drug duplicate prescriptions between the pre- and post-implementation of the DUR evaluation indicators of the Healthcare Quality Evaluation Grant Initiative showed that the prevention rate of drug duplicate prescriptions increased statistically significantly after the implementation of the DUR evaluation indicators. Conclusion: The policy implications of this study are as follows: First, ongoing evaluation of DUR systems is needed. Second, it is necessary to establish a collaborative partnership between healthcare organizations that utilize DUR system information and the organizations that manage it.

Risk-based approach to develop a national residue program: prioritizing the residue control of veterinary drugs in fishery products

  • Kang, Hui-Seung;Han, Songyi;Cho, Byung-Hoon;Lee, Hunjoo
    • Fisheries and Aquatic Sciences
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    • v.22 no.12
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    • pp.29.1-29.7
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    • 2019
  • Veterinary drugs are widely used to protect production-related diseases and promote the growth of farmed fish. The use of large amounts of veterinary drugs may have potential risk and cause adverse effects on both humans and the environment. In this study, we developed risk-based ranking based on a scoring system to be applied in the national residue program. In this approach, the following three factors of veterinary drugs that may occur as residues in fishery products were considered: potency (acceptable daily intake), usage (number of dose and withdrawal period), and residue occurrence. The overall ranking score was calculated using the following equation: potency × usage (sum of the number of sales and withdrawal period) × residue occurrence. The veterinary drugs that were assigned high score by applying this approach were enrofloxacin, amoxicillin, oxolinic acid, erythromycin, and trimethoprim. The risk-based approach for monitoring veterinary drugs can provide a reliable inspection priority in fishery products. The developed ranking system can be applied in web-based systems and residuemonitoring programs and to ensure safe management of fishery products in Korea.

Efficacy and Safety of Cinacalcet for Secondary Hyperparathyroidism in Dialysis Patients and Drug Use Evaluation (투석환자의 이차성 부갑상선 기능 항진증 치료에서 cinacalcet의 유효성과 안전성 및 사용 적정성 평가)

  • Seo, Hee Nam
    • Korean Journal of Clinical Pharmacy
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    • v.23 no.2
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    • pp.142-150
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    • 2013
  • Background: Secondary hyperparathyroidism (SHPT) is common in patients with chronic kidney disease, affecting most of those who are receiving dialysis. Cinacalcet, a novel calcimimetic, targets the calcium-sensing receptor to lower PTH levels in dialysis patients. Objective: This study aimed to assess efficacy, safety and appropriateness of use of cinacalcet in dialysis patients. Method: This retrospective study was performed on total 24 cases with identified intact parathyroid hormone (iPTH), serum calcium and phosphorus levels before and 4 weeks after cinacalcet initiation at a teaching hospital from July 1st, 2011 to October 31st, 2012. Results: Cinacalcet decreased iPTH by 19% from baseline after 4weeks treatment and it was statistically significant (p<0.001). Cinacalcet also significantly decreased iPTH levels regardless of dialysis modality (hemodialysis group versus peritoneal dialysis group) and severity of SHPT (iPTH 300-800 pg/ml group versus iPTH >800 pg/ml group). Serum calcium, phosphorus and Ca x P levels were decreased without statistical significance. Gastrointestinal events, headache and hypocalcemia were the most common side effects. Monitoring for iPTH and serum calcium was not performed appropriately. 43.7% patients initiated cinacalcet therapy at serum calcium level< 9.0 mg/dl. Conclusion: In conclusion, cinacalcet lowers parathyroid hormone levels with no serious side effects. However, it is required to avoid cinacalcet treatment in patients with low serum calcium levels and monitor iPTH and serum calcium levels during cinacalcet administration.

I. Primary cultured hepatocytes as a key in vitro model to improve preclinical drug development (간세포 배양-약물대사를 위한 모델 연구)

  • 이경태
    • Proceedings of the Korean Society of Applied Pharmacology
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    • 1994.11a
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    • pp.135-140
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    • 1994
  • Over past decades, numerous in vitro model has been developed to investigate drug metabolism. In the order of complexity we found the isolated perfused liver, hepatocytes in co-culture with epithelial cells, hepatocytes in suspension and in primary culture and subcellular hepatic microsomal fractions. Because they can be easily prepared from both animals (pharmacological and toxicological species) and humans (whole livers as well as biopsies obtained during surgery) hepatocytes in primary culture provide the most powerful model to better elucidate drug behavior at an early stage of preclinical development such as : 1. the characterization of main biotransformation reactions. 2. the identification of phase I and phase II isozymes involved in such reactions 3. the evaluation of interspecies differences allowing the selection of a second toxicological animal species more closely related to man on the basis of metabolic profiles 4. the detection of the inducing and/or inhibitory effects of a drug on metabolic enzymes, the prediction of drug interactions 5. the estimation of inter-individual variability in biotransformation reactions. The use of hepatocytes, and in particular those obstained from humans, at an early stage of drug development allows the obtention of more predictive preclinical data and a better knowledge of drug behavior in humans before the first administration of the drug in healthy volunteers.

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