• Title/Summary/Keyword: Drug evaluation

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Standardization of uniformity of dosage unit for oral dosage forms

  • Kang, Shin-Jung;Yun, Mi-Ok;Choi, Hyun-Cheol;Kim, Ho-Jeong;Kim, Ji-Sun;Kim, Gil-Su
    • Proceedings of the PSK Conference
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    • 2002.10a
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    • pp.414.2-414.2
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    • 2002
  • To secure the safety of drugs without compromising drug efficacy, it can not be more important to administer the exact intended amount of active ingredients to patients. Even if the correct amount of drugs are taken in the correct manner, drug can be overdosed or less-dosed without intention unless the content uniformity of the unit dose were secured. Especially, it can be a serious problem when it comes to drugs with narrow therapeutic windows or a strong pharmacological activity at a small dose. (omitted)

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A study on the evaluation of artificial cartilage using synthetic biodegradable polymers

  • Oh, Ho-Jung;Lee, Nam-Kyung;Kim, Soon-Nam;Hong, Choong-Man;Lee, Ki-Hong;Yoo, Si-Hyung;Shin, In-Soo;Lim, Jae-Hyun;Choi, Seung-Eun
    • Proceedings of the PSK Conference
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    • 2003.10b
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    • pp.100.1-100.1
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    • 2003
  • Tissue engineering has arisen to address the extreme shortage of tissues and organs for transplantation and repair. One of the most successful techniques has been the seeding and culturing cells on three-dimensional biodegradable scaffolds in vitro followed by implantaion in vivo. We used PLA and PLGA as biodegradable polymers and rabbit chondrocytes were isolated and applied to PLA and PLGA to make artificial cartilage. To evaluate the biocompatibility and biological safety of polymers, in vitro cytotoxicity and in vivo animal tests were investigated. (omitted)

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Comparative Study of the Korean Pharmacopoeia with North Korean Pharmacopoeia (남.북한 약전에 대한 비교조사연구)

  • Choi, Myoeng-Sin;Kang, Chan-Soon;Kim, Hye-Soo;Kim, Eun-Jung;Hong, Chong-Hui;Ko, Yong-Seok;Kim, Sang-Hyun;Jang, Sung-Jae
    • Journal of Pharmaceutical Investigation
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    • v.34 no.5
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    • pp.427-433
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    • 2004
  • With the Sunshine policy, exchange of materials and cultures inter Koreas has been broadened and expectancy of reunification is getting higher. Especially, medical supplies and medicines are one of the biggest parts in the exchange goods. So, preparing an unified official drug standard preparing new medical administration system is required. We compared the Korean pharmacopoeia with North Korean Pharmacopoeia. Two pharmacopoeias have been developed in different direction and have many differences in the nomenclature and format. In this study, we compared general notices, general rules for preparations and crude drugs, monographs, general tests, processes and apparatus.

Enhancement of Analytical Method for Thidiazuron Residues and Monitoring of its Residues in Agricultural Commodities (농산물 중 thidiazuron 잔류분석법 개선 및 잔류실태 조사)

  • Do, Jung-Ah;Lee, Mi-Young;Park, Hyejin;Kwon, Ji-Eun;Cho, Yoon-Jae;Chang, Moon-Ik;Oh, Jae-Ho;Hong, Jin-Hwan
    • Korean Journal of Environmental Agriculture
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    • v.32 no.3
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    • pp.207-213
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    • 2013
  • BACKGROUND: This study was conducted to develop analytical method with reproducibility, accuracy and applicability to agricultural products than the existing methods. METHODS AND RESULTS: Mean recoveries of thidiazuron ranged from 89.2 to 91.2 in hulled rices, 87.2 to 92.1 in peppers, from 76.4 to 86.9 in potatoes, from 91.2 to 95.7 in watermelons, from 86.5 to 88.5 in kiwi fruits, and from 89.5 to 94.0 in grapes, with less than 10% of relative standard deviations. In addition, the limit of quantitation was set to be 0.05 mg/kg and there were no interfering peaks in integrating the thidiazuron peak. CONCLUSION(S): These results represent that the enhanced analytical method has reliable accuracy, precision, selectivity, and sensitivity.

A Collaborative Study to Establish a Korea National Biological Standard for Antithrombin III Concentrate

  • Kang, Hye-Na;Oh, Ho-Jung;Kim, Soon-Nam;Hong, Choong-Man;Lee, Ki-Hong;Yoo, Si-Hyung;Shin, In-Soo;Choi, Seung-Eun;Lee, Seok-Ho
    • Proceedings of the PSK Conference
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    • 2003.04a
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    • pp.149.2-149.2
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    • 2003
  • We have carried out a collaborative study to evaluate a candidate preparation of antithrombin III concentrate whether it is suitable to serve as a Korea National Biological Standard. Three National Control Laboratories and three manufacturers participated in this study. The potency of this candidate preparation was determined by using a heparin cofactor chromogenic method described in the Minimum Requirements for Biological Products and the European Phamacopoeia. (omitted)

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Application and Validation of an Optimal Analytical Method using QuEChERS for the determination of Tolpyralate in Agricultural Products (QuEChERS법을 활용한 농산물 중 제초제 Tolpyralate의 최적 분석법 선발 및 검증)

  • Lee, Han Sol;Park, Ji-Su;Lee, Su Jung;Shin, Hye-Sun;Kim, Ji-Young;Yun, Sang Soon;Jung, Yong-hyun;Oh, Jae-Ho
    • Korean Journal of Environmental Agriculture
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    • v.39 no.3
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    • pp.246-252
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    • 2020
  • BACKGROUND: Pesticides are broadly used to control weeds and pests, and the residues remaining in crops are managed in accordance with the MRLs (maximum residue limits). Therefore, an analytical method is required to quantify the residues, and we conducted a series of analyses to select and validate the quick and simple analytical method for tolpyralate in five agricultural products using QuEChERS (quick, easy, cheap, effective, rugged and safe) method and LC-MS/MS (liquid chromatography-tandem mass spectrometry). METHODS AND RESULTS: The agricultural samples were extracted with acetonitrile followed by addition of anhydrous magnesium sulfate, sodium chloride, disodium hydrogencitrate sesquihydrate and trisodium citrate dihydrate. After shaking and centrifugation, purification was performed with d-SPE (dispersive-solid phase extraction) sorbents. To validate the optimized method, its selectivity, linearity, LOD (limit of detection), LOQ (limit of quantitation), accuracy, repeatability, and reproducibility from the inter-laboratory analyses were considered. LOQ of the analytical method was 0.01 mg/kg at five agricultural products and the linearity of matrix-matched calibration were good at seven concentration levels, from 0.0025 to 0.25 mg/L (R2≥0.9980). Mean recoveries at three spiking levels (n=5) were in the range of 85.2~112.4% with associated relative standard deviation values less than 6.2%, and the coefficient of variation between the two laboratories was also below 13%. All optimized results were validated according to the criteria ranges requested in the Codex Alimentarius Commission (CAC) and Ministry of Food and Drug Safety (MFDS) guidelines. CONCLUSION: In conclusion, we suggest that the selected and validated method could serve as a basic data for detecting tolpyralate residue in imported and domestic agricultural products.