• 대한약학회:학술대회논문집
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• 대한약학회 2000년도 춘계총회 및 학술대회
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• pp.198.3-199
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• 2000

• 대한약학회:학술대회논문집
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• 대한약학회 2000년도 춘계총회 및 학술대회
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• pp.202.3-203
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• 2000

• 한국식품위생안전성학회:학술대회논문집
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• 한국식품위생안전성학회 2004년도 제3회 식품안전의 날 기념 학술 세미나
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• pp.245-245
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• 2004

• 한국환경성돌연변이발암원학회:학술대회논문집
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• 한국환경성돌연변이발암원학회 2004년도 춘계학술대회
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• pp.123-123
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• 2004

• 대한약학회:학술대회논문집
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• 대한약학회 2001년도 Proceedings of the Pharmaceutical Society of Korea
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• pp.157.1-157.1
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• 2001

• 대한약학회:학술대회논문집
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• 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.1
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• pp.298.2-298.2
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• 2003

The insulinotropic hormone, glucagons-like peptide-1 (GLP-1), which has been proposed as a new potential therapeutics for type-II diabetes, but this is metabolized extremely rapidly by the ubiquitous enzyme, dipeptidyl peptidase IV (DPP IV), forming a metabolite, which acts as an antagonist at the GLP-1 receptor. (omitted)

• 대한의용생체공학회:의공학회지
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• 제31권4호
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• pp.280-284
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• 2010

Approvals of medical device increase every year as industry of medical device grows. Therefore KFDA keeps trying to improve approval systems. However, the firms of medical device are in trouble due to regulation amendment, a firm of small size, exchange of the person in charge. The staffs of KFDA increase their work load because applicants of approval of medical device aren't used to writing of document. Therefore the firm of medical device in business have a long term. KFDA develops eight guidance document item by item for one-step evaluation and approval for Medical Devices because applicants of approval of medical device write documents easily. KFDA reviewer can carry on quick reviewing in use of this eight guidances. This guidance are improved on satisfaction of applicants of approval of medical device.

• Toxicological Research
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• 제33권1호
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• pp.43-48
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• 2017

With ultraviolet and visible light exposure, some pharmaceutical substances applied systemically or topically may cause phototoxic skin irritation. The major factor in phototoxicity is the generation of reactive oxygen species (ROS) such as singlet oxygen and superoxide anion that cause oxidative damage to DNA, lipids and proteins. Thus, measuring the generation of ROS can predict the phototoxic potential of a given substance indirectly. For this reason, a standard ROS assay (ROS assay) was developed and validated and provides an alternative method for phototoxicity evaluation. However, negative substances are over-predicted by the assay. Except for ultraviolet A (UVA), other UV ranges are not a major factor in causing phototoxicity and may lead to incorrect labeling of some non-phototoxic substances as being phototoxic in the ROS assay when using a solar simulator. A UVA stimulator is also widely used to evaluate phototoxicity in various test substances. Consequently, we identified the applicability of a UVA simulator to the ROS assay for photoreactivity. In this study, we tested 60 pharmaceutical substances including 50 phototoxins and 10 non-phototoxins to predict their phototoxic potential via the ROS assay with a UVA simulator. Following the ROS protocol, all test substances were dissolved in dimethyl sulfoxide or sodium phosphate buffer. The final concentration of the test solutions in the reaction mixture was 20 to $200{\mu}M$. The exposure was with $2.0{\sim}2.2mW/cm^2$ irradiance and optimization for a relevant dose of UVA was performed. The generation of ROS was compared before and after UVA exposure and was measured by a microplate spectrophotometer. Sensitivity and specificity values were 85.7% and 100.0% respectively, and the accuracy was 88.1%. From this analysis, the ROS assay with a UVA simulator is suitable for testing the photoreactivity and estimating the phototoxic potential of various test pharmaceutical substances.

• Toxicological Research
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• 제28권2호
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• pp.73-79
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• 2012

While the ability to develop nanomaterials and incorporate them into products is advancing rapidly worldwide, understanding of the potential health safety effects of nanomaterials has proceeded at a much slower pace. Since 2008, Korea Food and Drug Administration (KFDA) started an investigation to prepare "Strategic Action Plan" to evaluate safety and nano risk management associated with foods, drugs, medical devices and cosmetics using nano-scale materials. Although there are some studies related to potential risk of nanomaterials, physical-chemical characterization of nanomaterials is not clear yet and these do not offer enough information due to their limitations. Their uncertainties make it impossible to determine whether nanomaterials are actually hazardous to human. According to the above mention, we have some problems to conduct the human exposure risk assessment currently. On the other hand, uncertainty about safety may lead to polarized public debate and to businesses unwillingness for further nanotechnology investigation. Therefore, the criteria and methods to assess possible adverse effects of nanomaterials have been vigorously taken into consideration by many international organizations: the World Health Organization, the Organization for Economic and Commercial Development and the European Commission. The object of this study was to develop risk assessment principles for safety management of future nanoproducts and also to identify areas of research to strengthen risk assessment for nanomaterials. The research roadmaps which were proposed in this study will be helpful to fill up the current gaps in knowledge relevant nano risk assessment.

• 약학회지
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• 제55권4호
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• pp.284-288
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• 2011

The test method for biologics of lot release system is based on 'Test procedure and specification for biological products,' generally, thimerosal content is measured by chemical analysis using O.D. In this study, the comparative analysis was carried out using the gold amalgamation method for thimerosal content was compared to the existing methods, which are described above. The gold amalgamation method, which uses atomic absorption spectrophotometry, was meets all the method validation acceptance criteria. It is considered to be proper as the assay and identification test for thimerosal. In this study, the comparative analysis was performed three times. As a result, gold amalgamation method is more convenient and easy to perform as this assay doesn't have pre-treatment procedure. Also this assay showed good precision and reproducibility compared to the conventional method. Therefore, it is appropriate to alternate the assay method of thimerosal from the conventional chemical analysis to gold amalgamation method to improve the credibility of lot release system and the quality control of biologics, by standardizing test method.