• 제목/요약/키워드: Korea Food Drug Administration

검색결과 1,739건 처리시간 0.03초

Effect of capsaicin on melanoma growth and metastasis

  • Kim, Ok-Hee;Jun, Hye-Seung;Han, Beom-Seok;Song, Chi-Won;Lee, Chang ki;Park, Mi-Sun;Eom, Mi-Ok;Jee, Seung-Wan;Ryeom, Tai-Kyung
    • 한국독성학회:학술대회논문집
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    • 한국독성학회 2002년도 Molecular and Cellular Response to Toxic Substances
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    • pp.143-143
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    • 2002
  • Capsaicin (8-methyl-N-vanillyl-6-nonenamide), a pungent ingredient of hot chili peppers, has been reported to possess substantial anticarcinogenic and antimutagenic activities. In our previous study, we found that capsaicin (100 ${\mu}$M) induced significant inhibition of matrix metalloproteinase-2 activity by gelatin zymography, and that capsaicin (i.p., 2.5mg/kg) inhibited development of lung colonization (58%) in experimental lung metastasis assay.(omitted)

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THE EFFECT OF BISPHENOL A ON THE THYROID HORMONE SYSTEM FOR THE ESTABLISHMENT OF SCREENING METHOD OF ENDOCRINE DISRUPTORS

  • Cho, Mi-Young;Lim, Myung-Sin;Lee, Young-Choi;Jung, Ki-Kyung;Nam, Kyung-Tak;Kim, Tae-Gyun;Kang, Ju-Hye;Kang, Seog-Youn;Kim, Seung-Hee
    • 한국독성학회:학술대회논문집
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    • 한국독성학회 2002년도 Molecular and Cellular Response to Toxic Substances
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    • pp.162-162
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    • 2002
  • There has been many findings of natural, environmental or manufactered nonsteroidal substances shown to have estrogenic activity. Since estrogens affect reproduction and cellular development to cause disease in people or animals, chronic exposure may have a major impact on health.(omitted)

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

  • 최명신;강찬순;김혜수;김은정;홍정희;고용석;김상현;장성재
    • Journal of Pharmaceutical Investigation
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    • 제34권5호
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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.

의료기기 허가.기술문서 원자재 작성 가이드라인 개발 (The Development for guideline of raw matrials on technical document of Medical Device)

  • 박기정;유규하;이성희;이창형;정진백;이재근;허찬회;김형범;최민용;김용우;황상연;정재훈;구자중;홍혜경;임경택;강세구;곽지영
    • 대한의용생체공학회:의공학회지
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    • 제31권6호
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    • pp.434-437
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    • 2010
  • For approval of medical devices manufactured or imported, submission of technical documents as well as the application form is required. The manufacturer (or importer) should properly identify the raw materials the applied product is made of and the manufacturing processes the product undergoes before it is shipped in the application form. In the technical documents, scientific data to evaluate the efficacy, safety, and quality of the applied product that has been described in the application form should be provided. Therefore, identifying the raw materials that were used for the parts of the applied product and describing the physical and chemical characteristics of the raw materials are quite important and essential in ensuring the efficacy, safety, and quality of the applied product. To describe the physical and chemical characteristics of the raw materials correctively, the applicant is required to have broad knowledge in the scientific fields such as chemical, polymer, metal, and ceramic science and engineering. But most of the applicant are not experts in these fields, so that the description in the application form often includes wrong and improper descriptions. Thus, we developed a guideline which explains the raw materials for medical devices, show the their examples. The purpose of this description guideline is to help the applicant properly completing the "Raw materials or constituents and their volumes" part in the application form.

Levels of 14-Polycyclic Aromatic Hydrocarbons in Meat Products

  • Lee, Hyomin;Eunkyung Yoon;Lee, Gunyoung;Kim, Hyeonjeong;Park, Kyungah;Kim, Yunhee;Jisun Yang
    • 한국독성학회:학술대회논문집
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    • 한국독성학회 2003년도 추계학술대회
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    • pp.196-196
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    • 2003
  • Food is a significant source of polycyclic aromatic hydrocarbons (PAHs) to which humans are exposed. In this study, we are analysed 14 PAHs in baked and smoked meats known as major source of PAHs, and defined a correlation between benzo(a)pyrene and pyrene to compare estimating risk from human exposure to PAHs with urinary1-hydroxypyrene.(omitted)

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Evaluation of neutral red uptake assay using Balb/c 3T3 cells as a screening test to predict skin phototoxicity potential

  • Lee, Jong-Kwon;Lee, Eun-Hee;Kim, Ju-Hwan;Hong, Jin-Tae;Kim, Hyung-Soo;Park, Ki-Sook;Ahn, Kwang-Soo;Cho, Dae-Hyun;Lee, Sun-Hee
    • 한국독성학회:학술대회논문집
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    • 한국독성학회 2001년도 International Symposium on Signal transduction in Toxicology
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    • pp.109-109
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    • 2001
  • In order to evaluate the neutral red uptake assay as an alternative method for phototoxicity test, we compared the potential of phototoxicity in vitro in cultured human fibroblasts and 3T3 fibroblast cells derived from Balb/c mice. Both fibroblasts were exposed to various known phototoxic chemicals (promethazine, neutral red, chlorpromazine, chlortetracycline, amiodarone, bithionol, 8-methoxypsoralen) and non-phototoxic chemical (ammonium laureth sulfate) and irradiated with 5 J/cm$^2$ of UVA.(omitted)

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Listeria monocytogenes와 Salmonella spp.에 대한 Sodium Hypochlorite 및 Benzalkonium Chloride의 유효성 평가 (Evaluation on Efficacies of Sodium Hypochlorite and Benzalkonium Chloride against Listeria monocytogenes and Salmonella spp.)

  • 김형일;윤혜정;최현철;전대훈;엄미옥;성준현;박나영;원선아;김남희;성덕화;곽효선;권기성;이영자
    • 한국식품위생안전성학회지
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    • 제22권2호
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    • pp.132-136
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    • 2007
  • 살균소독력 평가균주로 사용되는 E. coli ATCC 10536과 Staphylococcus aureus ATCC 6538균에 대하여 5 logCFU/ml 감소의 살균소독력을 보이는 살균소독제가 국내에서 식중독을 일으키고 있는 식중독 원인균 중 Salmonella spp.와 Listeria monocytogenes에 대하여도 같은 살균소독력을 나타내는지 비교평가하였다. 청정조건 및 오염조건에서 현탁액시험법을 사용하여 차아염소산나트륨과 염화벤잘코늄의 살균소독력을 평가하였다. 시험균주로는 E. coli ATCC 10536, Staphylococcus aureus ATCC 6538, Salmonella typhimurium ATCC 13311, Salmonella Enteritidis ATCC 13076, Listeria monocytogenes ATCC 19111, Salmonella spp. 10균주 및 Listeria monocytogenes 11균주를 사용하였다. 오염조건에서는 염화벤잘코늄만이 살균소독제의 유효성분 사용범위 농도 내에서 5 log 감소 이상의 살균소독력을 보였으나, 청정조건에서는 실험대상 균주 전부 5 log감소 이상의 살균소독력을 보였다.

벌꿀 중 동물용의약품 잔류량 모니터링 (Monitoring of Veterinary Medicine Residues in Honey)

  • 강은귀;정용현;정지혜;김미란;이경진;정진주;박종석;반경녀;장영미;강찬순
    • 한국식품과학회지
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    • 제42권6호
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    • pp.643-647
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    • 2010
  • 기준 설정 전인 2006년 식품의약품안전청에서 실시한 연구과제의 결과보고서에 의하면 200건 벌꿀 중 네오마이신은 검출되지 않았고, 스트렙토마이신의 경우 23건이 검출되었으며, 아미트라즈(그 대사산물 포함), 코마포스의 경우 각각 10건, 9건의 검출되었다(8). 그러나 기준 설정 후인 본 연구의 모니터링 결과 해당 동물용의약품의 검출율이 현저하게 떨어진 것으로 미루어 볼때 07년 기준 설정 후 설정된 잔류허용기준에 맞춰 관리되고 있음을 알 수 있었다.

LC-MS/MS를 이용한 혈청 중 finasteride 분석 (Determination of finasteride in human serum by LC-MS/MS)

  • 남혜선;남경희;정수희;이장우;강진영;홍순근;김태성;강태석;윤혜정;이광호;이규식
    • 분석과학
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    • 제24권5호
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    • pp.345-351
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    • 2011
  • 본 연구는 LC-ESI-MS/MS를 이용하여 혈청 중의 피나스테라이드의 분석법을 확립하고, 밸리데이션을 통하여 분석방법의 타당도를 검증하였다. 혈청에 내부표준물질로 베클로메타손을 첨가한 후 methyl tert-butyl ether (MTBE)을 사용하여 액체상추출법(liquid-liquid extraction, LLE)으로 전처리하였다. LC-MS/MS의 양이온 모드에서 피나스테라이드와 베클로메타손의 MRM (multiple reaction monitoring) mass transition은 각각 m/z 373.2${\rightarrow}$305.2, m/z 409.3${\rightarrow}$391.2 이었으며, 머무름 시간은 각각 5.81분, 5.46분이었다. 피나스테라이드의 정량한계는 0.1 ng/mL로 나타났으며, 0.1~20.0 ng/mL의 농도 범위에서 검량선은 우수한 직선성($R^2$=0.9997)을 확인할 수 있었으며, 회수율은 80~83% 범위이었다. 피나스테라이드의 일내에 대한 정밀도는 6.3~10.6%, 정확도는 97.3~103.6% 범위이었으며, 연속 3일간 수행한 일간 정밀도는 0.8~5.2%, 정확도는 99.8~102.5%로 나타났다.