• Title/Summary/Keyword: KFDA

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Kernel Fisher Discriminant Analysis for Indoor Localization

  • Ngo, Nhan V.T.;Park, Kyung Yong;Kim, Jeong G.
    • International journal of advanced smart convergence
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    • v.4 no.2
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    • pp.177-185
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    • 2015
  • In this paper we introduce Kernel Fisher Discriminant Analysis (KFDA) to transform our database of received signal strength (RSS) measurements into a smaller dimension space to maximize the difference between reference points (RP) as possible. By KFDA, we can efficiently utilize RSS data than other method so that we can achieve a better performance.

Current Status and Strategies of the Efficacy and Safety Evaluation in Drug Approval Process

  • Park, In-Sook;Park, Chang-Won
    • Proceedings of the PSK Conference
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    • 2003.10a
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    • pp.22-24
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    • 2003
  • This presentation briefly will be introduced on new drug approval process and the review of safety and efficacy of drugs in Korea. First, we will present the regulation related to new drug registration [Regulation of the Efficacy and Safety Evaluation of Drugs, etc (Notification No. 2003-17), Standards for Toxicity Test of Drugs, etc(Notification 1999-61) and GLP Regulation for Nonclinical Laboratory Studies (Notification No. 2000-63)] and the regulation related to clinical trial [Guidelines to Clinical Study Authorization for Drugs (Notification No. 2002-65)] and [Korean Good Clinical Practice(KGCP, Notification No. 1999-67) Regulation]. (omitted)

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Indirect chiral separation of $\alpha$-arylmethylpropionic acids by liquid chromatography

  • Min, Chung-Sik;Jang, Seung-Jae;Choi, Bo-Kyung;Kim, Young-Lim;Jung, Hae-Yun;Bak, Kyung-Min;Lee, Kyung-Hee;Jo, Keang-In;Gu, You-Ni
    • Proceedings of the PSK Conference
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    • 2003.10b
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    • pp.215.1-215.1
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    • 2003
  • A various ${\alpha}$-arylmethylpropionic acids(profen) have been widely used as non-steroidal anti-inflammatory drugs for the relief of acute and chronic rheumatoid arthritis and osteoarthritis, as well as for other connective tissue disorders and pains. Example is fenoprofen, ibuprofen, ketoprofen, and naproxen. All are chiral and, except for naproxen and ibuprofen, are marketed in racemic form. Enantioseparations of profens have been of considerable interest becaus their anti-inflammatory and analgesic effects have been attirbuted almost exclusively to their (S)-enantiomer. (omitted)

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Evaluation of Biogenic Amines in Korean Commercial Fermented Foods (국내 유통 발효식품 중 biogenic amines 함량 분석)

  • Han, Gyu-Hong;Bahn, Kyeong-Nyeo;Son, Yeong-Wook;Jang, Mi-Ran;Lee, Chang-Hee;Kim, So-Hee;Kim, Dae-Byoung;Kim, Seon-Bong;Cho, Tae-Yong
    • Korean Journal of Food Science and Technology
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    • v.38 no.6
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    • pp.730-737
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    • 2006
  • High performance liquid chromatographic methods for the simultaneous determination of 12 biogenic amines were developed and contents of biogenic amines in 23 varieties of Korean commercial fermented food were analyzed. Dansyl derivatives of biogenic amine were very stable and had good peak resolution. Except agmatine, the recovery of biogenic amines from soybean paste with extraction of 0.1 N HC1 added biogenic amines to soybean paste was greater 85%. The calibration curve showed good linearity over a concentration range up to 50 ${\mu}g/mL$. In the determination of biogenic amine level in Korean commercial fermented foods, doenjang and chungkukjang (fermented soybean pastes), soy sauce, anchovy and pacific sand lance liquid jeotkal (fermented fish sauce products), and cabbage kimchi had high level biogenic amines. Especially, traditional doenjang had a histamine (HIS) level of 952.0 mg/kg, a tyramine (TYR) level of 1,430.7 mg/kg. Most cheese had low level of biogenic amines, but one Gouda cheese had a tyramine (TYR) level of 97.5 mg/kg. A low level of biogenic amines was detected in wines, beer, yoghurt, and sausage. Putrescine (PUT), cadaverine (CAD), tryptamine (TRY), histamine (HIS), tyramine (TYR), and 2-phenylethylamine (PHE) were mainly formed in fermented foods by the action of microorganism, so their levels were high with a range. On the other hand, spermidine (SPD), spermine(SPM), serotonin (SER), noradrenaline (NOR), and dopamine (DOP) were formed originally via biosynthesis with consequent low level.

The Effect of Biological Equivalence Examination on Prescribing Practice of Doctors (글리메피라이드 제제의 생물학적동등성 시험이 의사의 처방전발행에 미치는 영향)

  • Jang, Mal-Sook;Choi, Byung-Chul;Yong, Chul-Soon;Choi, Han-Gon;Rhee, Jong-Dal;Yoo, Bong-Kyu
    • Korean Journal of Clinical Pharmacy
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    • v.16 no.2
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    • pp.96-100
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    • 2006
  • Korea Food and Drug Administration (KFDA) has been expediting the Biological Equivalence Examination (BEE) project to encourage generic substitution without expense of inappropriate therapeutic outcome. However, little is known about which considerations are most important in making the decision to prescribe a drug among many generic drugs. The purpose of this survey was to identify how strongly the KFDA certification of BEE influenced doctors when they make a choice between brand and generics of glimepiride preparations. Telephone survey was performed towards doctors working at local clinics by using a questionnaire. Most influential factor to doctors' decision was drug cost followed by pharmaceutical representatives, therapeutic efficacy, and review guideline for reimbursement. Advertisement of the drug was the least influential followed by KFDA certification of BEE. The meaning of BEE was best understood by relatively young doctors with specialty in surgical parts. This survey result further indicated that the doctors considered the therapeutic equivalence examination a preferred measure to expedite generic substitution.

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Safety Assessment of Genetically Modified Foods and Food Additives in Korea

  • Kim, Chang-Min
    • Toxicological Research
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    • v.17
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    • pp.185-188
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    • 2001
  • Genetically modified foods and food additives are derived from organisms that have been inserted foreign genetic materials by recombinant DNA techniques to improve the quality or any other pur-poses. The problems such as toxicity, allergenicity and antibiotics resistance in the safety of genetically modified foods are usually concerned. In Korea, the safety of foods is ensured by the Food Sanitation Act. Although there is no specific provision regarding the genetically modified foods in it, any foods that might cause negative effect(s) on public health or human life are prohibited to sell in the market. In order to systematically evaluate safety of genetically modified foods, the Korea Food and Drug Administration (KFDA) promulgated "Guidelines regarding review of safety assessment data for genetically modified foods and food additives (KFDA Notification 1999-46)". The objectives of these guidelines are to ensure safety of genetically modified foods and food additives. In order to evaluate the safety of genetically modified foods. KFDA operates a special expert committee composed by experts from government, universities, research institutes. and consumer's unions. Recently. manufacturers and consumers are interested in the issues on safety and labeling of genetically modified foods, because of increment of imported genetically modified crops and processed foods. Since government and consumers unions have different viewpoints, their positions regarding the issue are different each other. Therefore, the regulation of labeling on genetically modified foods is prepared and should be enforced at July 2000 in Korea. in Korea.

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Comparison of RPR Card and Mediace RPR test by KFDA Guideline

  • Lee, Hae Soon
    • Korean Journal of Clinical Laboratory Science
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    • v.44 no.3
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    • pp.124-127
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    • 2012
  • Syphilis is an infectious and sexually transmitted chronic disease caused by Treponema pallidum. On the basis of clinical findings, the disease has been divided into a series of overlapping stages, which are used to help guide treatment and follow-up. Persons who have syphilis might seek treatment for signs or symptoms of primary infection, secondary infection and tertiary infection. Latent infections are detected by serologic testing. A presumptive diagnosis of syphilis is possible with the use of two types of serologic tests: nontreponemal tests and treponemal tests assay. The use of only one type of serologic test is insufficient for diagnosis, because each type of test has limitations, including the possibility of false-positive test results in persons without syphilis. KFDA published Koreans guideline of Sexually transmitted infections in 2011. Two hundred samples were tested by RPR card test and Mediace RPR test with simultaneously. The agreement between RPR card test and Mediace RPR test was 95%, the discrepant samples was 5%. The characteristics of 10 discrepant samples was RPR card Positive and Mediace RPR negative nine samples, RPR card negative and Mediace RPR positive one sample. The nine samples were confirmed as FTA-ABS by KFDA guideline of syphilis test algorism, all IgM test was Negative, all IgG test was reactive. So, these cases were past or latent syphilis. The one sample was false-positive reaction.

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