• Title/Summary/Keyword: Korea Food Drug Administration

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Survey and Classification of Pharmaceutical Excipients (국내 의약품 첨가제 정보체계 연구)

  • Park, In-Sook;Park, Sang-Aeh;Kim, Eun-Jung;Park, Hyo-Min;Hong, Chong-Hui;Jnng, Joo-Yeon;Kim, Ho-Jung;Lee, Ji-Hyun;Han, Eui-Sik;Kang, Shin-Jung;Lee, Sun-Hee
    • Journal of Pharmaceutical Investigation
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    • v.36 no.4
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    • pp.239-243
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    • 2006
  • Due to the development of new dosage forms and the improvement or pharmaceutics, the pharmaceutical excipients have become more specified and diverse, and the reclassification on them became necessary. Also with the increasing interests on the kinds and usage amount, related provisions, and evaluation of the pharmaceutical excipients, the systemic and effective control of them was in its demand. Therefore, in this research, we provided the following information on excipients: the type, amount and specification. In order to provide the information, we investigated, analysed and summarized the excipients that are approved by KFDA and published $\ulcorner$Handbook of Pharmaceutical Excipients$\lrcorner$). This handbook is expected to be used as a reference in the development of the pharmaceutics and evaluation in them. As the importance of excipients in pharmaceutics are increasing, IPEC which consist of IPEC-America, IPEC-Europe and JPEC, PDG and ICH have tried to make an international harmonization on excipient. This current status was not an exception to Korea, therefore, the result of this research is expected to make a progress in the evaluation on the excipients to an advanced level.

Development of Dissolution Test Method for Buflomedil Hydrochloride Tablets and Ticlopidine Hydrochloride Tablets (염산부플로메딜 정과 염산티클로피딘 정의 용출시험법 개발)

  • Lee, Ryun-Kyung;Jeong, Gyeong-Rok;Oh, Hyun-Sook;Shim, Jee-Youn;Suh, Sang-Chul;Lee, Hyo-Jung;Kim, Min-A;Park, Seong-Min;Lee, Kyu-Ha;Sohn, Kyung-Hee;Kim, In-Kyu;Sah, Hong-Kee;Choi, Hoo-Kyun;Cho, Tae-Yong;Hong, Choong-Man
    • YAKHAK HOEJI
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    • v.56 no.4
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    • pp.211-216
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    • 2012
  • Drug dissolution test has been used for the purpose of both quality control of solid oral dosage forms and predicting in vivo drug release profiles. In this study, the dissolution profiles of buflomedil hydrochloride tablets and ticlopidine hydrochloride tablets were investigated according to the "Guidelines on Specifications of Dissolution tests for Oral dosage forms" of Korean Pharmacopoeia (KP). The analytical method using HPLC was validated. The validation was performed in terms of specificity, linearity, accuracy, precision and limit of quantitation.

Prevalence of Nutrition Labeling and Claims on Processed, and Packaged Foods (시판 가공식품의 영양표시 실태 조사)

  • Kwon, Kwang-Il;Park, So-Hyun;Lee, Jun-Hyung;Kim, Jee-Young;Yoo, Kwang-Soo;Lee, Jee-Sun;Kim, Seo-Young;Sung, Hyun-I;Nam, Hye-Seon;Kim, Jong-Wook;Lee, Hye-Young;Park, Hye-Kyung;Kim, Myung-Chul
    • Korean Journal of Community Nutrition
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    • v.12 no.2
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    • pp.206-213
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    • 2007
  • This study investigated the prevalence of nutrition labeling and claims on processed and packaged foods. The final database consists of 1,287 foods, which were collected in two supermarkets in the Seoul area from September to November, 2006. An estimated 78% of KFDA-regulated processed, and packaged foods have nutrition labels. Nutrient content claims on food labels were identified in 21% of the foods which have nutrition labels. The prevalence of nutrition labels in this study is much higher than in previous studies due to the current expansion of the mandatory labeling regulation. However, false labeling and misleading contents claims were also identified. The food label is an important tool for enhancing the public's understanding of healthy choices of processed foods. Therefore, to maximize the benefits of the nutrition labeling regulation, industries, government agencies and health professionals should work together to help consumers make healthy dietary choices and improve their health.

Development of a Quantitative Analytical Method for Determining the Concentration of Human Urinary Paraben by LC-MS/MS

  • Lee, Seung-Youl;Son, Eunjung;Kang, Jin-Young;Lee, Hee-Seok;Shin, Min-Ki;Nam, Hye-Seon;Kim, Sang-Yub;Jang, Young-Mi;Rhee, Gyu-Seek
    • Bulletin of the Korean Chemical Society
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    • v.34 no.4
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    • pp.1131-1136
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    • 2013
  • Parabens, the esters of p-hydroxybenzoic acid, have been widely used as antimicrobial preservatives in cosmetic products, drugs, and processed foods and beverages. However, some parabens have been shown to have weak estrogenic effects through in vivo and in vitro studies. Because such widespread use has raised concerns about the potential human health risks associated with exposure to parabens, we developed a simultaneous analytical method to quantify 4 parabens (methyl, ethyl, propyl, and butyl) in human urine, by using solid-phase extraction and high-performance liquid chromatography coupled with triple quadrupole mass spectrometry. This method showed good specificity, linearity ($R^2$ > 0.999), accuracy (92.2-112.4%), precision (0.9-9.6%, CV), and recovery (95.7-102.0%). The LOQs for the 4 parabens were 1.0, 0.5, 0.2, and 0.5 ng/mL, respectively. This method could be used for quick and accurate analysis of a large number of human samples in epidemiological studies to assess the prevalence of human exposure to parabens.

METHAMPHETAMINE-INDUCED CYTOTOXICITY IN HUMAN SEROTONERGIC CELLS

  • Kim, Kyu-Bong;Suh, Soo-Kyung;Lee, Bo-Kyung;Park, Chang-Won;Seo, Kyung-Won;Kim, Jong-Won;Kim, Kwang-Jin;Kim, Jae-Hee;Park, Chan-Woong
    • Proceedings of the Korean Society of Toxicology Conference
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    • 2002.11b
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    • pp.190-190
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    • 2002
  • Methamphetamine (META) is a psychostimulant and has become popular recreational drug of abuse in many countries. The neurotoxic damage caused by METH is characterized by degeneration of the dopaminergic and serotonergic systems in striatum and hippocampus.(omitted)

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KFDA Postal Dose Audit System

  • Lim, Chun-Il;Ahn, Ji-Young;Lee, Hyun-Koo;Jeong, Hee-Kyo;Oh, Heon-Jin
    • Proceedings of the Korean Society of Medical Physics Conference
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    • 2006.08a
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    • pp.12-12
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    • 2006
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