• Title/Summary/Keyword: Drug

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The Quality Regulation of Drug Excipients (의약품첨가물과 규격관리)

  • Choi, Myoeng-Sin;Hong, Chong-Hui;Jang, Seung-Jae;Kang, Chan-Soon
    • Journal of Pharmaceutical Investigation
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    • v.33 no.1
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    • pp.67-71
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    • 2003
  • Drug excipients are material used in the formulation of pharmacologically active drugs. They have a variety of roles including dilutents/fillers/bulking agents, binders/adhesives, propellant, disintegrants, lubricants/dlidants, colors, flavors, coating agents, polising agents, fragrance, sweeteening agent, polymers and waxes. Excipient should be inert or inactive and does not interfere with the test. Nowadays within industry there has been a recent surge of interest in novel excipient for novel dosage forms. The purpose of the review is to introduce the administration systems of drug excipient about kinds, matters to be attended to change of excipients.

Point to Consider on the Evaluation of Safety and Efficacy of Dna Vaccine

  • Kim, Jong-Won;Kang, Ju-Hye;Han, Eui-Sik;Park, Chang-Won;Na, Han-Kwang;Kim, Kwang-Jin;Kim, Kyu-Bong;Kim, Jae-Hee;Cho, Mi-Young;Nam, Kyung-Tak;Kim, Tae-Gyun;Hong, Seung-Hwa;Kim, Seung-Hee;Chung, Hye-Joo;Lee, Sun-Hee;Kang, Seog-Youn
    • Proceedings of the Korea Environmental Mutagen Society Conference
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    • 2004.05a
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    • pp.122-122
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    • 2004
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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.

Development and validation of an analytical method for the quantification of 2,6-diisopropylnaphthalene in agricultural products using GC-MS/MS

  • Lee, Han Sol;Park, Ji-Su;Lee, Su Jung;Shin, Hye-Sun;Chung, Yun mi;Choi, Ha na;Yun, Sang Soon;Jung, Yong-hyun;Oh, Jae-Ho
    • Analytical Science and Technology
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    • v.34 no.1
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    • pp.1-8
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    • 2021
  • An analytical method was developed and optimized for the quantification of a plant growth regulator, 2,6-diisopropylnaphthalene (2,6-DIPN), in agricultural products using gas chromatography-tandem mass spectrometry. The samples were extracted, partitioned, and were purified using a Florisil® cartridge. To validate the analytical method, its specificity, linearity, limit of detection (LOD) and limit of quantification (LOQ) of the instrument, LOQ of the analytical method (MLOQ), accuracy, and repeatability were considered. The method displayed excellent results during validation, and is suitable for the determination and quantification of the low residual levels of the analyte in the agricultural samples. All of the results with the optimized method were satisfactory and within the criteria ranges requested in the Codex Alimentarius Commission guidelines and the Ministry of Food and Drug Safety guidelines for pesticide residue analysis. The developed method is simple and accurate and can be used as a basis for safety management of 2,6-DIPN.

Evaluation of Adverse Drug Properties with Cryopreserved Human Hepatocytes and the Integrated Discrete Multiple Organ Co-culture (IdMOCTM) System

  • Li, Albert P.
    • Toxicological Research
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    • v.31 no.2
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    • pp.137-149
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    • 2015
  • Human hepatocytes, with complete hepatic metabolizing enzymes, transporters and cofactors, represent the gold standard for in vitro evaluation of drug metabolism, drug-drug interactions, and hepatotoxicity. Successful cryopreservation of human hepatocytes enables this experimental system to be used routinely. The use of human hepatocytes to evaluate two major adverse drug properties: drug-drug interactions and hepatotoxicity, are summarized in this review. The application of human hepatocytes in metabolism-based drug-drug interaction includes metabolite profiling, pathway identification, P450 inhibition, P450 induction, and uptake and efflux transporter inhibition. The application of human hepatocytes in toxicity evaluation includes in vitro hepatotoxicity and metabolism-based drug toxicity determination. A novel system, the Integrated Discrete Multiple Organ Co-culture (IdMOC) which allows the evaluation of nonhepatic toxicity in the presence of hepatic metabolism, is described.

Pharmacodynamic Drug-Drug Interactions Considered to be Added in the List of Contraindications with Pharmacological Classification in Korea (약물군-약물군 조합으로 도출한 약력학적 기전의 추가 병용금기성분)

  • Je, Nam Kyung;Kim, Dong-Sook;Kim, Grace Juyun;Lee, Sukhyang
    • Korean Journal of Clinical Pharmacy
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    • v.25 no.2
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    • pp.120-129
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    • 2015
  • Objectives: Drug utilization review program in Korea has provided 'drug combinations to avoid (DCA)' alerts to physicians and pharmacists to prevent potential adverse drug events or inappropriate drug use. Seven hundred and six DCA pairs have been announced officially by the Ministry of Food and Drug Safety (MFDS) by March, 2015. Some DCA pairs could be grouped based on the drug interaction mechanism and its consequences. This study aimed to investigate the drug-drug interaction (DDI) pairs, which may be potential DCAs, generated by the drug class-drug class interaction method. Methods: Eleven additive/synergistic and one antagonistic drug class-drug class interaction groups were identified. By combining drugs of two interacting drug class groups, numerous DDI pairs were made. The status and severity of DDI pairs were examined using Lexicomp and Micromedex. Also, the DCA listing rate was calculated. Results: Among 258 DDI pairs generated by the drug class-drug class interaction method, only 142 pairs were identified as official DCA pairs by the MFDS. One hundred and four pairs were identified as potential DCA pairs to be listed. QT prolonging agents-QT prolonging agents, triptans-ergot alkaloids, tricyclic antidepressants-monoamine oxidase inhibitors, and dopamine agonists-dopamine antagonists were identified as drug class-drug class interaction groups which have less than 50 % DCA listing rate. Conclusion: To improve the clinicians' adaptability to DCA alerts, the list of DCA pairs needs to be continuously updated.

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.