• Title/Summary/Keyword: new drug

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Status of Worldwide Regulations on Scientific Data for the Registration of Drugs for Human Uses & Advisory Committees(I) (외국(外國)의 의약품허가신청첨부자료(醫藥品許可申請添付資料) 및 자문기구(諮問機構)의 현황(現況) ( I ))

  • Yong, Kun-Ho
    • Journal of Pharmaceutical Investigation
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    • v.10 no.3
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    • pp.51-77
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    • 1980
  • A comparison of worldwide drug registration requirements on scientific data required by the different regulatory authorities for the investigational new drug and new drug application for human uses was briefly reviewed and as one of administrative processings on review and evaluation of applications, the functions of scientific advisory committees were reviewed.

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Establishment of new cytotoxicity screening system using Caco-2 cells

  • Seok, Ji-Eun;Kim, Ki-Hwan;Kim, Dong-Chool
    • Proceedings of the PSK Conference
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    • 2002.10a
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    • pp.92-93
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    • 2002
  • With the recent development of combinatorial chemistry, recombinant biotechnology and rational drug design, millions of compounds are being produced in the laboratories of pharmaceutical companies. These new drug candidates are evaluated their efficacy and toxicity through in vivo animal model studies which is very important in drug development. From these studies, very successful drug candidates are selected. (omitted)

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Studies on Excipients for oral dosage forms of currently marketed drug products

  • Kang, Shin-Jung;Choi, Hyun-Ceol;Kim, Ho-Jeong;Park, Sang-Aeh;Kim, Ji-Sun;Kim, Tae-Hee
    • Proceedings of the PSK Conference
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    • 2003.04a
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    • pp.303.1-303.1
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    • 2003
  • Excipients of the drug products can sometimes affect the rate and extent of drug absorption. The changes in components or composition of them can also affect the pharmacological activity. So the quantity of excipients to be changed, the new excipients and atypically large amount of commonly used excipients should be considered as bioequivalence studies. (omitted)

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Silica Induces Nuclear Factor-kB Activation through TAK1 and NIK in Rat2 cell line

  • Young Lim;Nam, Hae-Yun;Rha, Suk-Joo;Kim, Young-Hoon;Cho, Yong-Yeun;Yang, Ki-Hwa;Kim, Kyoung-Ah;Lee, Kweon-Haeng
    • Proceedings of the Korean Society of Toxicology Conference
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    • 2003.05a
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    • pp.75-75
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    • 2003
  • Silica has been known to be a factor in acute cell injury and chronic pulmonary fibrosis. In Rat2 fibroblasts, silica induced the activation of NFkB, which plays a crucial role in regulating the expression of many genes involved in the subsequent inflammatory response. In addition, we observed that TAK1 and NIK were involved in silica-mediated NF-kB activation in Rat2 cells. (omitted)

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Biodegradable polymeric drug delivery systems

  • Jeong, Seo-Young;Kim, Sung-Wan
    • Archives of Pharmacal Research
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    • v.9 no.2
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    • pp.63-73
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    • 1986
  • The use of biodegradable polymetric materials as drug carriers is a relatively new dimension in polymeric drug delivery systems. A number of biodegradable or bioerodible polymers, such as poly(lactic/glycolic acid) copolymer, poly($\alpha$-amino acid), polyanhydride, and poly (ortho ester) are currently being investigated for this purpose. These polymers are useful for matrix and reservoir-type delivery devices. In addition, when chemical functional groups are introduced to the biodegradable polymer backdone, such as poly (N-(2-hydroxypropyl) methacrylamide), the therapeutic agent can be covalently bound directly or via spacer to the backbone polymer. These polymer/drug conjugates represent another new dimension in biodegradable polymeric drug delivery systems. In addition, examples of biodegradable polymeric durg delivery systems currently being investigated will be discussed for the purpose of demonstrarting the potential importance of this new field.

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Novel Approaches for Efficient Antifungal Drug Action

  • Lee, Heejeong;Lee, Dong Gun
    • Journal of Microbiology and Biotechnology
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    • v.28 no.11
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    • pp.1771-1781
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    • 2018
  • The emergence of multidrug-resistant microorganisms, as well as fungal infectious diseases that further threaten health, especially in immunodeficient populations, is a major global problem. The development of new antifungal agents in clinical trials is inferior to the incidence of drug resistance, and the available antifungal agents are restricted. Their mechanisms aim at certain characteristics of the fungus in order to avoid biological similarities with the host. Synthesis of the cell wall and ergosterol are mainly targeted in clinical use. The need for new approaches to antifungal therapeutic agents or development alternatives has increased. This review explores new perspectives on mechanisms to effectively combat fungal infections and effective antifungal activity. The clinical drug have a common feature that ultimately causes caspase-dependent cell death. The drugs-induced cell death pathway is associated with mitochondrial dysfunction, including mitochondrial membrane depolarization and cytochrome c release. This mechanism of action also reveals antimicrobial peptides, the primary effector molecules of innate systems, to highlight new alternatives. Furthermore, drug combination therapy is suggested as another strategy to combat fungal infection. The proposal for a new approach to antifungal agents is not only important from a basic scientific point of view, but will also assist in the selection of molecules for combination therapy.

Pharmacokinetic Study on DWC-751, a New Cephalosporin, in Rats and Mice (신규 세파로스포린계 항생물질 DWC-751의 흰쥐 및 생쥐 체내동태)

  • 심창구;최은진;이성원;박남준;강영숙;유영효
    • Biomolecules & Therapeutics
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    • v.1 no.2
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    • pp.204-210
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    • 1993
  • The distribution and excretion of DWC-751, a new cephalosporin, were examined in rats and mice following a single intravenous administration. DWC-751 in plasma and urine was determined by both HPLC and microbiological assay. The plasma concentration of the drug declined biexponentially. The initial and terminal half lives of the drug were 3.0 and 28.3 min, respectively. Binding of the drug to plasma proteins was 42.3%. The distribution volume at steacly-state ($Vd_{ss}$) was only 0.341 ι/kg, which is well correlated with the low n-octanol/water partition coefficient of the drug ($K_{o/w{\cong}0$) Actually, the drug was distributed to liver, kidney and lung with very low organ/plasma concentration ratio. The drug, was excreted mainly via renal excretion, i.e., the total($CL_T$) and apparent renal($CL_{R}$) clearances of the drug were 10.8 and 7.5 ml/min/kg, respectively.

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Identification of a new analogue of sildenafil from functional food for penile erectile dysfunction

  • Shin, Myoung-Hee;Hong, Moo-Ki;Lee, Young-Ja;Kim, Woo-Sung;Hong, Ki-Hyung;Jung, Yeon-Chan;Kim, In-Bok
    • Proceedings of the PSK Conference
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    • 2002.10a
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    • pp.234.1-234.1
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    • 2002
  • Any food additive as a chemical synthetic compound. whose criteria and standards are not notified publicly and foods using an food additives containing such a chemical synthetic compound or foods containing it shall not be sold. or manufactured. imported. processed. used. prepared. stored. transported. or displayed for the purpose of sale. Some food manufacturers have illegally added drugs to foods not notifying this. Moreover. structure-modified new drugs could be added. But it is almost impossible to detect these by ordinary laboratory inspection. Thus the study about the identification of analogues of pending drugs is imminent. (omitted)

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