• Title/Summary/Keyword: 신약

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The Study on the Adjustment Methods for Investment Strategies of Government R&D in Field of Drug Development: Focusing on R&D Investment Effects (신약개발 분야 정부 연구개발 투자전략 조정방안 연구: R&D 투자효과를 중심으로)

  • Moon, Kwansik;Hong, Miyoung;Kim, Eun Jeong
    • Journal of Korea Technology Innovation Society
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    • v.18 no.3
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    • pp.444-467
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    • 2015
  • Government has accounted an R&D investment on drug development for the highest share among biotechnology sector. Since competitive investments between each agencies, issues on efficiency or effectiveness of the duplicate investments have been raised continuously. In this research, we investigated the effectiveness of the investment through analysis of portfolio on drug development R&D, journals, patents, and performance of the each process. As a result, reliable technology for current market demands could not compute productive outcome at the early process of the development. On the other hand, grants which support non-clinical process of the development has produced the high-quality patents for active utilization. Moreover, analysis of the performance of the process, which affects rate of success on the drug development, showed decreased efficiency compared to global average. Therefore, we proposed the strategies of reflecting the market demands and bridging between stages without interruption for maximizing the efficiency and effectiveness on investment of drug development R&D. Furthermore, strategies for concentrated support on each process should be prepared for the success of final drug development.

Comparison of Angelica Species Roots Using Taste Sensor and DNA Sequencing Analysis (미각센서와 DNA 염기서열을 이용한 당귀류 비교)

  • Kim, Young Hwa;Choi, Goya;Lee, Hye Won;Lee, Gwan Ho;Chae, Seong Wook;Kim, Yun Hee;Lee, Mi Young
    • The Korea Journal of Herbology
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    • v.27 no.6
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    • pp.37-42
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    • 2012
  • Objectives : Angelica Gigantis Radix is prescribed as the root of different Angelica species on the pharmacopoeia in Korea, Japan and China. Chemical components and their biological activities were also different according to their species. A study for the development of simple method to compare Angelica roots was needed. In order to classify them, the methods such as DNA sequencing analysis and taste sensor were applied to three Angelica species like Angelica gigas, Angelica acutiloba and Angelica sinensis. Methods : PCR amplification of intergenic transcribed spacer (ITS) region was performed using ITS1 and ITS4 primer from nine Angelica roots, and then nucleotide sequence was determined. Taste pattern of samples were measured using the taste-sensing system SA402B equipped with a sensing unit, which consists of artificial lipid membrane sensor probes of anionic bitterness, astringency, saltiness, umami, and cationic bitterness (C00, AE1, CT0, AAE, and AN0, respectively). Results : As a result of comparing the similarity of the ITS region sequences, A. sinensis was discriminated from the others (A. gigas and A. acutiloba). Equally this genetic result, A. gigas and A. acutiloba showed similar taste pattern as compared to A. sinensis. Sourness, bitterness, aftertaste of bitterness, astringency, and aftertaste of astringency of A. sinensis were significantly high as compared with A. gigas and A. acutiloba. In contrast, richness was significantly low. Conclusions : These taste pattern can be used as a way of comparison of Angelica species and this technic could be applied to establish a taste pattern marker for standardization of herbs in various purposes.

Determination of lercanidipine in human plasma by LC-MS/MS (LC-MS/MS를 이용한 혈장 중 레르카니디핀의 분석)

  • Jang, Moon-Sun;La, Sookie;Chang, Kyu Young;Kang, Seung Woo;Han, Sang Beom;Lee, Kyung Ryul;Lee, Hee Joo
    • Analytical Science and Technology
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    • v.21 no.1
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    • pp.34-40
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    • 2008
  • Liquid chromatography-tandem mass spectrometry (LC-MS/MS) method has been developed and validated for the quantitative determination of lercanidipine in human plasma. After addition of internal standard (amlodipine), plasma was precipitated with acetonitrile and the supernatant was evaporated. The residues were dissolved in 50 % acetonitrile and analyzed by LC-MS/MS. Using MS/MS with multiple reaction monitoring(MRM) mode, lercanindipine were selectively detected without severe interference from human plasma. The standard calibration curve for lercanidipine was linear (r = 0.9994) over the concentration range 0.05-20.0 ng/mL in human plasma. The intra- and inter-day precision over the concentration range of lercanidipine was lower than 11.7 % (correlation of variance, CV), and accuracy was between 94.4-114.8 %. This method has been successfully applied to the pharmacokinetic study of lercanidipine in human plasma.

'신약개발'의 마라톤, 우리는 함께 달린다-뉴로제넥스 & 서울대 유전공학특화 창업보육센터

  • Cha, Seung-Jin
    • Venture DIGEST
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    • s.101
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    • pp.56-57
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    • 2006
  • 흔히 인생을 '마라톤'에 비유한다. 스피드보다는 페이스 조절에, 기록보다는 완주 자체에 더 많은 의미를 부여하는 마라톤. 도착점이 보이지 않는 42.195km는 때로는 견디기 힘든 고통을, 그리고 이를 넘어서는 희열을 안겨주기에 드라마가 된다. 벤처에도 '마라톤'이 있다. 바로 평균 12년이란 시간이 걸린다는 신약개발. 그리고 그 척박한 길을 당당한 보폭으로 뛰고 있는 뉴로제넥스와 물심양면으로 돕는 서울대 유전공학특화 창업보육센터. 지금, 이들의 성공 레이스가 막이 오른다.

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임상시험 Guideline(총론)

  • 노재경
    • Proceedings of the Korean Society of Applied Pharmacology
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    • 1994.11a
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    • pp.5-8
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    • 1994
  • 임상시험 guideline은 신약개발을 촉진하기 위하여 약사법 제 26조 제 6항 및 제 24조 제 8호의 규정에 의거하여 신약 임상시험의 안내서로 활용하게 하는데 있다. 임상시험은 특정약의 특정 질환에 대한 임상효과를 판정하기 위하여 시험약의 효과 및 부작용을 윤리적으로 타당한 과학적 시험을 통하여 시행하는 것이다. 특히 임상시험은 사람을 대상으로 하기 때문에 윤리적이고 과학적인 방법을 통하여 시행착오를 최소화하고, 피험자가 위험에 처할 가능성을 최소화하여야 한다.

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약물전달시스템 기술의 개발동향

  • 성하수;최연수
    • Fiber Technology and Industry
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    • v.8 no.2
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    • pp.183-191
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    • 2004
  • 의약품의 원재료인 약물은 사용 목적과 환자에 따라 정(tablet)이나 주사액과 같은 형태를 가지고 이를 제형(dosage form)이라 하고, 이런 형태의 물체를 제제(pharmaceutical preparations)라 한다. 신약이 대거 출현한 1950년대는 새로운 제형을 개발하는 물리약제학(physical pharmacy)이 활발히 연구되었다. 신약들은 당시의 기술로는 생체 내에서의 작용 등에 대한 명확한 자료와 근거 없이 약효가 있을 것으로 추정되었다. 그러나 분석기술과 기기의 발달로 약물의 체내 정량기술이 발달하면서 약물동태 학 (pharmacokinetics)이나 생물 약제학(biopharmaceutics)이 발달하여 약물의 체내 동태를 경시적으로 추적하는 일이 가능해졌다. (중략)

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신약설계를 위한 화합물 DB-chemical Database for Drug Design-

  • Lee, Seong-Gwang;No, Gyeong-Tae
    • Journal of Scientific & Technological Knowledge Infrastructure
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    • s.5
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    • pp.41-50
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    • 2001
  • 화학구조 D B는 그 목적에 다양하게 분류될 수 있는데, 유사한 약효를 검색하기 위한 유사도 검색(similarity search) DB와 유기합성을 위한 reaction DB, 실험이나 계산으로 얻은 물성을 모은 property DB, 생물학적 검증 데이터를 모은 activity DB등이 있다. 이러한 화학 D B는 신약을 설계하는 입장에서 볼 때, 앞에서 말한 다양한 D B로서의 목적을 모두 충족시킬 수 있는 유기적인 설계가 바람직하다.

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