• 한국산학기술학회논문지
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• 제19권5호
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• pp.389-398
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• 2018

상호인정협약(MRA)은 무역기술장벽(TBT) 극복을 위한 WTO 틀 내의 중요한 정책수단이다. MRA의 경제적 효과와 관련된 연구는 대부분 인터뷰와 간단한 설문조사를 통해 그 효과를 확인하거나 MRA체결을 통해 면제되는 제품의 심사비용이 명확하고 계량분석이 가능한 데이터가 축적된 정보통신산업 등에서 제한적으로 계량 분석을 통해 비용절감 효과와 수출에 미치는 영향을 제시한다. 이러한 연구결과는 모두 MRA 체결이 긍정적 경제효과를 가져오는 것으로 분석되었다. 그러나 제약 산업의 MRA체결에 대해 직접 경제적 효과를 분석한 연구는 없다. 따라서 본 논문에서는 EFTA와의 GMP 실사 면제 MRA체결의 경제효과를 비시장재의 가치 추정 방법인 조건부가치평가법(CVM)을 통해 분석하였다. 먼저 제약 기업을 대상으로 EFTA권역과의 MRA 체결 의의와 효과를 설명하고, 가상의 시장을 설정하여 GMP 실사 면제에 대한 연회비 형태의 지불의사를 이중경계양분형질문을 통해 조사하였다. 이를 Hanemann(1984)이 제시한 효용차이모형을 통해 중간값 WTP와 절단된 평균 WTP를 산출하였고, 이를 바탕으로 전체기업의 경제효과를 산출한 결과 연간 최소 70.3억에서 최대 약 158억의 경제적 효과가 있는 것으로 분석되었다.

• 자원환경지질
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• 제48권3호
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• pp.221-229
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• 2015

약학 분야에서 점토광물은 점토광물 자체의 약리작용을 확인하고 원료의약품으로 활용하거나 희석제, 유화제, 점증제, 활택제 등 의약품 제형의 완성도를 높이는 첨가제로서 사용되고 있다. 벤토나이트(Bentonite), 카올린(Kaolin), 규산알루민산마그네슘(Magnesium aluminum silicate), 탤크(Talc) 등은 원료의약품 혹은 첨가제로서 활용 가능한 대표적인 점토 광물로 국내외 의약품 공정서에 수재되어 있고, 약학적 활용시 의약품등급으로 규제되고 있다. 본 논문에서는 공정서에 수재된 점토 광물을 중심으로 공정서의 규격을 확인하고, 점토광물의 특성 및 원료의약품 혹은 의약품 첨가제로서의 점토 광물에 대한 활용 사례를 소개하고자 한다. 결론적으로 점토광물을 제약산업에 활용하는 것은 점토광물의 고부가가치화를 위한 한 가지 방법이 될 수 있으며, 자원의 개발 및 활용이라는 측면에서 매우 유용할 것이라 사료된다.

• KSBB Journal
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• 제32권3호
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• pp.169-173
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• 2017

Butyric acid (C4 carboxylic acid) is used as an important compound in food, pharmaceutical, and chemical industries. Currently, butyric acid is mainly produced at the industrial scale through the petrochemical processes. Bio-based butyric acid has also gained attention, because the consumer prefers the food and pharmaceutical ingredients that are produced through fermentation. Clostridia is one of the well-known butyric acid producers, and massively engineered for enhanced production of butyric acid. In this paper, we reviewed the metabolic pathway of clostridia, especially Clostridium acetobutylicum and Clostridium tyrobutyricum, and summarized the metabolic engineering strategies of the strains for enhanced production of butyric acid.

• 대한약학회:학술대회논문집
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• 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-2
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• pp.179.1-179.1
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• 2003

Chiral building blocks have the importance in the pharmaceutical and agrochemical industries as well as in the development of rapid and efficient syntheses of bioactive compounds and natural product. Vinylstannane contains two synthetically useful functional groups (vinylstannane and allylic alcohol). The vinylstannane functional group can be used in C-C bond formation under a variety of conditions and the allylic alcohol functional can be used in hydroxyl-directed epoxidations, cyclopropanations, and sigmatropic rearrangements. (omitted)

• 분석과학
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• 제22권1호
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• pp.35-43
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• 2009

단순히 완제품만을 평가하는 기존의 방법에서 제조 공정의 보다 깊은 이해와 공정 제어를 통한 품질 확보가 PAT (공정분석기술, process analytical technology)가 지향하고 있는 핵심이다. 생산 상 위험 요소가 많이 발생하는 공정을 제어할 수 있는 목적으로 새로운 실시간 공정 제어 기술을 개발하는 것이 PAT 연구 내용이다. 공정 단계에 대한 이해, 공정에 필요한 여러 가지 변수 및 공정 생산품의 평가 기술은 PAT를 수행하기 위한 기술적 핵심 요소이다. 이에 관련하여 다국적 제약회사의 실제 공정에서의 실시간 품질관리 사례는 상당히 많은 것으로 알려져 있으나, 제조공정 및 분석 기술 자체가 기업 비밀인 경우가 많아 관련 정보는 극히 제한되어 있다. 본 총설을 통하여 실제 제약 산업 현장에서 활용되고 있는 적용사례를 소개하고, 각 제조 공정 및 완제품 실시간 품질 관리를 위한 PAT 연구 사례 및 기술개발 현황에 대하여 언급하고자 한다.

• 품질경영학회지
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• 제22권4호
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• pp.102-110
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• 1994

We investigate the small-sample behavior of the probability of rejection curves and its performance for a equivalence testing procedure based on confidence intervals which was developed with a motivation from bioequivalence studies. This type of equivalence studies are conducted frequently in pharmaceutical industries to compare the relative bioavailabilty of two formulations of a drug and can be applied various fields where assurance of quality equivalence is needed. From the Monte-Carlo simulation results we suggest proper sample sizes for the equivalence testing procedure.

• 한국식품영양학회지
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• 제13권2호
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• pp.171-175
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• 2000

Microbial proteases have certain unique characteristics, and are now widely used in food, leather, detergent, and pharmaceutical industries. Thermophilic Actinomyces producing the protease was isolated from soil in Wonju city. This strain was able to grow and produce protease at the culture temperature of 50$^{\circ}C$. The maximum protease production was obtained when 0.5% soluble starch and 0.4% yeast extract were used as carbon and nitrogen source, respectively. The other culture condition for the maximal productivity of the protease was 0.1% K2HPO4, and 0.05% CaCl2 at initial pH 8.0 for 48 hours.

• Journal of Plant Biotechnology
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• 제37권1호
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• pp.67-71
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• 2010

Output traits centered on improved plant-based products will find their way to consumers in such ways as nutritionally enhanced foods, therapeutic proteins for disease treatment and vaccines, bio-industrial products, modified oil quality and biofuels. Significant progress in biotechnology has occurred over the last several decades. The importance of output traits development and production using biotechnology will impact not only agribusiness, but also pharmaceutical and food industries. The objective of this paper is to review briefly the current status of output traits development in crop plants using nutrients and pharmaceuticals as examples.

• International Journal of Contents
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• 제9권2호
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• pp.38-47
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• 2013

We examine whether the attributes of patented knowledge have any impact on its chances of commercialization. It has been hypothesized that the scope and cumulativeness of patented knowledge would positively affect the likelihood of its commercialization. The hypotheses were tested using patents data on the US biotechnology and pharmaceutical industries. We found support for the prediction that the scope of patented knowledge increases the likelihood of commercialization, but we didn't find support for the cumulativeness aspect. These findings have important implications for firms that develop patentable knowledge, license-out patents, license-in patents from external sources, or debate about patenting strategy.

• Bulletin of the Korean Chemical Society
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• 제30권9호
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• pp.2021-2026
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• 2009

Toluene, xylene and styrene are volatile organic solvents that are commonly used in mixtures in many industries. Because these solvents are metabolized and then excreted in urine, their urinary metabolites are thought to be biomarkers of occupational exposure to these solvents. Therefore, a simple, rapid, and yet reliable analytical method for determining the metabolites is required for accurate biological monitoring. In the present study, a simple and rapid HPLC-UV method was developed for the simultaneous determination of eight major metabolites of toluene, xylene and styrene: hippuric acid (HA), mandelic acid (MA), o-, m- and p-methylhippuric acids (o-, m- and p-MHAs), and o-, m- and p-cresols. A monolithic column was employed as the stationary phase and several conditions, including flow rate, composition of mobile phase and column temperature, were variables for the optimization of the chromatographic resolution. All eight metabolites were successfully resolved within 5 minutes in 10% aqueous ethanol containing 0.3% acetic acid and 1.6% $\beta$-cyclodextrin, using a flow rate gradient of 1.0 - 5.0 mL/min at 25 ${^{\circ}C}$. The performance of this method was validated by linearity, intra- and inter-day accuracy, and precision. The linearity was observed with correlation coefficients of 0.9998 for HA, 0.9999 for MA, 0.9989 for o-MHA, 0.9998 for m-MHA, 0.9991 for p-MHA, 0.9997 for o-cresol, 0.9998 for m-cresol, and 0.9986 for p-cresol. The intra- and inter-day precision of the method were less than 5.89% (CV) and the accuracy ranged from 92.95 to 106.62%. The validity was further confirmed by analysis of reference samples that were prepared by the inter-laboratory quality assurance program of the Korea Occupational Safety and Health Agency (KOSHA, Seoul, Korea). All measured concentrations of the analytes agreed with the certified values.