• 한국시스템다이내믹스연구
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• 제6권2호
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• pp.53-71
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• 2005

In the short view, the medical fee regulation has contributed for patients by reducing their hospital expenses and helping them to visit hospital more easily. But, some medical parts have gone into red ink because the medical fee has been different with each item. So, that medical parts have been experienced the medical specialist shortage. And some hospitals have been interested in high-priced medical services to cover their deficit. Moreover, most medical doctors don't need to use low-priced medicine undergo these circumstance, domestic small and medium pharmaceutical company has been going into bankruptcy and the dependence on foreign drug company has been rising. If these abnormal medical service keep to patience, people will get more burden of medical fee cause 9 casual loop work very complicated. In other words, present medical fee regulation were made by some politicians who had plain thinking. Those who govern the people, therefore, stand for not present medical service user but the welfare and health promotion of people and give attention to desirable medical fee with systems thinking.

• 한국독성학회:학술대회논문집
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• 한국독성학회 2002년도 Molecular and Cellular Response to Toxic Substances
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• pp.199-200
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• 2002

GX-12 is a naked DNA vaccine developed by research team of Dong-A Pharmaceutical Company, Green Cross Company and Genexine for the treatment of HIV infection. It consists of four separate plasmids (pGX10-GE HX, pGX10-dpol JR, pGX10-VN/TV JR, pGX10-hIL-12m), which were constructed by inserting the HIV-1 gag-env, pol, regulatory genes and a human IL-12 mutant gene into pGX10 plasmid vectors.(omitted)

• 기술혁신학회지
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• 제20권2호
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• pp.313-333
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• 2017

과학기술이 고도화, 전문화, 대형화됨에 따라 연구개발에 수반되는 비용과 위험을 최소화하거나 분산시키기 위해 물질이전계약 기술이전계약과 같은 특허라이선싱을 통한 상호협력이나 공동연구개발이 활발해지고 있다. 연구 개발에 있어 이러한 공동작업은 목표달성에 있어서 효율적인 자원 및 인력 등의 배분을 통한 분업의 효과를 달성할 수 있지만, 필연적으로 기존 선행특허를 활용한 개량발명의 귀속과 활용, 즉 후속연구나 공동연구로 진행된 성과물인 지식재산권의 귀속과 활용에 대해서는 많은 분쟁 가능성이 있다. 이 논문에서 살펴본 사례는 최근 개량발명과 관련하여 주목할 만한 판결로써 대학에서 보유한 특허의 완성기술에 대해 제약회사에서 기술이전을 전제로 시험이나 평가를 수행한 후, 독성을 이유로 계약을 파기하여 대학에서 기업을 상대로 계약위반에 따른 손해배상청구소송을 제기한 건이다. 즉 신약후보물질을 개발한 대학과 후속 기술이전을 협의하는 제약사 간의 분쟁사례로서 원천특허의 개량발명에 대하여 선행특허의 보호와 연구계약, 나아가 연구성과 보호를 위한 연구보안의 측면에서 많은 시사점을 주는 사례라고 생각된다. 이 논문에서는 대상판결을 살펴보고, 개량특허와 원천기술의 보호에 대해 살펴보며, 판결에 대한 평석으로써 이 사건 판결의 주요 쟁점을 정리한 후 개량특허탈취 관련 특허권침해판단기준 등에 대해 살펴보고자 한다. 이후 이 사건 판결을 통한 시사점 및 향후 대응전략 등에 대해서 제언하고자 한다.

• Archives of Pharmacal Research
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• 제25권5호
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• pp.647-651
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• 2002

An LC/MS/MS method for the simultaneous determination of a neuroprotective agent for ischemia-reperfusion damage, KR-31378 and its N-acetyl metabolite KR-31612 in human plasma was developed. KR-31378, KR-31612 and the internal standard. KR-31543 were extracted from human plasma by liquid-liquid extraction. A reverse-phase HPLC separation was performed on Luna phenylhexyl column with the mixture of acetonitrile-5 mM ammonium formate (55:45, v/v) as mobile phase. The detection of analytes was performed using an electrospray ionization tandem mass spectrometry in the multiple reaction monitoring mode. The lower limits of quantification for KR-31378 and KR-31612 were 2.0 ng/ml. The method showed a satisfactory sensitivity, precision, accuracy, recovery and selectivity.

• 약학회지
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• 제55권5호
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• pp.426-431
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• 2011

This study was performed to investigate the current regulatory guidances of safety and efficacy evaluation for the development and approval of stereoisomeric drugs in US, EU, Canada and Japan. The important categories for the development of stereoisomeric drugs are classified as 1) development of a single enantiomer as a new active substance 2) development of a racemate as a new active substance 3) development of a new single enantiomer from an approved racemate. The regulatory documents adopted in major countries for the safety and efficacy evaluation of stereoisomeric drugs were investigated with the focus on three major categories mentioned above. For the regulatory approval of stereoisomeric drugs in Korea, it is expected that the investigated results obtained in this study will be useful for the basic materials to ensure the safety and efficacy of stereoisomeric drugs as well as the stereochemical issues in chiral drug development in domestic pharmaceutical company.

• Journal of Pharmaceutical Investigation
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• 제31권2호
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• pp.89-94
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• 2001

The pharmacokinetics of recombinant human granulocyte colony stimulating factor (rhG-CSF) following intravenous (i.v.), intramuscular (i.m.) and subcutaneous (s.c.) administration of HM1041l-lyo and HM10411-liq (lyophilized and liquid formulations of rhG-CSF, recently under development by Hanmi Pharmaceutical Company) were studied in rats, and compared with that of Filgrastim (conventional formulation of rhG-CSF on market). The plasma concentration of rhG-CSF was quantified using a specific ELISA. The pharmacokinetic parameters of rhG-CSF, after i.v., i.m. and s.c. administration of Filgrastim, HM1041l-lyo and HM1041l-liq to rats at a rhG-CSF dose of $10\;{\mu}g/kg$, were almost identical among the three formulations. No dose-dependency was observed in the pharmacokinetic parameters of rhG-CSF following i.v. administration in the dose range of $5{\sim}100\;{\mu}g/kg$. rhG-CSF, after i.v. administration of the three preparations at a dose of $10\;{\mu}g/kg$ to rats, was detected at low levels in all of the body tissues with highest tissue/plasma ratio of $0.46{\sim}0.51$ for the kidney at 30 min after the administration. The pharmacokinetics of rhG-CSF, after i.v. administration to mice at a dose of $10\;{\mu}g/kg$, were comparable among the three formulations. In conclusion, HM10411-lyo and HM10411-liq exhibited similar pharmacokinetics for rhG-CSF with Filgrastim regandless of animal species. Considering the fact that HM10411 series, contrary to Filgrastim, are proteins lacking a methionine residue, the methionine moiety in rhG-CSF molecule does not appear to influence the pharmacokinetics of the protein significantly.

• 한국산학기술학회논문지
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• 제19권10호
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• pp.490-497
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• 2018

본 연구는 국내 상장제약기업을 대상으로 치료제 질환분야의 다각화 결정요인에 대해 분석함으로써, 최근 화두가 되고 있는 치료제 질환분야에서의 전문화 또는 다각화 전략을 결정짓는 요인이 무엇인지 살펴보았다. 본 연구에서는 자산규모, 매출액, 수익성, 성장성 등 요인들을 설정하고 추가적으로 영업적인 특징을 나타내는 요인인 판매관리비율과 직원 수를 추가하여 이들이 다각화 전략에 어떠한 영향을 미치는지 확인하였다. 연구방법에서는 각 요인들이 다각화에 영향을 미치기까지 걸리는 시간을 감안하여 t-1부터 t-4까지의 시차를 고려하여 변수들을 추가하는 전진선택법 회귀분석을 시행하였다. 총 6가지 요인 중 자산규모와 직원 수, 수익성이 t-1의 시점에서 성장성은 t-2시점에서 다각화의 결정에 유의한 영향을 미쳤다. 국내 상장제약기업들은 자산규모가 클수록, 높은 수익성과 성장성을 가질수록 오히려 소수의 질환분야로 집중화하는 경향을 보였고, 직원 수가 많을수록 다양한 질환분야에 진출하였다. 이는 한 분야의 전문화를 위한 깊이 있는 연구개발의 투자를 위해서는 큰 자산규모와 수익성 및 성장성이 뒷받침이 되어야하기 때문일 것으로 생각된다. 본 연구는 국내 제약기업들이 경쟁력 있는 기업으로 나아가기 위해 자신에게 맞는 다각화 또는 전문화 전략을 세우는데 유용한 정보를 제공할 것으로 기대된다.

• 약학회지
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• 제53권5호
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• pp.293-297
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• 2009

The abuse of methamphetamine (MA) is one of the most serious drug abuses in Asia. And, the prevention of precursor production for abuse drug is one of the most effective drug control system. Isotope ratio analysis at natural abundance levels have been used to establish the environmental source or the geographic origin of various biological and nonbiological materials. Ephedrine, the precursor of MA, is produced by one of three methods; extraction from Ephedra plants, full chemical synthesis or via a semi-synthetic process involving the fermentation of sugar, followed by amination. We investigated the origin of ephedrine and pseudoephedrine based on the carbon and nitrogen values for nineteen pharmaceutical powder materials (PPMs) obtained from pharmaceutical company in Korea by stable isotope ratio mass spectrometry coupled to an elemental analyser (EA-IRMS). The carbon delta values for the ephedrine and pseudoephedrine were -24.21~-22.72 (mean=-23.72) $^{\cir}/_{\circ\circ}$ and -23.79~-22.71 (mean=-23.48) $^{\cir}/_{\circ\circ}$. The nitrogen delta values were 3.51~5.55 (4.43) $^{\cir}/_{\circ\circ}$ and 2.24~8.22 (5.42) $^{\cir}/_{\circ\circ}$. These results indicate that PPMs are semi-synthetic products. Therefore the origins of ephedrine(natural, semi-synthetic or synthetic) could be discriminated by using carbon and nitrogen stable isotope ratios. we are sure tat this stable isotope ratio analysis can discriminate the origins of precursors of methamphetamine.

• Archives of Pharmacal Research
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• 제27권2호
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• pp.239-245
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• 2004

KR-31543, (2S,3R,4S)-6-amino-4-[N-(4-chlorophenyl)-N-(2 -methyl-2H-tetrazol-5-ylmethyl) amino]-3,4-dihydro-2-dimethoxymethyl-3-hydroxy-2-methyl-2H-1-benzopyran, is a new neuroprotective agent for preventing ischemia-reperfusion damage. This study was performed to identify the metabolic pathway of KR-31543 in human liver microsomes and to characterize cytochrome P450 (CYP) enzymes that are involved in the metabolism of KR-31543. Human liver microsomal incubation of KR-31543 in the presence of NADPH resulted in the formation of two metabolites, M1 and M2. M1 was identified as N-(4-chlorophenyl)-N-(2-methyl-2H-tetrazol-5-ylmethyl)amine on the basis of LC/MS/MS analysis with a synthesized authentic standard, and M2 was suggested to be hydroxy-KR-31543. Correlation analysis between the known CYP enzyme activities and the rates of the formation of M 1 and M2 in the 12 human liver microsomes have showed significant correlations with testosterone 6$\beta$-hydroxylase activity (a marker of CYP3A4). Ketoconazole, a selective inhibitor of CYP3A4, and anti-CYP3A4 monoclonal antibodies potently inhibited both N-hydrolysis and hydroxylation of KR-31543 in human liver microsomes. These results provide evidence that CYP3A4 is the major isozyme responsible for the metabolism of KR-31543 to M1 and M2.

• 대한예방한의학회지
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• 제23권2호
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• pp.43-51
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• 2019

Objectives : This study aimed to analyze price variance by year, region and company of raw herbal medicines to draw payment system for herbal medicine insurances in the National Health Insurance. Methods : To analyse price variance, we used 2015-2017 data of 'Quality test results of imported herbal medicines' provided by Korea Pharmaceutical Traders Association and 'Price data of 56 raw herbal medicines' that was surveyed by the Association of Korean Medicine. We analysed gap of highest price and lowest price those were compared with average price and coefficient of variation(CV) of prices by year, region and company of raw herbal medicines. Results : In analysing 3 years data, the highest price was 23.2% higher, and the lowest price was 19.1% lower than the average price. As of 2018, the average price of domestic produced herbal medicines was 1,8 times higher than that of imported herbal medicines. By companies, the highest price was 117.5% higher, and the lowest price was 57.3% lower than the average price. Conclusions : The price of herbal medicines varied by production year, region and company. This results suggest that comprehensive payment model needs to be considered in modeling the health insurance coverage for herbal medicine decoctions.