• Korean System Dynamics Review
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• v.6 no.2
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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.

• Proceedings of the Korean Society of Toxicology Conference
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• 2002.11b
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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)

• Journal of Korea Technology Innovation Society
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• v.20 no.2
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• pp.313-333
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• 2017

As science and technology advanced, specialized and massive, development through mutual cooperation or research based on patent licensing such as material transfer contract, technology transfer contract etc are actively taking place to minimize or separate the cost and risk of R&D. In R&D, such mutual work can enjoy the merit of division of labor by effectively allocating resources and manpower to accomplish its goal. Inevitably, however, there are also many possibilities of disputes regarding the ownership and use of intellectual property rights resulting from such mutual/post-studies, or inventions upgraded by using prior patents. The case reviewed by this paper is noticeable regarding the recent trend of upgraded inventions. In the case, a pharmaceutical company conducted tests/assessments on the complete technology of patent owned by a university on the premise of transferring the technology, and then terminated the technology transfer contract due to reasons of toxicity. The university then filed a damage claim suit against the company for infringing the contract. This is a dispute case betw een a university which developed a potential ingredient for new medicine and a pharmaceutical company which agreed to transfer and receive the technological later on. Regarding the upgraded inventions of source patents, this case has many implications on the protection of prior patents, research contract, and research security to protect the accomplishment of research. This paper reviews the subject ruling and the protection of upgraded patents and source technologies. As critical notes, the paper also summarizes the major issues of case ruling to observe the standard of ruling patent infringement related to the extortion of upgraded patents. Then, through the ruling of the case above, the paper suggests implications and future strategies.

• Archives of Pharmacal Research
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• v.25 no.5
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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.

• YAKHAK HOEJI
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• v.55 no.5
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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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• v.31 no.2
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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.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.19 no.10
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• pp.490-497
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• 2018

This study is to identify factors influencing therapeutic diversification strategy for Korean pharmaceutical companies. So, it purposes to find deciding factors for companies to adopt strategy for diversification or specialization. In this paper, we set six factors that are expected to influence diversification. The factors are asset scale, sales, profitability, and growth potential. Also, we included number of employees and SG&A cost ratio as factors that reflect business characteristics. We analyzed the impacts of each factor on diversification and found a relationship amongst each other. In this paper, regression analysis is applied with forward selection method, considering that it takes 5 years for companies to decide on diversification strategy. As a result, asset scale, the number of employees and profitability have significantly influenced decisions of diversification at t-1 time, and growth potential was significantly influenced at t-2 time. Korean pharmaceutical companies generally tend to go with specialization model if they have larger asset scale, higher profitability and growth potential. However, they have tendency to decide on diversification strategy, if they have large number of employees. Overall, the result of this study is expected to provide useful information for Korean pharmaceutical companies to set the suitable strategy for their situation to become a competitive company in global pharmaceutical market.

• YAKHAK HOEJI
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• v.53 no.5
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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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• v.27 no.2
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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.

• Journal of Society of Preventive Korean Medicine
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• v.23 no.2
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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.