Objectives : This article reviews a solution preventing the illegal distribution of herbal medicine in common use for food and medicine and risks on public health by conducting safety management of food and medicine. Also, this article would like to contribute to improvement of public health treating diseases in compliance with accurate diagnosis and prescription of Oriental Medicine Doctor("OMD")'s. Methods : An approach in this research can be categorized into two : first, to examine the current administrative situation and problems of herbal medicine in common use for food and medicine based on policy documents of Ministry of Health and Welfare and Korea Food and Drug Adminstration("KFDA") and academic articles of the herbal medicine;second, to find reasonable administrative solutions to solve the problems. Solutions : A solution is to strengthen the management level of herbal medicine in common use for food and medicine by selecting 117 items as target items requiring concentrated management. In case herbal medicine is imported for food, KFDA strengthens the quality management level of herbal medicine by making use of inspection frequency at random, collecting and verifying herbal medicine on the market. However, KFDA decides to maintain current different quality specification system of food and medicine reflecting a civil complaint that quality specification of food and medicine should separately managed according to the purpose of use. Herbal medicine as medicine that is functioned as treating diseases and alleviating symptoms, unlike herbal medicine for food, can cure all kinds of diseases by recovering inner balance of human body, making use of other properties of herbal medicine. Medicine has its own properties. If a doctor uses properties of medicine appropriately, he cures diseases. If a doctor uses herbal medicine inappropriately. he may damage human body. Thus, whether side effects of medicine depend on a doctor who uses herbal medicine. Conclusions : All herbal medicine will be supplied into the market after strict safety control of manufacturers of herbal medicine according to the revised Pharmaceutical Affairs Act, beginning in April, 2012. Thus, people can take safer and more reliable herbal medicine through strengthening safety management of herbal medicine and improving quality and transparency in the distribution system. Herbal medicine should appropriately be prescribed by licensed OMD because herbal medicine is used to treat diseases and alleviate symptoms, unlike herbal medicine for food.
With regard to the development of new drugs, what is most important for a Korean Biotech, where no global sales network has been established, is decision-making related to out-licensing of new drugs. The probability of success for each clinical phase is different, and the licensing amount and its royalty vary depending on which clinical phase the licensing contract is made. Due to the nature of such a licensing contract and Biotech's weak financial status, it is a very important decision-making issue for a Biotech to determine when to license out to a Big Pharma. This study defined a model called 'optimal timing for out-licensing of new drugs' and the results were derived from the decision tree analysis. As a case study, we applied to a Biotech in Korea, which is conducting FDA global clinical trials for a first-in-class new drug. Assuming that the market size and expected market penetration rate of the target disease are known, it has been shown that out-licensing after phase 1 or phase 2 of clinical trials is a best alternative that maximizes Biotech's profits. This study can provide a conceptual framework for the use of management science methodologies in pharmaceutical fields, thus laying the foundation for knowledge and research on out-licensing of new drugs.
We forecast the performance of the Korean biotechnology industry by adopting similar development paths taken by the U.S. biotechnology and Korean ICT industries. Our long-term forecasting techniques predict that Korean BT market size will increase from 3.7 billion to 10.8 billion U.S. dollars by year 2030. The pharmaceutical industry, one of major bio-subindustries, is expected to dominate Korean BT market in the long-run. Also, the relative portion of the exports in the Korean BT industry will be larger and thus the export-oriented government policy is required for the long-run growth of the Korean BT industry. Since the Korean ICT industry has already slowed down in the development, Korean BT industry is likely to catch up with ICT industry in the near future.
New product innovation is a process of embodying new knowledge in a product and technology licensing is getting popular as a means to innovations and introduction of new product to the market in today's competitive global market environment. Incumbents often rely on technology licensing to access new product opportunities created by other firms. Prior research has examined various aspects of technology licensing agreements such as specific contract terms of licensing agreements, e.g., distribution of control rights, exclusivity of licensing agreements, cross-licensing, and the scope of licensing agreements. This study aims to provide answers to an important, but under-researched question: why do some incumbents initiate more licensing agreement for exploratory learning while others do it for exploitative learning along the innovation process? We attempt to extend our knowledge of licensing agreements from an organizational learning perspective. Technology licensing as a specific form of interfirm linkages can be initiated with different learning objectives along the process of new product innovation. The exploratory stages of the innovation process such as discovery or research stages involve extensive searches to create new knowledge or capabilities, whereas the exploitative stages of the innovation process such as application or test stages near the commercialization are more focused on developing specific applications or improving their efficiency or reliability. Thus, different stages of the innovation process generate different types of learning and the resulting technological resources. We examine when incumbents as licensees initiate more licensing agreements for exploratory learning objectives and when more for exploitative learning objectives, focusing on two factors that may influence a firm's formation of exploratory and exploitative licensing agreements: 1) its past radical and incremental innovation experience and 2) its internal investments in R&D and marketing. We develop and test our hypotheses regarding the relationship between a firm's radical and incremental new product experience, R&D investment intensity and marketing investment intensity, and the likelihood of engaging in exploratory and exploitive licensing agreements. Using data collected from various secondary sources (Recap database, Compustat database, and FDA website), we analyzed technology licensing agreements initiated in the biotechnology and pharmaceutical industries from 1988 to 2011. The results of this study show that incumbents initiate exploratory rather than exploitative licensing agreements when they have more radical innovation experience and when they invest in R&D activities more intensively; in contrast, they initiate exploitative rather than exploratory licensing agreements when they have more incremental innovation experience and when they invest in marketing activities more intensively. The findings of this study contribute to the licensing and interfirm cooperation studies. First, this study lays a foundation to understand the organizational learning aspect of technology licensing agreements. Second, this study sheds lights on how a firm's internal investments in R&D and marketing are linked to its tendency to initiate licensing agreements along the innovation process. Finally, the findings of this study provide important insight to managers regarding which technologies to gain via licensing agreements. This study suggests that firms need to consider their internal investments in R&D and marketing as well as their past innovation experiences when they initiate licensing agreements along the process of new product innovation.
This paper conducts a comparative analysis of the KORUS FTA and the TPP Agreement to assess the current state of affairs in international trade rules for the pharmaceutical industry. Intellectual property rights as well as public health related regulations have evolved to strengthen the position of innovator drug companies. In particular, the TPP Agreement which adopted data exclusivity for biologics for the first time, will set the standard for the future. Apart from this however, the TPP Agreement has not gone further than the KORUS FTA and in some respects, even contains greater policy flexibilities and provisions for market access than the KORUS FTA. Korea should take advantage of such differences when and if she must engage in negotiations to join the TPP Agreement or a renegotiation of the KORUS FTA.
A major portion of drugs used in Ayurvedic system of medicine which has been practiced since the early human civilization in Indian subcontinent were of plant origin. It should be noted that 70% of the population in this region depends on Ayurveda for their medical treatment and 60% of the drug resources are obtained from the Himalayan region. Therefore, Nepal becomes a potential source of plant drug resource since it occupies a major portion of the Himalaya. In the present paper, in general a current status of medicinal plant resources of Himalayan region especially Nepal will be discussed. In addition to this, a typical example of antidiabetic activity of Shilajit will be taken for the discussion. Shilajit is one of the crucial elements in several formulations including those of Rasayana, a therapy in Ayurveda, which has been practiced in the prevention of ageing and mental disorder. Although, Shilajit is widely used for the treatment of diabetes, no satisfactory scientific reports are available up to now. The crude Shilajit in the market is a dark brown or black rock-like substance collected from the Himalayan region with a strong smell of cow's stale urine. In our studies, Shilajit (collected in the central Himalayan region) prevented the diabetes in nonobese diabetic (NOD) mice model. Shilajit also prevented the diabetes in the rats against the action of multiple low-dose (10 mg/kg, i.v., 5 times) of streptozotocin. On the other hand, Shilajit did not show antioxidative activity. The preventive action of Shilajit on diabetes is mainly focused on the Thl and Th2 cell activities, since Th2 cells activity was found to be significantly upregulated. Shilajit, however, showed a mild action in controlling the blood sugar level in young, old, and mild diabetic rats, but not in the severe diabetic rats. It also stimulated the nitric oxide production in macrophages. Based on these evidences, the antidiabetic activities of Shilajit appear to be immunomodulative probably by protecting or strengthening insulin-producing b-cells in the pancreas. Further systematic research on constituents of Shilajit and its quality evaluation is necessary to enable the use of natural medicines in the treatment of diabetes.
Complex formations of practically insoluble antelmintic drugs such as mebendazole (MBZ), albendazole (ABZ) and flubendazole (FBZ) with dimethyl-$\beta$-cyclodextrin (DM-$\beta$-CyD) and 2-hydroxypropyl-$\beta$-cyclodextrin (HP-$\beta$-CyD) together with $\alpha$-, $\beta$- and $\gamma$-cyclodextrins(CyDs) in duffered solutions were investigated by solubility method. $A_{L}$ type phase solubility diagrams were obtained in all cases except for the complexation (B$_{s}$, type) of FBZ with $\gamma$-CyD. The highest stability constants were obtained with DM-$\beta$-CyD, followed by $\alpha$-CyD > $\beta$-CyD > HP-$\beta$-CyD > $\gamma$-CyD for ABZ, and HP-$\beta$-CyD > $\gamma$-CyD > $\beta$-CyD > $\alpha$-CyD for FBZ at pH 1.2. On the other hand, solid dispersion systems of ABZ and FBZ with $\beta$- and DM-$\beta$-CyDs were prepared by solvent evaporation method and evaluated by dissolution, differential thermal analysis and powder x-ray diffractometry. The dissolution rates of ABZ- and FBZ-DM-$\beta$-CyD solid dispersions were much faster than those of drugs alone, corresponding physical mixtures and tablets on market both at pH 1.2 and 6.8. Although dissolution rates of all samples at pH 6.8 were by far lower than those obtained at pH 1.2, as explained by pH-solubility profiles for ABZ and FBZ, the dissolution rates at pH 6.8 of ABZ from $\beta$- and DM-$\beta$-CyD solid dispersions exceeded the respective equilibrium solubility (23.9 $\mu\textrm{g}$/ml). Fast dissolution of ABZ from solid dispersions with CyDs was attributed to the reduction of drug crystallinity and particle size which was supported by DTA and powder x-ray diffractometry. Consequently these results suggest that solid dispersion systems with CyDs may provide useful means to markedly enhance the solubility and dissolution of benzimidazole antelmintic drugs.
This paper seeks to analyze how the welfare state has developed both in the Kim Young Sam government and in the Kim Dae Jung government. Among other things, the two governments share some similarities: compared to the previous authoritarian governments, both of them enjoyed a high level of democratic legitimacy; the two were under pressure to win the elections to acquire and remain in power; and finally, the two tried to strengthen welfare system. But there exist more critical differences. The Kim Dae Jung government was a minority government, while the Kim Young Sam government was a majority one. Compared to the latter one, the former came to power in an extremely bad economic condition. Fortunately, however, the Kim Dae Jung government was able to enjoy a relatively high level of state autonomy resulting from an exceptional situation of foreign currency crisis. In addition, it was more reformist in policy orientation and had a more open cooperative network with civil society. All these differences added up to produce remarkable differences with regard to the improvement in welfare development. Especially, it is noted that the Kim Dae Jung government was very successful in several respects: provision of national minimum, integration of national medical insurance, development of productive welfare system, and final1y increase in welfare spending. Recently, criticisms from the opposition party, the press, and middle and upper class people mount against the Kim Dae Jung government which has made significant mistakes in instituting the separation of medical and pharmaceutical businesses. However, the important improvements in welfare institutions and programs by the Kim Dae Jung government need to be maintained to deal with all the negative effects of a naked market economy. They must also be sustained to keep alive democracy that Korean people have fought for nearly half a century.
Background: The Ministry of Public Health (MOPH) in Lebanon provides cancer drugs free of charge for uninsured patients who account for more than half the total case-load. Other categories of cancer care are subsidized under more stringent eligibility criteria. MOPH's large database offers an excellent opportunity to analyze the cost of cancer treatment in Lebanon. Materials and Methods: Using utilization and spending data accumulated at MOPH during 2008-2013, the cost to the public budget of cancer drugs was assessed per case and per drug type. Results: The average annual cost of cancer drugs was 6,475$ per patient. Total cancer drug costs were highest for breast cancer, followed by chronic myeloid leukemia (CML), colorectal cancer, lung cancer, and Non-Hodgkin's lymphoma (NHL), which together represented 74% of total MOPH cancer drug expenditure. The annual average cancer drug cost per case was highest for CML ($31,037), followed by NHL ($11,566). Trastuzumab represented 26% and Imatinib 15% of total MOPH cancer drug expenditure over six years. Conclusions: Sustained increase in cancer drug cost threatens the sustainability of MOPH coverage, so crucial for socially vulnerable citizens. To enhance the bargaining position with pharmaceutical firms for drug cost containment in a small market like Lebanon, drug price comparisons with neighboring countries which have already obtained lower prices may succeed in lowering drug costs.
The purpose of the study is to present an analysis of the expatriate leasing market for highly-paid professionals residing in Seoul. The effects of physical and locational attributes, range of amenities along with expat's national and industrial attributes on housing rents are being empirically evaluated based on transactions. Using lease transaction data for the period of 1994 through 2013, the results show that physical and locational attributes which have been proved to affect conventional housing value are also confirmed to affect leasing housing rent for expatriate. Also this study finds the following results. First, housing rent is found to be influenced by foreign residents' occupation. Therefore banking, petrochemical, insurer and pharmaceutical company affect positively on housing rent while mechanic firms influenced negatively to rent. Second, housing rent is found to be affected by foreign residents' nationalities. The results indicate USA and the United Kingdom have a positive effect while French has a negative effect on rent.
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