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.
Journal of the Korea Academia-Industrial cooperation Society
/
v.18
no.12
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pp.329-334
/
2017
In this study, a new granular type mouthwash with equivalent antibacterial activity to marketed liquid type mouthwash was developed using a material called magnesium aluminometasilicate (Neusilin). This material adsorbs the surface of granules to improve the flowability of granules due to the formation of a eutectic mixture of the main constituents, which have improved flow properties and rapid disintegration time and little residue in the oral cavity. The characteristics of the granules were improved when the amount of Neusilin was 10% or more according to measurements of the granule properties, such as flowability. In addition, a disintegration test in artificial saliva and a sensory test in the human oral cavity were carried out to confirm the improved disintegration characteristics and sensory test results. The antimicrobial test confirmed similar antibacterial activity to that of the liquid oral cleanser already sold in the market. The granular oral cleanser composition prepared in this study can be used for the development of pharmaceuticals containing different drugs with similar characteristics as eutectic mixtures at the same time, which is considered to be useful in the development of medicines in the pharmaceutical industry.
Depurination, the release of purine bases from nucleic acids by hydrolysis of the N-glycosidic bond, gives rise to alterations of the cell genome. Though cells have evolved mechanisms to repair these lesions, unrepaired apurinic sites have been shown to have two biological consequences: lethality and base substitution errors. 2-Bromopropane (2-BP) is used as an intermediate in the synthesis of pharmaceuticals, dyes, and other organics. In addition, 2-BP has been used as a replacement for chloroflurocarbons and 1,1,1-trichloroethane as a cleaning solvent in electronics industry. However, 2-BP was found to cause reproductive and hematopoietic disorders in local workers exposed to it. Owing to the toxicity of 2-BP, there has been a tendency to use 1-BP as an alternative cleaning solvent to 2-BP. However, 1-BP has also been reported to be neurotoxic in rats. Though $N^7$-guanine adduct of 2-BP has been reported previously, massive depurination of the nucleosides and calf thymus DNA was observed in this study. We incubated the nucleosides (ddG, dG, guanosine, ddA, dA and adenosine) with excess amount 2-BP at the physiological condition (pH 7.4, $37\;{^{\circ}C}$), which were analyzed by HPLC and LC-MS/MS. In addition, the time and dose response relationship of depurination in nucleosides induced by 2-bromopropane at the physiological condition was investigated. Similarly, incubation of calf-thymus DNA with the excess amount 2-BP at the physiological condition was also performed. In addition, the time and dose response relationship of depurination in calf-thymus DNA induced by 2-BP at the physiological condition was investigated. Those results suggest that the toxic effect of 2-BP could be both from the depurination of nucleosides and DNA adduct formation.
Lee, Bo Mi;Park, Sang-Jun;Shim, Da-Young;Rhee, Ha Eun;Lee, Jeong-Eun;Kim, Sang Hee;Cho, Hea Kyoung;Shin, Ju-Young
Korean Journal of Clinical Pharmacy
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v.31
no.1
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pp.53-60
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2021
Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. Methods: We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. Results: All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. Conclusion: All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission. Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.
According to an analysis of 560 foreign-invested companies investing in South Korea's manufacturing industry, the following three facts were found. First, the proportion of sales by manufacturing foreign-invested companies is divided into 68.5 percent of domestic sales and 31.5 percent of exports. From 68.5 percent of domestic sales, sales to Korean companies are 60.5 percent, including 37.1 percent for large companies and 23.4 percent for small and medium-sized companies, while only 8.0 percent for domestic consumers. Second, the investment sectors of manufacturing foreign-invested enterprises are 'machine and equipment manufacturing', 'chemical and chemical-chemical material manufacturing-excluding pharmaceuticals', 'electronic components, computers, video, sound and communication equipment manufacturing' and 'vehicle and trailer manufacturing'. It overlaps with electric·electronics, petro-chemicals and automobiles, which are Korea's main industries and areas of Korean global companies. Third, 31.5 percent of the sales of foreign-invested companies in the manufacturing sector are exported. Foreign-invested companies export their products to use them for their parents or affiliates or to the third countries. The analysis shows that foreign-invested companies invested in Korea for B2B transactions with Korean companies. The implications are that Korea can attract foreign investments by utilizing Korean companies' demand for intermediate goods. Foreign-invested companies can invest in Korea in order to use Korea, which has signed free trade agreements with the US, the EU and ASEAN, as an export platform.
Journal of Korea Society of Industrial Information Systems
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v.29
no.2
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pp.133-151
/
2024
The purpose of this study is to analyze the core values of Donghwa Pharmaceutical, which has been in the pharmaceutical industry in South Korea for 126 years, and examine the core competencies that have consistently enabled it to maintain a competitive advantage. When applying the VRIO Framework, various general pharmaceuticals, including Donghwa Pharmaceutical's 'Hwalmyeongsoo,' which has maintained the top position in the liquid digestive medicine market for 126 years, are identified as powerful resources (Value) that generate 'sustained competitive advantage.' The principles of ethical management based on the Donghwa spirit, the long-standing principles of trust and belief, and the entrepreneurial spirit possess rarity. Having won four Guinness World Records and holding numerous new drug patents, Donghwa Pharmaceutical has consistently secured the top position in the digestive medicine category of the Korean Industrial Brand Power for 19 consecutive years. The company has been designated as a 'Golden Brand,' and its products have high levels of awareness, making them highly difficult to imitate. Lastly, the organization is structured to efficiently utilize resources such as a transparent hierarchical system, fair personnel management, diverse training programs, and high employee welfare and salaries. This study systematically analyzes the core values of Donghwa Pharmaceutical from a managerial perspective and proposes directions for the company to evolve into a long-lasting enterprise. The research outcomes will provide valuable insights for formulating long-term management strategies.
Kim, Jung Hoan;Kho, Young Lim;Kim, Pan Gyi;Jeong, Jee Yeon;Lee, Eun Hee;Lee, Seung-Youl;Nam, Hye-Seon;Rhee, Gyu-Seek
Journal of Environmental Health Sciences
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v.38
no.6
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pp.561-567
/
2012
Objectives: Parabens are widely used as antimicrobial agents in pharmaceuticals and cosmetics as well as by the food industry. Parabens have been reported to show weak estrogenic activity and be related to health effects such as allergic reactions and skin and breast cancer. We evaluated an online solid phase extraction (SPE) method coupled with LC-MS/MS technique using free and conjugated parent parabens in human urine for assessing human exposure to parabens. Methods: We employed LC/MS/MS through online solid phase extraction and column-switching techniques and analyzed free and conjugated parabens as biomarkers of human exposure. Four major parabens, methyl-paraben (MP), ethyl-paraben (EP), propyl-paraben (PP) and butyl-paraben (BP), were analyzed. Method validation was performed by sensitivity, accuracy, precision and comparison of the results of online SPE with offline SPE. Results: The limits of detection (LOD) were in the range of 0.2-2 ng/mL, and actual limits of quantification (LOQ) were in the range of 0.7-6 ng/mL urine, depending upon the compound. Accuracy was in the range of 98.3-106.4%, and precision was in the range of 1.3-8.7% (CV) depending upon the compound. We found a good correlation between the results of analysis by online SPE method and that by off-line SPE method. Conclusions: The online SPE method showed proper LOD and validated accuracy, precision and good correlation with the offline method for analyzing parabens in urine.
Insects represent the largest class within the animal kingdom in terms of species number. Humans had been utilized insect in the broad area, including food, agriculture, industry, pharmaceuticals and so on. At present, insects are emerging as a leading group for identifying and extracting novel bioactive substances due to enormous number and a high nutritional value. Insects rely on a suite of systemic response to resist infection such as immune cells, hemocytes, activation of enzymes cascades, and antimicrobial peptide/protein. Among the substances, antimicrobial peptides (AMPs) are main components of potent antimircrobial innate defense system into the insect hemolymph. AMPs raise influential candidate as avenue to resolve the development of antibiotic-resistant microbial organism. Insect AMPs are classified into four main classes: cecropins, insect defensins, glycine/proline-rich peptides. Insect AMPs have been purified, over 150. In this review, AMPs derived from several insects were summarized including honey bee, dung beetle, butterfly and longicorn beetle. These peptides almost exhibited potent antimicrobial activities against human microbial pathogens without causing remarkable hemolysis to erythrocytes excluding melittin, and their mode of action(s) are based on disruption of the plasma membrane or fungal apoptosis. Therefore, study of insect AMPs is expected to be useful for designing novel therapeutic antimicrobial applications.
Seo, Jeong-Hyeon;Lee, Hong-Tae;Kim, Tae-Kyung;Cho, Young-Hoon;Oh, Taek-Keun;Park, HoSik
Membrane Journal
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v.32
no.5
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pp.348-356
/
2022
With the development of the bio industry, membrane chromatography with a high adsorption efficiency is emerging to replace the existing column chromatography used in the downstream processes of pharmaceuticals, food, etc. In this study, through the deacetylation reaction of two commercial cellulose acetate (CA) membranes with different pore sizes, the porous regenerated cellulose (RC) supports for membrane chromatography were obtained to attach the anion exchange ligands. The adsorptive membranes for anion exchange were prepared by attaching an anion exchange ligand ([3-(methacryloylamino) propyl] trimethylammonium chloride) containing quaternary ammonium groups on the RC supports by grafting and UV polymerization. The protein adsorption capacities of the prepared membranes were obtained through both the static binding capacity (SBC) and the dynamic adsorption capacity (DBC) measurement. As a result, the membrane chromatography with the smaller the pore size, the larger the surface area showed the highest protein adsorption capacity. Membrane chromatography which was prepared by using deacetylated commercial CA support with MAPTAC ligand (i.e., RC 0.8 + MAPTAC: 43.69 mg/ml, RC 3.0 + MAPTAC: 36.33 mg/ml) showed a higher adsorption capacity compared to commercial membrane chromatography (28.38 mg/ml).
Sesame(Sesamum indicum L.) is probably the most ancient oilseed crop known in the world. The seed of sesame is used in a variety of ways as food. The whole seed may be eaten raw, either roasted or parched, or fed to birds and stock. Sesame oil is used as a salad or cooking oil, in shortening, margarine and in the manufacture of soap. Minor uses are as a fixative in the perfume industry and formerly as a carrier for fatsoluble substances in pharmaceuticals such as penicillin. One of the minor constituents of sesame oil, sesamin, is used for its synergistic effect in pyrethrin insecticides, in addition of a small quantity of this substance markedly increases the effectiveness of fly sprays. The meal remaining after oil extraction can be used as and animal feed-stuff or as manure. In general sesame meal is considered to be equal to cottonseed or soybean meal as a protein supplement for livestock and poultry. It is especially high in certain amino-acids such as methionine, which is low in soybean meal, and thus can be combined with it or similar meal to form a more balanced ration. An attempt to summarize the literature review on quality improvement of sesame was made to discuss the accomplishments of the past and perspectives in the future. The reviews on quality improvement of sesame were mainly discussed in connection with the cultural practices and genetic informations in current status. The emphasis focussed on environmental variation of quality in cultural practices, such as harvest time, variety by location, climatic condition, fertilizer application, and growth regulator treatment. On the genetic variation of quality, it was discussed on variety background, mutation breeding, correlations, and inheritance of quality related characteristics. It also was discussed on relationship between quality and plant traits, storage condition or period, and seed coat color. Moreover, current research status were reviewed on some minor elements such as sesamin, oxalic acid, and trypsin inhibitor. As a results of the review, the lack of an effort to quality improvement in each utilization area was indicated as a problem area. More active efforts for the improvement of quality were also insufficient to incorporate the available genes for quality in breeding method or collection and analysis of breeding materials. Therefore, researches in the future would be recommended to emphasize on these problem areas.
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