• Korean Journal of Clinical Pharmacy
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• v.33 no.2
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• pp.86-96
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• 2023

Background: Using KIDS-KAERS database (KIDS-KD) from 2016 to 2020, the aim is to investigate signals of adverse events of alpha-adrenoceptor antagonists and to present adverse events that are not included in the precautions for use when marketing approval. Methods: This study was conducted by disproportionality analysis. Data mining analysis was performed to detect signals of alpha-adrenoceptor antagonists, such as terazosin, doxazosin, alfuzosin, silodosin, and tamsulosin. The signal was defined by three criteria as proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). Detected signals were compared with product labeling and the European Medicines Agency-Important Medical Events list. Results: Out of the total number of 408,077 reports for adverse events, 6,750 cases were reported as adverse events of alpha-adrenoceptor antagonists. Dizziness, mouth dryness, hypotension postural, and oedema peripheral are identified as common adverse events of five alpha-adrenoceptor antagonists and are typically listed on drug labels. However, new signals were detected for pneumonia, chronic obstructive airway disease, eye diseases such as glaucoma and cataracts, fracture, and ileus of tamsulosin that were not previously listed on the drug labels in Korea. Conclusions: This study identified signals related to adverse drug reactions of alpha-adrenoceptor antagonists and presented serious adverse events, suggesting new adverse reactions to be aware of when using alpha-adrenoceptor antagonists.

• Knowledge Management Research
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• v.14 no.1
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• pp.39-55
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• 2013

As the importance of intellectual property rights for the 21st century challenge became prominent, many companies have been trying to secure many rights competitively. In particular, application numbers of patent that represents technology has been increased continuously. Korean companies were not exception; mainly in large companies, there have been continued the efforts to grow the number of patent applications in quantitative volume. But the issues that how viable patents the companies have, how effectively the companies manage, and how economically usable the patents are, are totally different from quantitative management level. As such, the issue is connected to how to assess the patent management level of companies. On the other side of quantitative growth of patent that companies hold, there are some problems such as the difficulties to determine if the patents hold substantial values, and the difficulties to determine whether the patent are managed effectively. In addition, as the numbers of patent application and registration of companies are increased, the cost for patent holding and managing increase. It is required to pay continuous attention to the cost of patent management because patent registration fee has a property that increases rapidly with time and burden for patentee become heavier. As a result of analysis and interpretation, we confirmed that quantitative management, particularly the number of patent applicant does not make positive impact on how to use patent after application. Rather, it is observed that the economical usage is influenced positively by the efforts of patent applicants such as considering for the time of patent examination, paying attention to receive patent registration decision. Therefore, this study shows that efforts patent applicants provide in management level after application time are important to maintain the value of patents.

• Proceedings of the Plant Resources Society of Korea Conference
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• 2001.11a
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• pp.9-14
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• 2001

Today information is important for man and total fields. Science field is not exception. Currently information age things of information is only useful for man and total industry. So bioinformation is necessary of biodiversity in broadly wide and detailed information. Among information, bioinformation of biodiversity is important and utilization of living things. Among them, the mushroom(higher fungi) are an Important part in ecosystem as a decomposer responsible for recycling materials . Many living things today, however, have endangered by environmental pollution and ecological destruction. The higher fungi also are not exception. Mushroom has been used for food sources, pharmacy and forests resources from ancient times. Among biodiversity, database of mushroom is very necessary for university, institute and industry. This DB contains four items of native mushroom(higher fungi) from Korea. first item contain species, genus, family, order class, ad division according to the classification. Second item contain pharmaceutical purpose, food source, culture, toxic, anti-cancer of the application. Third item contain symbiosis, rotten trees of the ecological resources. Fourth item contain geographical distribution and illustrated literature. Information system is also available using KRISTAL II for searches on the WEB in URL http://ruby. kisti. re. kr/～mushroom

• Journal of Technology Innovation
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• v.20 no.2
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• pp.135-159
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• 2012

To the analysis and discussion whether to conceptualization between the basis and LCM(Life cycle management) of patentability decisions and evergreening through research on patent application strategies and litigation cases. The Stakeholders have said that the LCM and evergreening strategies are an innovative effort to develop new pharmaceuticals, while others say that it is an effort to block generic pharmaceuticals from entering the market and permanently dominate the market by generic pharmaceuticals manufacturers or health economic perspectives. To achieve the goal of research, to discuss for conceptualization LCM and Evergreening strategies through patent application strategies for 14 pharmaceuticals for APIs and case studies for litigations. As a results, the LCM is getting patent rights for the results of research at the initial R&D stage and as such this shall be regarded as part of an effort for technology innovation. However, Evergreening is granting patent rights for the results by making high permission barrier to prevent the market entry of generic pharmaceuticals in the late development period during the pharmaceuticals development process or after their launch. This may lead to the problem of getting weak in health economic aspects and consumer welfare aspects by lowering the market accessibility of cheap generic pharmaceuticals.

• Journal of Pharmaceutical Investigation
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• v.40 no.1
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• pp.1-7
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• 2010

K-$BEtest^{(R)}$ is a well known program for bioequivalence test using a $2{\times}2$ design. Lee et al.(1998) and Park et al.(1999) suggested a $3{\times}3$ and $3{\times}2$ design, and also discussed their benefits. We developed a computer program, called BioEquiv, which can analyze some complex experimental designs such as, $3{\times}3$ design and $3{\times}2$ design including a standard $2{\times}2$ design. This program is a user-friendly one and overcomes the disadvantages of K-$BEtest^{(R)}$. The detailed statistical formula and structure of BioEquiv are presented with some examples. The comparison between K-$BEtest^{(R)}$ and BioEquiv are given with actual data analysis. BioEquiv is able to present a table of ANOVA test over some complex experimental designs. Moreover K-$BEtest^{(R)}$ and BioEquiv draw the same result when data consists of $2{\times}2$ design.

• Safety and Health at Work
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• v.2 no.4
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• pp.375-379
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• 2011

Control Banding (CB) strategies to prevent work-related illness and injury for 2.5 billion workers without access to health and safety professionals has grown exponentially this last decade. CB originates from the pharmaceutical industry to control active pharmaceutical ingredients without a complete toxicological basis and therefore no occupational exposure limits. CB applications have broadened into chemicals in general - including new emerging risks like nanomaterials and recently into ergonomics and injury prevention. CB is an action-oriented qualitative risk assessment strategy offering solutions and control measures to users through "toolkits". Chemical CB toolkits are user-friendly approaches used to achieve workplace controls in the absence of firm toxicological and quantitative exposure information. The model (technical) validation of these toolkits is well described, however firm operational analyses (implementation aspects) are lacking. Consequentially, it is often not known if toolkit use leads to successful interventions at individual workplaces. This might lead to virtual safe workplaces without knowing if workers are truly protected. Upcoming international strategies from the World Health Organization Collaborating Centers request assistance in developing and evaluating action-oriented procedures for workplace risk assessment and control. It is expected that to fulfill this strategy's goals, CB approaches will continue its important growth in protecting workers.

• Journal of Society of Preventive Korean Medicine
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• v.5 no.1
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• pp.57-75
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• 2001

This study was conducted to improve the current regulation guidelines for developing traditional Korean medicines with effectiveness and productivity, in order to cope with the upcoming ICH on specifications on oriental herbal drugs. Also, major purposes of this study are to motivate R&D and to pioneer foreign markets for domestic herbal drug companies. First, after examining concepts of traditional Korean medicines and comparing the numbers and differentiation of herbal drugs registered on Pharmacopeia among Korea, China, and Japan, the current new drug development requirements for traditional Korean medicines were reviewed in detail, followed by comparison of foreign regulation systems including USA, EU, China, and Japan. Second, empirical cases on failure of development for new traditional Korean medicines under the current regulation system in the domestic companies including Dong-A, Kwangdong, and Samchondang, were collected and analyzed. As a result, hanbangsaengyak, the new category for traditional Korean medicines was newly developed on the basis of scientification of data between saengyak and hanyak, from the perspectives of harmonization between oriental medicine and western medicine and of balance between food and drug, in terms of industrialization, publicity, modernization, and effectiveness of administration. In addition, the new regulation requirements for the new hanbangsaengyak preparations were discussed by establishing principles of reinforcing preclinical test and of simplifying clinical trials in Korea. Finally, the further researches to articulate the complete specifications for pre-clinical and clinical requirements for traditional Korean medicines were strongly suggested.

• Plant Resources
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• v.4 no.3
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• pp.153-156
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• 2001

Today information is important for man and total fields. Science field is not exception. Currently information age things of information is only useful for man and total industry. So bioinformation is necessary of biodiversity in broadly wide and detailed information. Among information, bioinformation of biodiversity is important and utilization of living things. Among them, the mushroom(higher fungi) are an important part in ecosystem as a decomposer responsible for recycling materials. Many living things today, however, have endangered by environmental pollution and ecological destruction. The higher fungi also are not exception. Mushroom has been used for food sources, pharmacy and forests resources from ancient times. Among biodiversity, database of mushroom is very necessary for university, institute and industry. This DB contains four items of native mushroom(higher fungi) from Korea. first item contain species, genus, family, order class, ad division according to the classification. Second item contain pharmaceutical purpose, food source, culture, toxic, anti-cancer of the application. Third item contain symbiosis, rotten trees of the ecological resources. Fourth item contain geographical distribution and illustrated literature. Information system is also available using KRISTAL II for searches on the WEB in URL http://ruby. kisti. re. kr/∼mushroom.

• Journal of Radiation Industry
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• v.8 no.2
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• pp.77-81
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• 2014

Hyaluronic acid is a disaccharide polymer that consists of glucuronic acid and N-acetylglucosamine, and is a glycosaminoglycan. It is widely distributed in animal connective tissue, coexisting with chondroitin sulfate. It forms viscous secretions or gel by bonding to protein in the body, and thus maintains and lubricates tissue structures. In addition, its antibiotic properties are applied to cosmetics and pharmaceuticals. Therefore, it has recently been an object of great interest at cosmetic and pharmaceutical companies. $^{125}I$ has a longer half-life (59.4 days) than many other radioisotopes, and is therefore useful to long-term studies. In this study, a facile and efficient procedure for the synthesis of $^{125}I$-labeled hyaluronic acid has been designed for in vivo imaging and pharmacokinetic studies of hyaluronic acid, which are required for the development of new drugs.

• The Korean Journal of Health Service Management
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• v.13 no.4
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• pp.215-228
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• 2019

Objectives: The purpose of this study is to figure out that Facilitation education can affect significant improvement in sales staff's understanding of precise pharmacokinetics, benefits, safety, and side effects, etc. and eventually lead to increase in call after taking courses. Methods: Data utilized in this study was collected from 413 sales staffs who completed Facilitation course for 5 months. This study used statistical methodologies, paired t-test, exploratory factor analysis, and logistic regression model in order to identify change in Call and after Facilitation courses. Results: The result shows that there are statistically significant increases in CALL quality after Facilitation courses based on the result of pared t-test. Moreover, Facilitation education is more effective in average time of one-time detail than average number of visits per day and average number of doctors per day from the result of logistic regression. Conclusions: In order for MR in pharmaceutical company to improve CALL quality, the education for precise pharmacokinetics, benefits, safety, and side effects is necessary. In addition, various professional training required for detail, including disease education, Selling Skills education, and literacy education are essential. Therefore, Facilitation education would be desirable choice in terms of pharmaceutical marketing strategy.