• 의료법학
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• 제10권1호
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• pp.213-260
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• 2009

While the medical supplies have positive functions such as extending lifespan, recovering health, and preventing diseases, they also cause unexpected tragic consequences due to their side effects, and the magnitude of such damage inevitably increases due to the mechanism of mass production, mass distribution, and mass consumption of those medical supplies. Therefore, needless to say, the optimal way to prevent or reduce such damage is rather through medical supply manufacturers' producing non-defective products, or through the government's controlling production and sales of medical supplies with more aggressive exercise of regulatory authority on medical supply manufacturers, than through a remedy by a legal relief after using medical supplies. In this case, although the victim died due to the defect of the cold medicine, 'CONTAC 600', the drug company's responsibility to cover damages was not recognized because a defect could not be found in the then-manufacturing process. Thus, while pharmaceutical companies are gaining economic profits by producing and selling a medical supplies, if they do not take any remedy measures for the victims of their products' side effects, the victims have to use medical supplies under their own responsibility of taking a risk, and they have to accept the full damage of the potential consequence. Therefore, to remove such absurdity and contradiction, and to practically remedy the victim of medical supplies' side effects, the pharmaceutical side effects remedy project pending in the the Drugs, Cosmetics and Medical Instruments Lawneeds to be actively implemented.

• 약학회지
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• 제56권5호
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• pp.288-292
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• 2012

The aim of the paper is to ameliorate old research methods of Korean Pharmaceutical Codex to adjust the newest scientistic level which is necessary to maintain quality of medical supplies effectively. After reviewing result of Establishment of Dissolution Specifications for Generic Drugs in Korea Pharmaceutical Codex Monograph, there are two items chosen for the methods - Establishment of Dissolution Specifications for Generic Drugs in Korea Pharmaceutical Codex Monograph which KFDA researched in 2010, arranged new measuring standard by having an experiment to set measuring method after obtaining each item. According to the result, The experiment includes a measuring method of two items; Nafronyl Oxalate Capsules, and Ticlopidine Hydrochloride Tablets. The research is ameliorated by research methods through several experiments such as High Performance Liquid Chromatography validation, preparing items, implement of trial-experiment and authentic experiment, and experiment on measuring method of regulations of Korea Pharmaceutical Codex. The experiments are taken opinions of experts in KFDA into consideration and wrote out a report of the new measuring method on each last item. The report is combined as each two experiment sections of analyzing method to maintain the quality on the basis of the research in 2010 on setting of dissolution specifications for oral solid dosage forms. The result of measuring method of medical supplies through modernizing trial method of oral solid dosage forms is available to be accurate. In conclusion, this study could contribute to promotion of public health by organizing a basis for safe and high quality of medical supplies in domestic market.

• Advances in nano research
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• 제10권4호
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• pp.397-414
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• 2021

The steady growth in population has led to an enhanced water demand and immense pressure on water resources. Pharmaceutical residues (PRs) are unused or non-assimilated medicines found in water supplies that originate from the human and animal consumption of antibiotics, antipyretics, analgesics etc. These have been detected recently in sewage effluents, surface water, ground water and even in drinking water. Due to their toxicity and potential hazard to the environment, humans and aquatic life, PRs are now categorized as the emerging contaminants (ECs). India figures in the top five manufacturers of medicines in the world and every third pill consumed in the world is produced in India. Present day conventional wastewater treatment methods are ineffective and don't eliminate them completely. The use of nanotechnology via advanced oxidation processes (AOP) is one of the most effective methods for the removal of these PRs. Present study is aimed at reviewing the presence of various PRs in water supplies and also to describe the process of AOP to overcome their threat. This study is also very important in view of World Health Organization report confirming more than 30 million cases of COVID-19 worldwide. This will lead to an alleviated use of antibiotics, antipyretics etc. and their subsequent occurrence in water bodies. Need of the hour is to devise a proper treatment strategy and a decision thereof by the policymakers to overcome the possible threat to the environment and health of humans and aquatic life.

• 대한수의학회지
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• 제57권2호
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• pp.71-78
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• 2017

Well-established standards and specifications for medical devices not only provide clarity and consistency in licensing processes but also secure device safety and effectiveness. This study reviewed regulatory standards and specifications for veterinary medical devices in Korea based on data obtained through analyses of those medical devices. General standards for electromechanical, electromagnetic, and biological safety and individual standards for 76 electric and 70 general medical device products have been established by the Korean Ministry of Food and Drug Safety. However, the first standards and specifications for veterinary medical devices were established in March 2000 for two products (disposable needle and syringe). Similar to the large number of standards for medical devices, there have been general standards for safety and individual standards for 72 veterinary medical devices (27 electric medical devices, 12 non-electric medical devices, 10 medical supplies, and 23 other types) established since 2014. These new standards considered, among other aspects, the devices' applications, usage characteristics, and industrial environment. To date, the establishment of standards and specifications for veterinary medical devices remains limited. This study suggests that improvements should be made to the regulation of general and individual standards associated with various veterinary medical instruments, supplies, and in vitro diagnostic medical reagents.

• 유통과학연구
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• 제12권5호
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• pp.33-40
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• 2014

Purpose - This paper aims to review cold chain management, especially in the pharmaceutical industry, to explore the cold chain process of delivering temperature-sensitive pharmaceutical products, and to identify areas for further development. Research design, data, and methodology - The paper, based on literature review and corporate analysis, reviews the development and status of the cold supply chain system, including its important role in the pharmaceutical industry. Results - Logistics in this field requires more stages than are typically needed. Due to the unique characteristics of the market, few companies can provide the services; currently, only few global companies with large networks and high technologies can afford to do so. Expanding pharmaceutical markets to meet global demand will require cold chain development, especially in "pharmerging" markets. Conclusions - Cold chain is a highly sensitive market in terms of products being carried within the chain that itself is a complex system. However, at the same time, it is a niche market with new opportunities. Hence, a sound cold chain infrastructure is needed to satisfy companies, governments, and customers for both commercial and public reasons.

• 한국임상수의학회지
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• 제36권1호
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• pp.1-6
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• 2019

This study reviewed the trends and prospect of the market for veterinary medical devices in Korea. The registration of veterinary medical devices has sharply increased since 2013, and a total of 2,133 products from 348 companies were registered by 2018. Of these products, the proportion of the instrument, in vitro diagnostic (IVD) reagents, medical only used for animal and supplies were 51.6%, 35.7%, 7.6% and 5.1%, respectively. The sales amount of veterinary medical devices is approximately 95.8 billion won in 2017. The sales of domestic consumption and imports were 53.9 and 41.9 billion won, respectively. They are increasing 14.9% (CAGR) in the domestic consumption, and 44.0% (CAGR) in the export from 2011 to 2017, respectively. The proportion of IVD reagents, instrument, medical only used for animal and supplies were 54.2%, 41.0%, 3.8%, and 1.0%, respectively. The top 10 items with high sales were IVD reagents for clinical immunochemistry, visceral function testing instrument, hematological testing apparatus, syringes, IVD reagents for molecular genetics, etc. They are widely used from 3,926 animal hospitals in 2017. This study suggested that registration and sales of veterinary medical devices have gradually increased since 2013 as the demand of health care services for various animals. Therefore, the veterinary medical devices industry is expected to grow in the future.

• International journal of advanced smart convergence
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• 제2권2호
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• pp.40-42
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• 2013

Recent medical industry is an aging society and the application of national health insurance, with state-of-the-art research and development, including the pharmaceutical market is greatly increased. The nation's health care industry through new support expansion and improve the quality of life for the research and development will be needed. In addition, systemic administration of basic medical supplies, or drugs are needed, the drug at the same time managing how systematic analysis of pharmaceutical ingredients, based on data through the purchase of new medicines and pharmaceutical ingredients automatically classified by analyzing the statistics of drug purchases and the future a system that can predict a patient is needed. In this study, the drugs to the patient according to the component analysis and predictions for future research techniques, k-means clustering and k-NN (Nearest Neighbor) Comparative studies through experiments using the techniques employ a more efficient method to study how to proceed. In this study, the effects of the drugs according to the respective components in time according to the number of pieces in accordance with the patient by analyzing the statistics by predicting future patient better medical industry can be built.

• 대한수의학회지
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• 제55권2호
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• pp.97-103
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• 2015

In this study, the Korean veterinary medical devices management system was evaluated relative to systems in the USA, EU, and Japan. Veterinary medical devices are regulated in Korea based on the Medical Appliance Act of 1997. This was initially supervised by the Ministry of Agriculture, Food and Rural Affairs and Korea Animal Health Products Association, and subsequently by the Animal and Plant Quarantine Agency (QIA) in 2000. These devices were classified approximately 1,400 categories as instruments, supplies, artificial insemination apparatus, and other categories. Each of these devices was assigned to four regulatory grades by the QIA in 2007. The ranking system for veterinary medical devices was implemented in 2014 with 820 products from 162 companies registered by that year. However, in vitro diagnostic devices (IVDDs) for animals were managed as medical devices and biological medicine. In vitro diagnostic reagents for treating infection diseases are not subjected to either a classification or grading system. Veterinary medical devices are currently exempt from good manufacturing practices (GMP) and device tracking requirements. Due to gradual growth of the domestic veterinary medical devices market since 2008, regulation of these devices should be improved with re-examination of IVDDs and GMP certification for the effective operating system.

• Journal of Pharmaceutical Investigation
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• 제38권5호
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• pp.295-302
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• 2008

In the present study, we examined the changes of uptake and efflux of taurine under various conditions inducing oxidative stress using rat conditionally immortalized syncytiotrophoblast cell line, TR-TBT cell, as blood-placental barrier in vitro model. In addition, we identified the characteristics of taurine transport in TR-TBT cells including general features, besides effect of calcium ion on taurine transport. Taurine uptake showed time, $Na^+$ and $Cl^-$ dependency, and was decreased by PKC activator in TR-TBT cells. Also, calcium free condition decreased taurine uptake and evoked taurine efflux in the cells. Oxidative stress induced the change of taurine transport in TR-TBT cells, but the changes were different depending on the types of stimulation inducing oxidative stress. The taurine uptake was increased by TNF-$\alpha$, LPS and DEM stimulation but decreased by $H_2O_2$ and NO stimulation. Also, the taurine efflux was regulated by TNF-$\alpha$ stimulation. In conclusion, the taurine transport through the blood-placental barrier was regulated in oxidative stress conditions, and these results demonstrated that oxidative stress affected the taurine supplies to fetus and taurine level of fetus.

• 대한약학회:학술대회논문집
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• 대한약학회 2002년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2
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• pp.418.2-418.2
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• 2002

With the Sunshine policy. exchange of goods and cultures inter Koreas is broaden and expectancy of reunification is getting higher. Especially. medical supplies and medicines is one of the biggest parts in the exchanges. So. need for preparing new medical administration system for reunification is needed. We are going to compare inter Koreas drug administration system in medical services. (omitted)