• The Korean Society of Law and Medicine
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• v.22 no.1
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• pp.91-124
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• 2021

In May 2019, the Ministry of Food and Drug Safety revised the "Pharmaceutical Determination and Adjustment Criteria" with the content of differentially calculating the price of generic drugs according to the registration of the drug substance and meeting the requirements for their own bioequivalence test. According to this revised rule, if their own bioequivalence test is not conducted, even the generic drugs that have already been approved would be lowered in price. I wondered whether this system was introduced with sufficient public legal considerations regarding its legislative purposes and means. Therefore, I reviewed the contents of the revised notice based on whether or not it is valid to determine and adjust the price of generic drugs in terms of the legitimacy of legislative purposes and the proportionality principle after introducing the history and background of the rule. First, I raised a question as to whether the purpose of preventing the overrun of generic drugs is indeed legitimate in terms of the legitimacy of the purpose. In order for the revised notice of "reduction of drug prices when the test requirements are not met," to meet the conformity principle, the premise that it is difficult to recognize safety and effectiveness through consignment (joint) bioequivalence test or that these tests are insufficient in safety and efficacy verification than their own test must be established. Nevertheless, it seems that suffficient review has not been carried out. In order to achieve the purpose of securing safety and effectiveness, the focus should be on 'reinforcement of the standards for bioequivalence test and the management of the bioequivalence test itself' rather than whether it is a their own test or a consignment (joint) test. Third, it is contrary to the necessity and substantiality principle that strict standards are uniformly applied to the products that can be considered to have been sufficiently verified for safety and effectiveness after a considerable period of time has passed after the product approval. In many cases, revised administrative legislations quickly enacted and amended in the state of lack of legal review or consensus, while the regulatory effects resulting from it are quite direct and specific to the regulated person. In this respect, I emphasized that the administrative legislative process also requires substantial review and prior control of the regulatory purposes and means, and that the participation of stakeholders in the legislative procedure is to be strengthened.

• Journal of Digital Contents Society
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• v.18 no.4
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• pp.621-629
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• 2017

According to the rapid population aging and the increase of the number of people with chronic diseases, the digital healthcare services are getting more and more attention. Recent improvement in information technology has expanded the consumers of digital healthcare service from the patients to the general population. Therefore, there is a growing need for studies on the status and needs of digital healthcare users in general. This study conducted a survey of 1,000 people on their perception and attitude about four areas of digital healthcare: internet health information service, smartphone healthcare application, wearable device, and u-health. The questionnaire asked the respondents about their past experience of using digital healthcare services, the purpose of use and point to be improved. The respondents were also asked about new type and contents of digital healthcare service which they would like to use. The survey results will help developers of digital healthcare service by improving their understanding and identifying unmet needs from the general population.

• Journal of Digestive Cancer Reports
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• v.5 no.2
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• pp.97-104
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• 2017

Background: Cachexia is a multi-factorial syndrome presenting with chronic illness, decreases in body weight, and loss of adipose tissue and skeletal muscle, mostly in patients with advanced cancer and chronic wasting disease. Even after years of intensive researches, there remains no convincing therapy to prevent cancer cachexia. Methods: In this in vivo study, we have established C26 adenocarcinoma-induced cancer cachexia model in mice to explore the underlying core changes in cytokine, signal transduction, and muscle wasting. The ultimate aim of establishing animal model is to find optimal therapeutics to mitigate cancer cachexia. Results: We have administered C26 adenocarcinoma cells onto BALB/c mice and observed 4 weeks to assess the progression of cancer cachexia. Significant loss of weight accompanied with loss of appetite was noted. As C26 adenocarcinoma xenograft progressed, mortality was started from 3 weeks, accompanied with significant sarcopenia and decreased mice movement. Surges in TNF-α and IL-6 were noted with the commencement of cancer cachexia. Conclusion: Using C26 adenocarcinoma cancer cachexia model, we can screen the optimal therapeutics to mitigate cancer cachexia, in which agents to modulate IL-6, TNF-α, and NF-κB were essential.

• Journal of Digestive Cancer Research
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• v.5 no.2
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• pp.97-104
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• 2017

Background: Cachexia is a multi-factorial syndrome presenting with chronic illness, decreases in body weight, and loss of adipose tissue and skeletal muscle, mostly in patients with advanced cancer and chronic wasting disease. Even after years of intensive researches, there remains no convincing therapy to prevent cancer cachexia. Methods: In this in vivo study, we have established C26 adenocarcinoma-induced cancer cachexia model in mice to explore the underlying core changes in cytokine, signal transduction, and muscle wasting. The ultimate aim of establishing animal model is to find optimal therapeutics to mitigate cancer cachexia. Results: We have administered C26 adenocarcinoma cells onto BALB/c mice and observed 4 weeks to assess the progression of cancer cachexia. Significant loss of weight accompanied with loss of appetite was noted. As C26 adenocarcinoma xenograft progressed, mortality was started from 3 weeks, accompanied with significant sarcopenia and decreased mice movement. Surges in TNF-α and IL-6 were noted with the commencement of cancer cachexia. Conclusion: Using C26 adenocarcinoma cancer cachexia model, we can screen the optimal therapeutics to mitigate cancer cachexia, in which agents to modulate IL-6, TNF-α, and NF-κB were essential.

• Journal of agricultural medicine and community health
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• v.36 no.4
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• pp.227-237
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• 2011

Objectives: This study was conducted to investigate the utilization and its determinants of rehabilitation services of people with disabilities in a rural area. Methods: From March 2 to April 1, 2011, we interviewed 101 disabled people with either physical disabilities or brain lesions. The subjects completed questionnaires about the utilization of rehabilitation services, general characteristics (age, sex, marital status, education level, economic status, health insurance, housing, and employment) and disability characteristics (type, level, comorbidity, reason for the occurrence of the disability, self-rated degree of disability, and daily life care giver). Frequency, Pearson's chi-square test, and a multiple logistic regression were used for statistical analysis. Results: This study showed that 70.3% of the people in this rural area with disabilities were using rehabilitation services. The two most common reasons for not using the services were "doubt about the effectiveness of the service" and "no facilities nearby." The facilities that the disabled people were currently using, in the order of most used to least, were general hospitals or clinics, rehabilitation centers, oriental medicine clinics, and public health centers. Only 19.7% of those who received rehabilitation responded that they were satisfied with the service. Significant factors in the utilization of rehabilitation services were sex, employment, self-rated economic status, and the reason for the occurrence of the disability. Women, people who were currently working, people who were of middle or higher economic status, or people who had acquired a disability were significantly more likely to use the services. Conclusions: A large number of people with disabilities in a rural area use rehabilitation services at present, but accessibility and satisfaction were low. Quantitatively and qualitatively, rehabilitation services for disabled people in a rural area should be centered around Community-based Rehabilitation (CBR). Effective strategies, for example reaching those who have not used the rehabilitation services, will be needed to improve services in rural areas.