• Journal of Biomedical Engineering Research
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• v.44 no.6
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• pp.414-427
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• 2023

Implantable bioabsorbable combination products undergo inherent degradation and systemic absorption within the physiological environment, thereby streamlining the therapeutic regimen and obviating the imperative for invasive extraction procedures. This inherent property not only enhances patient convenience and therapeutic efficacy but also underpins a paradigm of support characterized by heightened safety parameters. Within the regulatory landscapes of Korea, the United States, and Europe, implantable bioabsorbable combination products are meticulously classified into distinct categories, either as pharmaceutical implants or as implantable medical devices, depending on their primary mode of action. This scholarly investigation systematically examines the regulatory frameworks governing implantable bioabsorbable combination products in South Korea, the United States, and Europe. Notable discrepancies across national jurisdictions emerge concerning regulatory specifics, including terminology, product classification, and product name associated with these products. The conspicuous absence of standardized approval regulations presents a formidable barrier to the commercialization of these advanced medical devices. This academic discourse passionately emphasizes the critical need for formulating and implementing a sophisticated regulatory framework capable of streamlining the product approval process, thereby paving the way for a seamless path to commercializing implantable bioabsorbable combination products.

• Journal of Legislation Research
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• no.41
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• pp.401-434
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• 2011

The discussion on the adoption of the horizontal regulatory framework is underway to overcome the problems regarding the vertical regulatory framework resulting from a convergence of broadcasting and telecommunications services. Recently, however, the horizontal regulatory framework shows its limitation to regulate the ecosystem established mainly by Google and Apple. The existing horizontal regulatory framework does not fully reflect the characteristics of the two-sided market and the change in the competition structure in the broadcasting and telecommunications sector. What is important to note is that if the existing horizontal regulatory framework is simply applied to the ecosystem, a regulatory imbalance can be caused among ecosystems. The existing horizontal regulatory framework, which is subject to a value chain structure, categorizes business entities into either contents layer or transmission layer and applies the same regulation to all business entities in the same category. However, in the ecosystem, a keystone-player can be categorized into different layers depending on its strategy. Therefore, if the existing horizontal regulatory framework is applied as it is, the regulatory imbalance between keystone-players located in less regulated areas and keystone-players located in more regulated areas occurs resulting in a distortion of competition. There are two possible ways to establish a new regulatory framework to prevent the distortion of competition likely to be caused by the adoption of a horizontal regulatory system. First, a new ecosystem regulatory framework different from the existing one can be established. Second, the horizontal regulatory framework can be modified to reflect the ecosystem elements. The first approach is hard to adopt given the current situation as the approach requires the analysis of all broadcasting and telecommunications ecosystems including mobile and wired services; currently research and study on the competition conditions in the ecosystems is not enough. Therefore, this paper supports the second approach proposing a modified horizontal regulatory framework through the improvement of institutions and remedies suitable for accommodating the ecosystem elements. This paper intends to propose a way to regulate broadcasting and telecommunications ecosystems taking into consideration the ecosystem elements on top of the Telecommunications Business Act, Broadcasting Act, IPTV Act, the competition condition evaluation system of the Basic Act on Broadcasting and Telecommunications Development, and regulation on common carriers under the Telecommunications Business Act.

• Journal of the Korean Society of Physical Medicine
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• v.6 no.3
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• pp.331-339
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• 2011

Purpose : The purpose of this study is to examine the impact of patient's psycological distress on social support in the view of patient's regulatory focus. Methods : For this study 300 questionnaires were distributed to medical institution, Busan from July 19 through August 4, 2010. The contents item divided the general characteristics, social support, psychological distress, and regulatory focus. The collected data were analyzed by t-test and multi-regression analysis. Results : The results show that patient's psychological distress is significantly influenced by physical therapist's emotional support and informational support. Also, there were difference with the effect of psychological distress on social supports in the physical therapists according to patient's regulatory focus. Conclusion : The instrumental support is more important to patient with promotion-focus than patient with prevention-focus. The implication of this research confirmed that physical therapist's social support plays important role in decreasing patient's psychological distress.

• IMMUNE NETWORK
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• v.7 no.1
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• pp.1-9
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• 2007

[ $CD4^+CD25^+$ ] regulatory T cells (Tregs) expressing the lineage-specific marker Foxp3 represent an important regulatory T cell that is essential for maintaining peripheral tolerance. Although it was believed that Treg development is solely dependent on the thymus, accumulating evidence demonstrates that Tregs can also be induced in the periphery. Considering the various origins of peripherally developed $CD4^+CD25^+Foxp3^+$ regulatory T cells, it seems likely that multiple factors are involved in the peripheral generation of Tregs.

• Journal of the Korean Data and Information Science Society
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• v.22 no.1
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• pp.125-136
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• 2011

Ground-level ozone, an air pollutant that is monitored by the Environmental Protection Agency (EPA), damages human health by irritating the respiratory system, reducing lung function, damaging lung cells, and aggravating asthma and other chronic conditions. In March 2008, the EPA strengthened ozone standards by lowering acceptable limits from 84 parts per billion to 75 parts per billion. Here epidemiologic data is used to study the effects of ozone regulation on human health and assessed how various regulatory standards for ozone may affect nonaccidental mortality, including respiratory-related deaths during ozone season. The assessment uses statistical methods based on hierarchical Bayesian models to predict the potential effects of the different regulatory standards. It also analyzes the variability of the results and ho they are impacted by different modeling assumptions. We focused on the technical an statistical approach to assessing relationship between new ozone regulations and mortality while other researches have detailed the relationship between ozone and human mortality. We shows a statistical correlation between ozone regulations and mortality, with lower limits of acceptable ozone linked to a decrease in deaths, and projects that mortality is expected to decrease by reducing ozone regulatory standards.

• Journal of Photoscience
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• v.5 no.4
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• pp.149-152
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• 1998

Expression of light-harvesting chlorophyll a/b-binding protein gene(cab) is repressed in the dark and activited by light. However, the detail of its regulatory mechanism is not characterized so far. To identify the interactions of cis-acting elements and trans-acting factors involvedin this regulation, nuclear extracts from the light-grown and dark-adapted Arabidopsis thaliana leaves were anlayzed for mobility shift assay against 134bp fragments had two retarded bands and one retardation band, respectively, both in light-grown and dark-adapted bands in the dark-adapted tissues. A new retardation the cab 3 expression in the dark. Several light regulatory motifs are scattered in the 146 bp region of cab 3 promoter. One of the light-regulatory motifs could be the binding site for the negative regulatory factor.

• Toxicological Research
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• v.17
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• pp.219-225
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• 2001

The basic structure for assessment of potential health risks from environmental chemicals is widely agreed upon, but many of the details of risk assessment procedures differ among practitioners. Government regulatory agencies typically have guidelines or standard procedures for their risk assessments, established to ensure consistency and comparability, to set standards for adequacy, and to embody underlying tenets. In setting and updating such guidelines, each agency takes into account not only the prevailing thinking about appropriate procedures, but also its own goals and responsibilities and the precedents it has set for itself in past analyses. This results in variations in methods, and consequently in characterization of risks, among regulatory assessments, even when they are based on the same data. As a result, adopting existing assessments from a variety of regulatory bodies needs to be done with caution. This paper examines some of the variants in risk assessment approaches among American federal regulatory agencies and relates them to the variations in regulatory responsibilities of those groups. Comparisons to international practices are also drawn. The impact on development of world-wide risk standards is discussed.

• Interdisciplinary Bio Central
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• v.1 no.1
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• pp.4.1-4.7
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• 2009

Introduction: Histone modifications and DNA methylation are the major factors in epigenetic gene regulation. Especially, revealing how histone modifications are related to DNA methylation is one of the challenging problems in this field. In this paper, we address this issue and propose several plausible mechanisms for precise controlling of DNA methylation status at CpG islands. Materials and Methods: To establish the regulatory relationships, we used 38 histone modification types including H2A.Z and CTCF, and DNA methylation status at CpG islands across chromosome 6, 20, and 22 of human CD4+ T cell. We utilized Bayesian network to construct regulatory network. Results and Discussion: We found several meaningful relationships supported by previous studies. In addition, our results show that histone modifications can be clustered into several groups with different regulatory properties. Based on those findings we predicted the status of methylation level at CpG islands with high accuracy, and suggested core-regulatory network to control DNA methylation status.

• Journal of Haehwa Medicine
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• v.25 no.1
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• pp.109-117
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• 2016

"Regulatory Function of Lung(肺主治節)" is one of the major function of lung, but its meaning is still controversial. The word "治節(Regulatory Function)" was first discovered in "黃帝內經(Huangdineijing)". In Chinese medicine text of modern China, physiological meaning of "治節" can be roughly divided into two; one is respiratory function, and another is to help cardiovascular function of the heart. In addition to this, "治節" has been construed in various ways, but all of them is not realistic. There has been several viewpoints that '節' in '治節' means 24 seasonal divisions and they can be representatively found in "東醫寶鑑(Donguibogam)". Based on all of these views, modern western medical physiology is requirement for further study about physiology of internal organs.

• Nuclear Engineering and Technology
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• v.37 no.3
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• pp.221-230
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• 2005

This paper reviews the pivotal phases of the evolution of the current technology-dependent nuclear power safety regulation in the United States. Understanding of this evolution is essential to the development of any future regulatory paradigm, including the technology-neutral regulatory approach that the U.S. Nuclear Regulatory Commission (NRC) has recently embarked on to develop. The paper proposes and examines the implications of a predominately rationalist and best-estimate probabilistic regulatory framework called safety goals-driven performance-based regulation. This framework relies on continuous assessment of performance of a set of time-dependent safety-critical systems, structures and components that assure attainment of a broad set of technology-neutral protective, mitigative, and preventive goals. Finally, the paper discusses the steps needed to develop a corresponding technology-neutral regulatory system from the proposed framework.