• The Korean Society of Law and Medicine
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• v.12 no.1
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• pp.257-285
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• 2011

This thesis has studied about the legal characteristic of injection of the trial drug, the position of the pharmaceutical firm as a contractor of the clinical trial, the possibility of compulsory performance of consistent injection of the trial drug, and the damage claim caused in the process of the clinical trial from the viewpoint of protecting the trial subject in the clinical trial. According to court's judgement in the United States, the lawsuit of the trial subject, although the trial subject had expected consistent injections, was dismissed because there was no direct contract between pharmaceutical and trial subject. However, Helsinki Declaration prescribe the medical research as follows. 'All patients who participated in the research should be able to use the best precaution, diagnosis, and treatment proved by the final outcome of the research'. The trial subject is entitled to demand only the pharmaceutical firm which developed and provided the trial drug, and the pharmaceutical firm has the obligation to supply the trial drug to the trial subject. Therefore, it would be not enough to protect the trial subject if the pharmaceutical firm which makes the trial drug is ruled out. In addition, especially, in case the trial drug has a constant effect with the aim of treatment, if the injection of the trial drug is suddenly stopped, the trial subject would not have the benefit of treatment by the trial drug. In this case, the best remedy against the damage is to urge a constant injection of the trial drug. Thus, in certain case, it is reasonable to consider that the pharmaceutical firm has the obligation to supply the trial drug to the trial subject constantly, and it is also necessary to compel it through effective means in case the pharmaceutical firm do not fulfill its obligation to supply the trial drug. However, as an essential prerequisite for the assertion mentioned above, it should be judged under the principle of good faith considering the concrete situation, that is, what roles the pharmaceutical firm has played.

• Communications for Statistical Applications and Methods
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• v.24 no.6
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• pp.561-581
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• 2017

Bayesian statistics can play a key role in the design and analysis of clinical trials and this has been demonstrated for medical device trials. By 1995 Bayesian statistics had been well developed and the revolution in computing powers and Markov chain Monte Carlo development made calculation of posterior distributions within computational reach. The Food and Drug Administration (FDA) initiative of Bayesian statistics in medical device clinical trials, which began almost 20 years ago, is reviewed in detail along with some of the key decisions that were made along the way. Both Bayesian hierarchical modeling using data from previous studies and Bayesian adaptive designs, usually with a non-informative prior, are discussed. The leveraging of prior study data has been accomplished through Bayesian hierarchical modeling. An enormous advantage of Bayesian adaptive designs is achieved when it is accompanied by modeling of the primary endpoint to produce the predictive posterior distribution. Simulations are crucial to providing the operating characteristics of the Bayesian design, especially for a complex adaptive design. The 2010 FDA Bayesian guidance for medical device trials addressed both approaches as well as exchangeability, Type I error, and sample size. Treatment response adaptive randomization using the famous extracorporeal membrane oxygenation example is discussed. An interesting real example of a Bayesian analysis using a failed trial with an interesting subgroup as prior information is presented. The implications of the likelihood principle are considered. A recent exciting area using Bayesian hierarchical modeling has been the pediatric extrapolation using adult data in clinical trials. Historical control information from previous trials is an underused area that lends itself easily to Bayesian methods. The future including recent trends, decision theoretic trials, Bayesian benefit-risk, virtual patients, and the appalling lack of penetration of Bayesian clinical trials in the medical literature are discussed.

• Smart Structures and Systems
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• v.21 no.3
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• pp.279-286
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• 2018

The free longitudinal vibration of a circular truncated nanocone is investigated based on the nonlocal elasticity theory. Exact analytical formulations for tapered nanostructures are derived and the nonlinear differential governing equation of motion is developed. The nonlocal small scale effect unavailable in classical continuum theory is addressed to reveal the long-range interaction of atoms implicated in nonlocal constitutive relation. Unlike most previous studies applying the truncation method to the infinite higher-order differential equation, this paper aims to consider all higher-order terms to show the overall nonlocality. The explicit solution of nonlocal stress for longitudinal deformation is determined and it is an infinite series incorporating the classical stress derived in classical mechanics of materials and the infinite higher-order derivative of longitudinal displacement. Subsequently, the first three modes natural frequencies are calculated numerically and the significant effects of nonlocal small scale and vertex angle on natural frequencies are examined. The coupling phenomenon of natural frequency is observed and it is induced by the combined effects of nonlocal small scale and vertex angle. The critical value of nonlocal small scale is defined, and after that a new proposal for determining the range of nonlocal small scale is put forward since the principle of choosing the nonlocal small scale is still unclear at present. Additionally, two different types of nonlocal effects, namely the nonlocal stiffness weakening and strengthening, reversed phenomena existing in nanostructures are observed and verified. Hence the opposite nonlocal effects are resolved again clearly. The nano-engineers dealing with a circular truncated nanocone-based sensors and oscillators may benefit from the present work.

• Advances in nano research
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• v.10 no.1
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• pp.15-24
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• 2021

Microtubules (MTs) are the main part of the cytoskeleton in living eukaryotic cells. In this article, a mechanical model of MT buckling, considering the modified strain gradient theory, is analytically examined. The MT is assumed as a cylindrical beam and a new single variable trigonometric beam theory is developed in conjunction with a modified strain gradient model. The main benefit of the present formulation is shown in its new kinematic where we found only one unknown as the Euler-Bernoulli beam model, which is even less than the Timoshenko beam model. The governing equations are deduced by considering virtual work principle. The effectiveness of the present method is checked by comparing the obtained results with those reported by other higher shear deformation beam theory involving a higher number of unknowns. It is shown that microstructure-dependent response is more important when material length scale parameters are closer to the outer diameter of MTs. Also, it can be confirmed that influences of shear deformation become more considerable for smaller shear modulus and aspect ratios.

• Journal of Korean Medical classics
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• v.34 no.2
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• pp.45-62
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• 2021

Objectives : To study the characteristics and meaning of the division pharmaceutical method in the Donguibogam through analysis of formulas that apply such method. Methods : Each formula applying the division method within the Donguibogam was analyzed Results & Conclusions : In the Donguibogam, medicinals to which the division pharmaceutical method was applied were baizhu[白朮], cangzhu[蒼朮], zhiqiao[枳殼], wuzhuyu[吳茱萸], xiangfuzi[香附子], chuanlianzi[川練子], huangbo[黃柏], etc. Formulas where this method was used were few, while the four methods that were used, together with the Center represents the principle of the five phases. The formulas that applied the division method usually did not adopt the tablet or decoction form, which means they were meant to treat slowly, treating deficiency or stagnation diseases due to problems in the middle-lower body such as the Spleen, Liver and Kidney. It could be said that compared to other more common formulas, this was a unique method. The division pharmaceutical method allows for usage of a wider variety of processing methods compared to single ingredient formulas, while there is lower chance of interference among the different types of processing. Another benefit is that the properties of the main medicinal ingredient could be preserved as much as possible. In addition, the division method allows for the main ingredient and the processed ingredient to interact exclusively, after which the processed medicinal is eliminated leaving only the main ingredient. This allows for maximum improvement of the main ingredient. The division method includes the principles of formula composition as well, whose concept could be positioned between single ingredient formulas and common formulas.

• Computers and Concrete
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• v.30 no.5
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• pp.311-321
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• 2022

The interfacial bond strength of partially encased composite (PEC) structure tends to 0, therefore, the cast-in-place concrete theoretically cannot embody better composite effect than the fabricated structure. A total of 12 specimens were designed and experimented to investigate the energy dissipation and damage of fabricated PEC beam through unidirectional cyclic loading test. Because the concrete on both sides of the web was relatively independent, some specimens showed obvious asymmetric concrete damage, which led to specimens bearing torsion effect at the later stage of loading. Based on the concept of the ideal elastoplastic model of uniaxial tensile steel and the principle of equivalent energy dissipation, the energy dissipation ductility coefficient is proposed, which can simultaneously reflect the deformability and bearing capacity. In view of the whole deformation of the beam, the calculation formula of energy dissipation is put forward, and the energy dissipation and its proportion of shear-bending region and pure bending region are calculated respectively. The energy dissipation efficiency of the pure bending region is significantly higher than that of the shear-bending region. The setting of the screw arbors is conducive to improving the energy dissipation capacity of the specimens. Under the condition of setting the screw arbors and meeting the reasonable shear span ratio, reducing the concrete pouring thickness can lighten the deadweight of the component and improve the comprehensive benefit, and will not have an adverse impact on the energy dissipation capacity of the beam. A damage model is proposed to quantify the damage changes of PEC beams under cyclic load, which can accurately reflect the load damage and deformation damage.

• Clean Technology
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• v.26 no.2
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• pp.151-157
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• 2020

Rapid urbanization has elevated the risk of urban flooding due to the increase in the impervious surface, causing environmental disasters and environmental pollution problems, such as lowering the groundwater level and increasing water pollution. In Korea, low impact development (LID) techniques have been introduced to minimize these environmental impacts and maintain the water cycle soundness. However, most small-scale development projects are in blind spots because there is no legal basis for rainfall runoff management. Small-scale development projects that increase the surface runoff of rainwater are required to mandate the application of LID facilities in accordance with the polluters' responsibility principle. Therefore, it is necessary to implement a preliminary consultation system for water cycle recovery. This study focuses on the cost-benefit analysis on the application of LID techniques for small-scale development projects. The scale of nationwide small-scale development projects used for cost-benefit analysis were defined as buildings with a land area of more than 1,000 ㎡ or a total floor area of 1,500 ㎡. As a result of analyzing the cost-benefits from the installation of LID facilities, they were found to be much lower than the economic standard value of 1. This might be due to the high cost of facilities compared to the scale of the project. However, considering the overall environmental value of improving the water environment and air quality by the installation of LID facilities and the publicity of reducing the operating cost of sewage treatment facilities, the introduction of a prior consultation for small-scale development projects is inevitable. In the future, institutional and financial support from local governments is required to improve the cost-benefits with the introduction of a prior consultation for small-scale development projects.

• The Korean Society of Law and Medicine
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• v.21 no.2
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• pp.163-207
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• 2020

Korea has been positioned as the leading country in the industry of clinical trials as the clinical trail of Korea has developed for the recent 10 years. Clinical trial has plays a significant role in the development of medicine and the increase of curability. However, it has inevitable risk as the purpose of the clinical trial is to prove the safety and effectiveness of new drugs. Therefore, the clinical trial should be controlled properly to protect the health of the subjects of clinical trial and to ensure that they exercise a right of self-determination. In this context, the fiduciary duties of doctors who conduct clinical trials is especially important. The Pharmaceutical Affairs Act and the relevant regulations define several duties of doctors who conduct clinical trials. In particular, the duty to protection of subjects and the duty to provide information constitute the main fiduciary duties to the subjects. Those are essentially similar to the fiduciary duties of doctors in usual treatment from the perspective of the values promoted by the law and the content of the law. Nonetheless, clinical trials put more emphasis on the duties to provide explanation than in usual treatment. Further research and study are required to establish the concrete standard for the duty of care. However, if the blind pursuit of higher standards for the duty of care or to pass the burden of proof to doctors may result in disrupting the development of clinical trials, limiting the accessibility of patients to new treatment and even violating the principle of sharing damage equally and properly. In addition to these duties, the laws of clinical trials define several duties of doctors. Any decision on whether the violation of the law constitutes the violation of the fiduciary duty and justifies the demand for compensation of damages should be based on whether relevant law aims to protect the safety and benefit of subjects, even if in an incidental way, the degree to which such violation breaches the values promoted by the law and the concrete of violation of benefit of law, the detailed acts of such violation. The legal interests of the subjects can be protected effectively by guaranteeing compliance with those duties and establishing judicial and administrative controls to ensure that the benefit of subjects are protected properly in individual cases.

• Journal of the Daesoon Academy of Sciences
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• v.38
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• pp.83-114
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• 2021

This paper identifies what the theoretical similarities and differences are in the concept of Sangsaeng held by Zhuxi (1130~1200) and Jeungsan (1871~1909). Human beings cannot live alone. For humans to survive, they must live with others. However, humans have an infinite desire not only for survival but also for material things, honor, and power. In other words, humans, on the one hand, seek harmony and symbiosis for survival, and on the other, constantly confront, conflict and compete with one another to satisfy their infinite desires. Thus, human-to-human interrelationship is not a co-prosperity that creates partnerships for harmony but one of adversaries within competition that must be fought and defeated. At the same time, humans can achieve harmony and cooperation by overcoming their infinite desires and realizing morality. Therefore, various social problems that originate from competitive structure, which are dominated by confrontation and conflict, can be solved through human effort and reflection, so that humans can focus on solving social problems by mobilizing their own wisdom. Jeungsan emphasized Sangsaeng as mutual beneficence and it became one of the creeds of Daesoon Thought. In the Neo-Confucianism of Zhuxi, there is an ideology of Sangsaeng as co-prosperity and this is comparable to mutual beneficence in Daesoon Thought. In Zhuxi's terminology it is called 'In (仁), humanity.' In Neo-Confucianism, a harmonious world is achieved by loving people and caring for and nurturing all things when the principles of humanity are realized. This means that when the principle of co-prosperity is realized in Daesoon Thought, there will be no conflict or grudges, and only an acquired vision of reconciliation and mutual beneficence will be achieved. Zhuxi also emphasizes the realization of humanity (cheonli) by eliminating self-interest. At this time, the relationship between humanity and 'self-interest' is similar to the relationship between the mutual beneficence and grievances in Daesoon Thought. Just as the principle of 'In' fosters love among people and the benefit of things immediately after self-interest is removed, the principle of mutual beneficence is realized immediately after grudges are resolved. This achieves an endless of paradise on earth.

• Journal of Energy Engineering
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• v.20 no.1
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• pp.63-76
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• 2011

This paper studies the impact of Korean introduction of the Generalized System of Preferences(GSP) to developing countries, which are continuously arguing to support research and development for reducing greenhouse gas(GHG) emission with developed countries in the Conference of the Parties(COP) of UNFCCC. This paper is focusing on the expecting effects of trade and GHG emission reduction when Korea provides GSP to Indonesia, Brazil, and Ethiopia, which are selected in the first session of Global Green Growth Institute(GGGI). This paper uses the methodology of the intra-industry trade index multiplied by Korean import-induced coefficients. To Indonesia, Korean probable GSP would benefit exports of Indonesian agriculture, forestry, fishery, and livestock farming industries, which would contribute to Indonesian reduction of GHG emission. To Brazil, the exports to Korea would increase in the GHG sensitive industries such as metal, fat, oils, food, and beverage industries. Ethiopia belongs to the least developed countries. So Korean GSP would support the exports and GHG reduction in Ethiopian agriculture, forestry, fisheries, textiles, and leather industries. Without conflicting most favored nation treatment(MFN) principle in WTO, the introduction of GSP would be a good compensation for GHG reduction to developing countries.