• Journal of Microbiology and Biotechnology
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• v.30 no.1
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• pp.11-20
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• 2020

Quercetin and its derivatives are important metabolites that belong to the flavonol class of flavonoids. Quercetin and some of the conjugates have been approved by the FDA for human use. They are widely distributed among plants and have various biological activities, such as being anticancer, antiviral, and antioxidant. Hence, the biosynthesis of novel derivatives is an important field of research. Glycosylation and methylation are two important modification strategies that have long been used and have resulted in many novel metabolites that are not present in natural sources. A strategy for modifying quercetin in E. coli by means of glycosylation, for example, involves overexpressing respective glycosyltransferases (GTs) in the host and metabolic engineering for increasing nucleoside diphosphate sugar (NDP-sugar). Still others have used microorganisms other than E. coli, such as Streptomyces sp., for the biotransformation process. The overall study of the structural activity relationship has revealed that modification of some residues in quercetin decreased one activity but increased others. This review summarizes all of the information mentioned above.

• The Journal of the Acoustical Society of Korea
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• v.29 no.3E
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• pp.119-130
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• 2010

Extracorporeal shock wave therapy (ESWT) is simply evolved from extracorporeal shock wave lithotripsy known as a revolutionary non-invasive technique for treating kidney stone diseases. Since ESWT was approved for treating plantar fasciitis by FDA in 2000, it has been rapidly accepted into various clinical practices. Its indication includes chronic tendinitis and pseudoarthrosis, and has been widened to various applications other than orthopeadics. Little has been reported on their acoustic properties, yet, even if a number of clinical ESWT systems are readily available. This article reviews the acoustical aspects of ESWT and discusses critical issues towards acoustic exposure optimization and shock wave dosimetry.

• The Korean Journal of Applied Statistics
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• v.25 no.4
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• pp.575-587
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• 2012

The effect of a new treatment is proven through the comparison of a new treatment with placebo; however, the number of parent non-inferiority trials tends to grow proportionally to the number of active controls. In a non-inferiority trial a new treatment is approved by proof that the new treatment is not inferior to an active control; however, both additional assumptions and historical trials are needed to show (through the comparison of the new treatment with the active control in a non-inferiority trial) that the new treatment is more efficacious than a putative placebo. The two different methods of using the historical data: frequentist principle method and meta-analytic method. This paper discusses the statistical methods and different Type I error rates obtained through the different methods employed.

• Biomedical Science Letters
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• v.25 no.3
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• pp.201-210
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• 2019

The oncolytic viruses selectively infect and destroy cancer cells, not harming normal cells. The cancer cell materials released by oncolysis, like tumor antigens, stimulate host antitumor immune responses, which is a long-lasting antitumor immunity removing cancer cells in remote parts of the body by a systemic response. Oncolytic viruses armed with transgenes such as cytokines or other immune stimulating factors enhance the immune responses. The first oncolytic virus approved by US-FDA is $Imlygic^{(R)}$ targeting for melanoma. The oncolytic virus is considered as a revolutionary immunotherapy for tumors together with immune checkpoint inhibitors. A variety of oncolytic viruses are under research in the treatment of kidney cancer, liver cancer, breast cancer, and many others solid tumors. Clinical trials have shown promising results in different types of cancers. Here, we present a brief introduction of various aspects of oncolytic virus, and a review of the current status of oncolytic virus therapy development.

• Journal of Powder Materials
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• v.28 no.6
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• pp.518-526
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• 2021

This review summarizes the recent progress in iron-oxide-based heat generators. Cancer treatment using magnetic nanoparticles as a heat generator, termed magnetic fluid hyperthermia, is a promising noninvasive approach that has gained significant interest. Most previous studies on improving the hyperthermia effect have focused on the construction of dopant-containing iron oxides. However, their applications in a clinical application can be limited due to extra dopants, and pure iron oxide is the only inorganic material approved by the Food and Drug Administration (FDA). Several factors that influence the heat generation capability of iron-oxide-based nanoparticles are summarized by reviewing recent studies on hyperthermia agents. Thus, our paper will provide the guideline for developing pure iron oxide-based heat generators with high heat dissipation capabilities.

• Journal of Integrative Natural Science
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• v.15 no.4
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• pp.171-177
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• 2022

ROS1 (c-ros oncogene) is one of the gene with mutation in NSCLC (non-small cell lung cancer). The increased expression of ROS1 is leading to the increase proliferation of cell, cell migration and survival. Crizotinib and Entrectinib are the drugs that have been approved by FDA against ROS1 protein, but recently patients started to develop resistance against Crizotinib and there is a need of new drug that could act as an effective drug against ROS1 for NSCLC. In this study, we have performed virtual screening, where compounds are taken from Zinc 15 dataset and molecular docking was performed. The top compounds were taken based upon their binding affinity and their interactions with the residues. The compounds stability and chemical reactivity was also studied through Density Functional theory and their properties. Further study of these compounds could reveal the required information of ROS1-inhibitor complex and in the discovery of potent inhibitors.

• Journal of Physiology & Pathology in Korean Medicine
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• v.19 no.5
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• pp.1267-1271
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• 2005

To investigate the effect of the frequently used anti-obese medicine GyeongshinhaeGihwan 1 (GGT1), in food intake, body weight and food efficiency ratio for high fat diet induced obese male rats. Also, to value the diffences between GyeogshinhaeGihwan 1 and FDA approved Sibutramine in anti-obesity effect. High fat diet induced obese male rats were classified into four groups - positive control group, negative control group, GyeongshinhaeGihwan 1 group and Sibutramine group - and their food intake and body weight were observed for eight weeks. Anti-obesity effect was estimated with food efficiency ratio which is calculated by weight inclose divided by food intake. The result shown in Fig. 2 suggests that the GyeongshinhaeGihwan 1 group is more effective on food intake control than the Sibutramine group. Average weight variation shows an increase in both positive/negative control group and medication group. Also, the result in Fig. 3 indicates that average food efficiency ratio decreases contrary to the average weight variation. In addition, repeatedly estimated variance analysis on average food efficiency ratio of the GyeonushinhaeGihwan 1 group shows (1) the result corollary to the time of observation of food efficiency ratio was effective under 0.05 variance (P-value 0.000). The differences between each groups were not shown under 0.05 variance. Compared to the control group, medication groups were visually more effective on food intake control. Although both groups had a tendency of weight increasing, food efficiency ratio considering food intake and weight variation rate showed a decrease. Especially, the medication group variated less than the control group corollary to the point of time, proving the individuals react less sensitive to the medicine. Moreover, there were no differences in the anti-obesity effect between GyeongshinhaeGihwan 1 group and Sibutramine group studied by repeatedly estimating variance analysis(P-value: 0.610). When considering Sibutramine as an anti-obesity medicine approved by FDA, the point of being classifed in the same group proves the effect of GyeongshinhaeGihwan 1 as an anti-obesity medicine.

• YAKHAK HOEJI
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• v.56 no.3
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• pp.204-209
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• 2012

The purpose of this study was to construct database for a drug safety information website to serve as an access point of up-to-date resources for a wide variety of drug-safety information helping patients and healthcare professionals make well-informed decisions about medication use. All the contents developed were confirmed by the council of advisors who were the experts in drug safety. The detailed contents of database on frequently prescribed drug including 9 NSAIDs, 19 antibiotics, 24 cardiovascular, 21 metabolic, 14 respiratory, 20 digestive, 22 hormonal, 10 genitourinary, 10 anti-allergic, 27 antifungal/antiviral, and 71 neuropsychiatric agents were developed based on the approved drug labeling of the Korean FDA. A separately searchable database of drug-specific safety information for patients and health professionals was constructed for users in need of different depth of knowledge on using medications safely. The safety information on highly prevalent chronic diseases and drug classes was also developed. Finally the most recent global drug safety news was provided. The consumer directed information was developed in layman's terms as means of proving user-friendly information. The creation of this type of website is part of the Korean FDA's ongoing initiative to address and promote the safe use of medications for the public.

• Journal of Integrative Natural Science
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• v.4 no.4
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• pp.315-322
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• 2011

This study was performed to investigate the current regulatory guidances of safety and efficacy evaluation for the approval of stereoisomeric drugs in Korea and US. According to the regulatory guidelines in major countries (EU, Canada, US), the important categories for the development of stereoisomeric drugs are classified as 1) development of a single enantiomer as a new active substances 2) development of a racemate as a new active substance 3) development of a new single enantiomer from an approved racemate. For this study, domestic regulatory documents for current guidelines of stereoisomeric drugs were investigated. Also four typical stereoisomeric drugs for three categories were chosen to investigate the new drug submission documents of KFDA and FDA for the safety and efficacy evaluation of stereoisomeric drugs. It is expected that these comparative results between KFDA and FDA will be useful for the safety and efficacy for the regulatory approval of stereoisomeric drugs in Korea.

• Korean Journal of Transplantation
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• v.31 no.4
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• pp.157-169
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• 2017

Regulatory T cells (Treg) naturally rein in immune attacks, and they can inhibit rejection of transplanted organs and even reverse the progression of autoimmune diseases in mice. The initial safety trials of Treg against graft-versus-host disease (GVHD) provided evidence that the adoptive transfer of Treg is safe and capable of limiting disease progression. Supported by such evidence, numerous clinical trials have been actively investigating the efficacy of Treg targeting autoimmune diseases, type I diabetes, and organ transplant rejection, including kidney and liver. The limited quantity of Treg cells harvested from peripheral blood and subsequent in vitro culture have posed a great challenge to large-scale clinical application of Treg; nevertheless, the concept of CAR (chimeric antigen receptor)-Treg has emerged as a potential resolution to the problem. Recently, two CAR-T therapies, tisagenlecleucel and axicabtagene ciloleucel, were approved by the US FDA for the treatment of refractory or recurrent acute lymhoblastic leukemia. This approval could serve as a guideline for the production protocols for other genetically engineered T cells for clinical use as well. The phase I and II clinical trials of these agents has demonstrated that genetically engineered and antigen-targeting T cells are safe and efficacious in humans. In conclusion, both the promising results of Treg cell therapy from the clinical studies and the recent FDA approval of CAR-T therapies are paving the way for CAR-Treg therapy in clinical use.