• Journal of Life Science
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• v.29 no.7
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• pp.824-835
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• 2019

In recent decades, oncolytic viruses (OVs) have extensively been investigated as a potential cancer drug. Oncolytic viruses have primarily the unique advantage in the fact that they can only infect and destroy cancer cells. Secondary, oncolytic viruses induce the activation of specific adaptive immunity which targets tumor-associated antigens that were hidden during the initial cancer progression. In 2015, one genetically modified oncolytic virus, talimogene laherparepvec (T-VEC), was approved by the American Food and Drug Administration (FDA) for the treatment of melanoma. Currently, various oncolytic viruses are being investigated in clinical trials as monotherapy or in combination with preexistent cancer therapies like immunotherapy, radiotherapy or chemotherapy. The efficacy of oncolytic virotherapy relies on the balance between the induced anti-tumor immunity and the anti-viral response. Despite the revolutionary outcome, the development of oncolytic viruses for the treatment of cancer faces a number of obstacles such as delivery method, neutralizing antibodies and induction of antiviral immunity due to the complexity, variability and reactivity of tumors. Intratumoral administration has been successful reducing considerably solid tumors with no notable side effects unfortunately some tumors are not accessible (brain) and require a systemic administration of the oncolytic viruses. In order to overcome these hurdles, various strategies to enhance the efficacy of oncolytic viruses have been developed which include the insertion of transgenes or combination with immune-modulatory substances.

• Journal of Food Hygiene and Safety
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• v.24 no.3
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• pp.238-246
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• 2009

Acrylamide in various food samples in Korea were monitored during the period beginning August 2006 through May 2007. A total of 471 food products that were purchased at local markets were categorized into 17 groups and analyzed for the acrylamide content by using an LC-MS/MS method. Food samples that were selected based on special consideration such as expert consultation, Korean food consumption data and food market shares were considered to be representative. There are very large variations in acrylamide levels within tested foods. Acrylamide content ranged from ND(not detected) to $4,002{\mu}g$/kg with all tested samples. Acrylamide levels are relatively high in 'cereal', 'coffee', 'potato snacks', 'biscuit', 'chocolate', and 'prune juice'. Acrylamide was also detected in fruits, vegetables, Korean traditional cookies which are considered as safe for acrylamide.

• KSII Transactions on Internet and Information Systems (TIIS)
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• v.5 no.10
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• pp.1830-1840
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• 2011

CDISC (Clinical Data Interchanging Standards Consortium) standards are to support the acquisition, exchange, submission and archival of clinical trial and research data. SDTM (Study Data Tabulation Model) for Case Report Forms (CRFs) was recommended for U.S. Food and Drug Administration (FDA) regulatory submissions since 2004. Although the SDTM Implementation Guide gives a standardized and predefined collection of submission metadata 'domains' containing extensive variable collections, transforming CRFs to SDTM files for FDA submission is still a very hard and time-consuming task. For addressing this issue, we developed metadata based SDTM mapping rules. Using these mapping rules, we also developed a semi-automatic tool, named CDISC Transformer, for transforming clinical trial data to CDISC standard compliant data. The performance of CDISC Transformer with or without MDR support was evaluated using CDISC blank CRF as the 'gold standard'. Both MDR and user inquiry-supported transformation substantially improved the accuracy of our transformation rules. CDISC Transformer will greatly reduce the workloads and enhance standardized data entry and integration for clinical trial and research in various healthcare domains.

• Journal of Environmental Science International
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• v.17 no.8
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• pp.841-856
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• 2008

This research outlines a new method for evaluation of shellfish production in Gamak Bay based on the concept of EMERGY. Better understanding of those environmental factors influencing oyster production and the management of oyster stocks requires the ability to assess the real value of environmental sources such as solar energy, river, tide, wave, wind, and other physical mechanisms. In this research, EMERGY flows from environment sources were 76% for shellfish aquaculture in Gamak Bay. EMERGY yield ratio, Environmental Loading Ratio, and Sustainability Index were 4.26, 0.31 and 13.89, respectively. Using the Emergy evaluation data, the predicted maximum shellfish aquaculture production in Gamak Bay and the FDA (Food and Drug Administration, U.S.) designated area in Gamak Bay were 10,845 ton/y and 7,548 ton/yr, respectively. Since the predicted shellfish production was approximately 1.3 times more than produced shellfish production in 2005, the carrying capacity of Gamak Bay is estimated to be 1.3 times more than the present oyster production.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.21 no.10
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• pp.471-479
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• 2020

In this paper, we analyze features of radical innovative businesses using their patents. Although patents have been used to evaluate outcomes of businesses from the 1980s, it is challenging to use patents for radical innovations. We examined the possibility of taking advantage of patents for an indicator that represents a radical innovation in pharmaceutical industry. To this end, we collected FDA approval data from the U.S. Food and Drug Administration and patent data of 18 pharmaceutical companies. For analysis, we utilized the network centrality analysis and Wilcoxon signed ranked test, which is a non-parametric statistical hypothesis test used to compare two related samples. We observed that a radical innovative company typically cooperates with other research groups, such as universities and companies, and acts as a hub for connectivity in pharmaceuticals. Also, we found that there are differences in centrality between radical firms and non-radical firms. Thus, we expect that the results of this study will help in developing strategies for research and development of pharmaceutical companies and identifying factors affecting radical innovation in the future.

• 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.

• Korean journal of dermatology
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• v.56 no.10
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• pp.581-593
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• 2018

Atopic dermatitis (AD) is a common, chronic, relapsing, inflammatory skin disease that affects both children and adults. AD is the cause of considerable morbidity including severe pruritus and impaired quality of life. Treatments for active disease include avoidance of triggering factors, barrier repair, topical medications including topical corticosteroids (TCs) and topical calcineurin inhibitors (TCIs), phototherapy, antibacterial agents, and systemic immunosuppressants including cyclosporine. Until recently, the only Food and Drug Administration (FDA)-approved systemic treatment options for patients with moderate-to-severe AD were steroids and cyclosporine. Systemic steroids are not recommended by current guidelines and are commonly associated with disease rebound. Instead, clinicians choose from several off-label immunosuppressants. In 2018, the Korean FDA approved dupilumab for adults with moderate-to-severe AD whose disease is not adequately controlled with topical therapies. The implementation of treatment guidelines for AD is challenging. Herein, we review the several treatment modalities for AD and recommend a treatment algorithm.

• Journal of Microbiology and Biotechnology
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• v.16 no.5
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• pp.651-660
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• 2006

Natural products are a rich source of biologically active small molecules and a fertile area for lead discovery of new drugs [10, 52]. For instance, 5% of the 1,031 new chemical entities approved as drugs by the US Food and Drug Administration (FDA) were natural products between 1981 and 2002, and another 23% were natural product-derived molecules [53]. These molecules have evolved through millions of years of natural selection to interact with biomolecules in the cells or organisms and offer unrivaled chemical and structural diversity [14, 37]. Nonetheless, a large percentage of nature remains unexplored, in particular, in the marine and microbial environments. Therefore, natural products are still major valuable sources of innovative therapeutic agents for human diseases. However, even when a natural product is found to exhibit biological activity, the cellular target and mode of action of the compound are mostly mysterious. This is also true of many natural products that are currently under clinical trials or have already been approved as clinical drugs [11]. The lack of information on a definitive cellular target for a biologically active natural product prevents the rational design and development of more potent therapeutics. Therefore, there is a great need for new techniques to expedite the rapid identification and validation of cellular targets for biologically active natural products. Chemical genomics is a new integrated research engine toward functional studies of genome and drug discovery [40, 69]. The identification and validation of cellular receptors of biologically active small molecules is one of the key goals of the discipline. This eventually facilitates subsequent rational drug design, and provides valuable information on the receptors in cellular processes. Indeed, several biologically crucial proteins have already been identified as targets for natural products using chemical genomics approach (Table 1). Herein, the representative case studies of chemical genomics using natural products derived from microbes, marine sources, and plants will be introduced.

• Korean Journal of Clinical Pharmacy
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• v.26 no.2
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• pp.172-180
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• 2016

Background: Ischemic heart disease is the most common type of heart disease and an important cause of death in Korea. Among marketed anti-anginal medications, molsidomine, nicorandil, and trimetazidine are approved in Korea with unique mechanism of actions. As these drugs are not approved by the US Food and Drug Administration, the access to the up-to-dated and comprehensive safety-related information has been less than optimal from drug information resources used by Korean pharmacists. Methods: A systematic review was conducted using Embase and Korean manuscripts to compile safety updates for these medications. Out of 418 articles from keyword searches, 52 studies were reviewed in full to compare adverse effects (AEs) with the approved package inserts (PI). Results: Molsidomine related adverse effects were mostly mild or moderate, but anxiety, palpitation, epigastric pain, and sexual potency reduction were additional AEs found from the review not listed in PI. Although PI has included ulceration in oral cavity and gastrointestinal tracts including anus by nicorandil, the Korea FDA recently recommended adding corneal, genital, and skin ulcers to the approved PI. Trimetazidine induced Parkinsonism, worsening of the symptoms for patients diagnosed with Parkinson's disease, gastrointestinal burning, and muscle cramps were additionally identified AEs not listed in PI for trimetazidine. Conclusion: Continuous evaluations of the safety profile of these agents are needed to balance the risks and benefits to provide evidence-based safety counseling to the patients. In addition, more focused efforts on spontaneous reporting are warranted by healthcare professionals to safeguard patients against AEs.

• Journal of Dental Rehabilitation and Applied Science
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• v.38 no.1
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• pp.34-41
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• 2022

Recently, digital technology and computer-aided design/computer-aided manufacturing (CAD/CAM) environment have changed the clinician treatment method in the fabrication of dentures. The denture manufacturing method with CAD/CAM technology simplifies the treatment and laboratory process to reduce the occurrence of errors and provides clinical efficiency and convenience. In this case, complete dentures were fabricated using stereolithography (SLA)-based 3D printing in patient with mandibular deviation. Recording base were produced in a digital model obtained with an intraoral scanner, and after recording a jaw relation in the occlusal rim, a definitive impression was obtained with polyvinyl siloxane impression material. In addition, facial scan data with occlusal rim was obtained so that it can be used as a reference in determination of the occlusal plane and in arrangement of artificial teeth during laboratory work. Artificial teeth were arranged through a CAD program, and a gingival festooning was performed. The definitive dentures were printed by SLA-based 3D printer using a Food and Drug Administration (FDA)-approved liquid photocurable resin. The denture showed adequate retention, support and stability, and results were satisfied functionally and aesthetically.