• Mass Spectrometry Letters
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• v.11 no.1
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• pp.10-14
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• 2020

Riboflavin is a water-soluble vitamin, which serves as a precursor to flavin mononucleotide and flavin adenine dinucleotide. This study aimed to develop a simple and rapid liquid chromatography-tandem mass spectrometry (LC-MS/MS) analysis for the quantification of riboflavin in the Beagle dog plasma. This method utilized simple protein precipitation with acetonitrile and ¹³C₄, ¹⁵N₂-riboflavin was used as an internal standard (IS). For chromatographic separation, a hydrophilic interaction liquid chromatography (HILIC) column was used with gradient elution. The mobile phase consisted of 0.1% (v/v) aqueous formic acid with 10 mM ammonium formate and acetonitrile with 0.1% (v/v) formic acid. Since riboflavin is an endogenous compound, 4% bovine serum albumin in phosphate buffered saline was used as a surrogate matrix to prepare the calibration curve. The quantification limit for riboflavin in the Beagle dog plasma was 5 ng/mL. The method was fully validated for its specificity, sensitivity, accuracy and precision, recovery, and stability according to the US FDA guidance. The developed LC-MS/MS method may be useful for the in vivo pharmacokinetic studies of riboflavin.

• The Journal of Korean Physical Therapy
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• v.23 no.3
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• pp.37-42
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• 2011

Purpose: The principal objective of this study was to evaluate the power output of ultrasound in Korean clinics and compare the value with Korean and global standards. Methods: A total of 69 units were measured for ultrasound power output. The normal range of power output level was ${\pm}30%$ of the output set according to KFDA standards. Device model, manufacturer, ERA, and BNR were obtained via simple questionnaires. A portable ultrasound power meter was used for output measurement. Results: 37 machines, with reported ERA values, were assessed for power output per unit area. Of these machines, 13 (37.14%) were considered to be compliant with US FDA standards at 0.5, 1.0, 1.5, $20W/cm^2$ and 18 (51.43%) were considered within KFDA standards. The remainder of the machines were outside the standard error and evidenced irregular output levels, even though most of them were the same model. Conclusion: Appropriate ultrasound intensity is incredibly important for safety and effective use. Therefore, the KFDA standards regarding ultrasound may require revision in light of global standards, including BNR and ERA additionally, attention should be paid to regular calibration for safe use in clinical practice.

• Radiation Oncology Journal
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• v.36 no.4
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• pp.265-275
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• 2018

Cancer is a complex multifaceted illness that affects different patients in discrete ways. For a number of cancers the use of chemotherapy has become standard practice. Chemotherapy is a use of cytostatic drugs to cure cancer. Cytostatic agents not only affect cancer cells but also affect the growth of normal cells; leading to side effects. Because of this, radiotherapy gained importance in treating cancer. Slaughtering of cancerous cells by radiotherapy depends on the radiosensitivity of the tumor cells. Efforts to improve the therapeutic ratio have resulted in the development of compounds that increase the radiosensitivity of tumor cells or protect the normal cells from the effects of radiation. Amifostine is the only chemical radioprotector approved by the US Food and Drug Administration (FDA), but due to its side effect and toxicity, use of this compound was also failed. Hence the use of herbal radioprotectors bearing pharmacological properties is concentrated due to their low toxicity and efficacy. Notably, in silico methods can expedite drug discovery process, to lessen the compounds with unfavorable pharmacological properties at an early stage of drug development. Hence a detailed perspective of these properties, in accordance with their prediction and measurement, are pivotal for a successful identification of radioprotectors by drug discovery process.

• Journal of Platform Technology
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• v.10 no.1
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• pp.20-28
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• 2022

Artificial intelligence-based health data verification has become an essential element not only to help clinical research, but also to develop new treatments. Since the US Food and Drug Administration (FDA) approved the marketing of medical devices that detect mild abnormal diabetic retinopathy in adult diabetic patients using artificial intelligence in the field of medical diagnosis, tests using artificial intelligence have been increasing. In this study, an artificial intelligence model based on image classification was created using a Teachable Machine supported by Google, and a predictive model was completed through learning. This not only facilitates the early detection of cataracts among eye diseases occurring among patients with chronic diseases, but also serves as basic research for developing a digital personal health healthcare app for eye disease prevention as a healthcare program for eye health.

• Korean Chemical Engineering Research
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• v.55 no.2
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• pp.180-189
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• 2017

Pharmaceutical co-crystals primarily to improve the solubility as well as stability of insoluble drug are to be investigated more intensively for IMDs as US FDA has reclassified co-crystal as a special case of solvates in August this year. In this study, we proposed a mechanism of indomethacin-saccharin co-crystal formation and the creation of transient indomethacin meta-stable form using in-line monitoring tools with the addition rate of anti-solvent as a critical process parameter. Among various instruments, we combined PVM (particle vision measurement) and FBRM (focused beam reflectance measurement) for the in-line monitoring of anti-solvent co-crystallization process. The off-line characterization of resulting powders was carried out employing the PXRD (powder x-ray diffraction) and DSC (differential scanning calorimeter). It was observed that the pathway to the final IMC-SAC co-crystal was significantly dependent upon the anti-solvent addition rate. The process conditions to obtain high quality co-crystal powder effectively were established. Consequently, we concluded that in-line monitoring combing the PVM and FBRM should be useful for the in-line monitoring of pharmaceutical co-crystallization processes.

• Microbiology and Biotechnology Letters
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• v.42 no.1
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• pp.1-10
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• 2014

Most microorganisms have been used for foods for such a long period of time with no question posed for their safety. However, the progress of food processing technology has activated international food trades, and the consumers and authorities of import countries have come to question the safety of microorganisms used in foods. At present, the most widely known safety standards are Generally Recognized as Safe (GRAS) status from the US Food and Drug Administration (FDA) and Qualified Presumption of Safety (QPS) status by the European Food Safety Authority (EFSA). GRAS status is not for the safety of microorganisms themselves but for the permissibility of strains or cultures in specific food uses. QPS provides a qualified generic approval to a defined taxonomic unit. The increase of commercialized traditional fermented foods in Korea has spurred the starter development for traditional food fermentations. However, starter development in Korea has been carried out based on the technological properties of microorganisms with no research on developing a standardized tool for safety assessment. In the globalization of traditional Korean fermented foods, technological properties as well as safety of future starters should be guaranteed, and establishment of the safety assessment regulation for microorganisms used for foods is necessary.

• The Journal of the Korea Contents Association
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• v.19 no.3
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• pp.365-374
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• 2019

Unlike benign tumors, malignant tumors are capable of metastasis, easy to relapse, poor survival, and low quality of life. In Korea, here is a tendency to treat the tumors collectively according to the General Principles of Cancer Chemotherapy(GPCC) of the Health Insurance Review & Assessment Service (HIRA). But recently, companion diagnostics(CDx) is recommended rather than unilateral medication because biomarker-based molecular diagnostics is possible to predict the drug response of patients before drug treatment. Not only domestic but also overseas Food and Drug Administratio (FDA) recommends the development of the CDx system at the stage of drug development to ensure the responsiveness and safety of medicines. In this study, I focused on the necessity of CDx development direction as well as CDx development status through literature review. Furthermore I also discussed CDx types according to the molecular diagnostic technology such as immunohistochemistry (IHC), polymerase chain reaction (PCR), in situ hybridization (ISH), and next-generation sequencing (NGS) not only in the approved CDx but also in the developing one by US FDA. And I suggested the technology issue of CDx development process such as a selection of molecular diagnostics at the time of release, a clear understanding of the CDx mechanism, and a convergence of drug with CDx development. The necessity of social insurance system also was proposed for CDx development.

• The Journal of the Convergence on Culture Technology
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• v.9 no.2
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• pp.525-531
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• 2023

In Korea, which is entering a super-aged society, the number of elderly patients who have difficulty walking independently is expected to increase rapidly, and it is necessary to develop wheelchair products with various functions to improve the quality of life of people with walking disabilities. Recently, wheelchair power assist devices that provide propulsion power by being attached to a manual wheelchair has been developed and is entering the domestic and global markets. In this study, we compared and analyzed the process of obtaining medical device certification for wheelchair power assist devices in Korea, the United States, and Europe. In Korea, a Class 2 medical device certification process was developed in 2021, and in the US FDA, it corresponds to Class 2 like the existing electric wheelchair and must pass the 510k certification process. In the case of Europe, it is uniquely regulated as Class I, and the CE mark can be attached through a relatively easy self-declaration of conformity. The Korean medical device industry, which is struggling with MDR certification, a new European medical device regulation, should pay attention to the relatively easy entry into the global market for wheelchair power assist products.

• Journal of Biomedical Engineering Research
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• v.37 no.4
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• pp.134-139
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• 2016

US Food and Drug Administration (FDA) approved as a innovative cure for cancer, 1996. The effect is death of cancer cells through necrosis, apoptosis. Mainly the Continuous Wave mode (CW) use for PDT Laser. It sting, the question including itch, and etc. Reportedly, the increase of temperature with the perforated edema, ulcer, necrosis. The Thermal relaxation time and Oxygen recovery time is necessary. To give a normal oxygen recovery time of the cell, used Pulse mode. Progress, it was Burst Pulse mode when easing the thermal wake, the simplicity was secured, the PDT effect is good. Excepted in control group CW, Pulse, Burst pulse mode were incubated with various concentrations of 5-aminolevulinic acid hydrochloride (ALA-5). The tumor size reduction CW mode (44%), Pulse mode (48%), Burst pulse mode (53%) at 4 week after PDT with 0.3, 0.3, 0.3 mg/ml of ALA-5. After 4 hours, investigation of 100, 100, $100J/cm^2$ laser irradiation. The pulse mode was superior in expirimental data analysis. And it was the Burst pulse mode edge head of a family effect.

• 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.