• 분석과학
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• 제37권3호
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• pp.143-154
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• 2024

건강기능식품공전은 기능성 원료의 지표(기능)성분에 대해 시험법을 고시하고 있다. 본 연구에서는 공전에서 제공하는 비타민C 시험법을 개선하고 정량을 위한 크로마토그래프법 조건의 조정 가능 범위에 대한 데이터를 검토하였다. 우선적으로 이동상 조건인 용매 조성, 염 농도, pH, 컬럼 온도를 조정해 보았으며, 특히 pH의 조절에 따라 완충용액으로부터 유래한 피크가 목적 성분인 비타민C와 명확히 분리될 수 있음을 개선된 시험법으로 확인하였다. 고정상 규격인 컬럼 내경, 컬럼 길이 및 고정상 입자 크기의 조정에 따라 성분의 머무름시간이 일부 조정되었으나, 이론단수는 유사한 수치를 나타냄으로써 목적 성분의 분리 및 정량적 분석에 영향을 주지 않았다. 변경된 컬럼 규격에 따른 유량 변경식은 USP <621> Chromatography 및 국내 식품의약품안전처의 [의약품 등 시험방법 밸리데이션 가이드라인 해설서]에서 제시하는 공식을 근거로 컬럼 규격(내경, 길이, 입자 크기)을 고려한 새로운 공식을 도출하였으며, 비타민 복합제에 대한 적용성 평가 결과, 변경된 고정상 및 유량에도 비타민C에 대한 높은 선택성을 보였다. 결론적으로, 크로마토그래프법 조건 일부의 변경을 통해서 비타민C를 최적으로 분리 및 검출할 수 있음을 확인하였으며, 등용매 용리를 활용하는 시험법에서 액체크로마토그래피의 이동상 및 고정상 조건을 조정 가능함을 확인하였다.

• 대한치과의사협회지
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• 제48권4호
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• pp.256-262
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• 2010

bone grafting is indicated in the case of bony defects and is classified into autograft, allograft, and xenograft. Synthetic bone graft is contrasted with these three categories in that it has a different donor source. Autograft is most prominent as it is known as a gold standard of all grafting procedures. Its principles and practices are well established via accumulated informations and clinical experiences, which imposes no regulations or restrictions in its clinical use. On the other hand, other bone graft procedures are under tight control for the safety and effectiveness of each product. Food and Drug Administration of the United States has a system in which the information on the approvals and clearances of bone graft materials on their internet homepage. All the bone graft materials that are under the regulations of the United States are classified into the category of medical devices, which includes allogenic bone, xenogenic bone, and synthetic bone graft materials. Each bone graft material has its own indication and the FDA approvals and clearances of medical devices contain the item of "intended use" to specify the indications of each bone graft materials. US dentists, as users of the specific bone graft materials, are provided with adequate information on the approved materials they are to utilize. As an user of these materials, Korean dentists are less provided with the information on the bone graft materials they want to use. Medical providers of the bone graft materials have to be able to provide their users with the essential information such as the intended use of the regulatory approval. Dentists must also be active in gathering informations on the material of their interest, and the system must be built in which both of the medical providers and users of bone graft materials can be satisfied in providing and getting the information, respectively.

• 한국환경보건학회지
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• 제36권2호
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• pp.118-127
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• 2010

Bivalve samples from 30 locations Korean coastal waters were analyzed to characterize the contamination with and distribution of polybrominated diphenyl ethers (PBDEs), polychlorinated biphenyls (PCBs) and organochlorine pesticides (OCPs). The congeners of PBDE in 30 bivalve samples were analyzed by high resolution gas chromatography with a high resolution mass detector. The levels of PBDEs in bivalve samples ranged from 0.092 to 13.5 ng/g wet weight. These values for PBDEs concentrations in bivalves from Korea were higher than or comparable to available values for bivalves from other countries. In the congener profiles, BDE-47 (mean contribution=42.2%) was predominant, followed by BDE-99 (23.1%), BDE-100 (11.9%) and BDE-154 (3.5%). Among the OCs analyzed, $\Sigma$PCBs and $\Sigma$DDTs levels were highest, followed by $\Sigma$HCHs, $\Sigma$CHLs and HCB. The wet weight based $\Sigma$PCBs and $\Sigma$DDTs ranged from 0.28 ng/g to 19.4 ng/g, and from 0.19 ng/g to 4.86 ng/g, respectively. The $\Sigma$PCBs and $\Sigma$DDT slevels in bivalves along the entire Korean coast were lower than those of the USA, and below the Food and Drug Administration (USA. FDA) limits for fish and shell fish. However, the human health criteria and wild life criteria of the USA. Environmental Protection Agency (USA. EPA) were exceeded for DDE and $\Sigma$HCHs at most of the sampling points.

• 한국임상약학회지
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• 제28권1호
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• pp.65-75
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• 2018

Objective: Over the last several years, immunotherapy has become one of the most promising therapeutic options for cancer. This study aims to summarize the updates on cancer immunotherapy focusing on immune checkpoint inhibitors, such as programmed cell death-1 (PD-1), programmed death-ligand 1 (PD-L1), and cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitors, which have received attention as new anticancer therapeutic agents. Methods: A literature survey was carried out on PubMed to identify high-impact papers on cancer immunotherapy from 2010. The most recent data on clinical efficacy and safety have been included highlighting the response characteristics to recently approved immunotherapeutic agents. Results: In various cancers, immune checkpoints are a means for cancer cells to evade the immune system. Furthermore, CTLA-4 and PD-L1 can be overexpressed, allowing malignant cells to evade T-cells. Numerous clinical trials have been performed to seek appropriate indication of these products in various cancer types. Among them, the most conspicuous types are melanoma, non-small-cell lung cancer, and head and neck cancer. The approval of ipilimumab by Food and Drug Administration (FDA) commenced a new era of cancer immunotherapy. This was followed by the approval of nivolumab and pembrolizumab. Currently, combination therapies are being investigated for various cancer types. Conclusion: In this study, we reviewed recently reported scientific and clinical evidence for currently approved immune checkpoint inhibitors. Although these novel checkpoint inhibitors are ever evolving for cancer therapies, there exist limitations that need to be overcome, indicating the necessity for further studies aiming to improve their efficacy, toxicity, and cost.

• 대한의용생체공학회:의공학회지
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• 제41권6호
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• pp.228-234
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• 2020

Superparamagnetic iron oxide nanoparticles (SPIONs) are approved by the Food and Drug Administration (FDA) in the United States. SPIONs are used in magnetic resonance imaging (MRI) as contrast agents and targeted delivery in nanomedicine using external magnet sources. SPIONs act as an artificial peroxidase (i.e., nanozyme), and these reactions were highly stable in various pH conditions and temperatures. In this study, we report a nanozyme ability of the clustered SPIONs (CSPIONs) synthesized by the oil-in-water (O/W) method and coated with biocompatible poly(lactic-co-glycolic acid) (PLGA). We hypothesize that the CSPIONs can have high sensitivity toward H2O2 derived from the reaction between a fixed amount of glucose and glucose oxidase (GOX). As a result, CSPIONs oxidized a 2,2'-azino-bis(3-ethylbenzthiazoline-6-sulfonic acid) diammonium salt (ABTS) commonly used as a substrate for hydrogen peroxidase in the presence of H2O2, leading to a change in the color of the substrate. We also utilized a colorimetric assay at 417 nm using various glucose concentrations from 5 mM to 1.25 μM to validate β-D-glucose detection. This study demonstrated that the absorbance value increases along with increasing the glucose level. The results were highly repeated at concentrations below 5 mM (all standard deviations < 0.03). Moreover, the sensitivity and limit of detection were 1.50 and 5.44 μM, respectively, in which CSPIONs are more responsive to glucose than SPIONs. In conclusion, this study suggests that CSPIONs have the potential to be used for glucose detection in diabetic patients using a physiological fluid such as ocular, saliva, and urine.

• 방사선산업학회지
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• 제17권4호
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• pp.417-425
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• 2023

Lutetium(¹⁷⁷Lu), with its theranostic properties, is one of the most widely used radioisotopes and has a large share of the radiopharmaceutical market due to its many applications and targeted therapeutic research using lutetium-based radiopharmaceuticals. However, lutetium-based radiopharmaceuticals currently approved by the US Food and Drug Administration (FDA) are limited to the indications of gastrointestinal cancer, pancreatic neuroendocrine cancer and metastatic castration-resistant prostate cancer. To overcome these limitations, we aimed to demonstrate the feasibility of expanding the use of lutetium-based radiopharmaceuticals by verifying the availability and therapeutic efficacy of lutetium produced in a research reactor(HANARO). In this study, we confirmed the therapeutic efficacy of lutetium by using cancer cells from different types of cancer. In addition, we selected cancer biomarkers based on characteristics common to various cancer cells and compared and evaluated the therapeutic efficacy of lutetium by regulating the expression of target genes. The results showed that modulation of cancer biomarker gene expression resulted in higher therapeutic efficacy compared to lutetium alone. In conclusion, this study verified the potential use and therapeutic efficacy of lutetium based on the production of a research reactor (HANARO), providing fundamental evidence for the development of lutetium-based radiopharmaceuticals and the expansion of their indications.

• 대한의용생체공학회:의공학회지
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• 제37권4호
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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.

• 대한방사성의약품학회지
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• 제6권2호
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• pp.61-68
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• 2020

Aggregated neurofibrillary tangles (NFTs) are a pathological hallmark in Alzheimer's disease (AD) and many radiopharmaceuticals targeting NFTs have been developed so far. Among these, [¹⁸F]flortaucipir (TAUVID^TM) is the first approved radiopharmaceutical in the Food and Drug Administration (FDA) to image tau pathology. In the present study, we describe the optimized radiosynthetic method for the routine production of [¹⁸F] flortaucipir using a commercialized automation module (i.e. GE TRACERlab^TM FX_FN pro). [¹⁸F]Flortaucipir was prepared by nucleophilic substitution from its N-tert-butoxycarbonyl protected nitro precursor, tertbutyl 7-(6-nitropyridin-3-yl)-5H-pyrido[4,3-b]indole-5-carboxylate, at 130℃ for 10 min in dimethyl sulfoxide. The mean radiochemical yield was 20 ± 4.3% (decay-corrected, n = 47) with the molar activity of 218 ± 32 GBq/µmol at the end of synthesis. The radiochemical purity was determined to be above 95%. The overall production time including quality control is approximately 100min. The final produced [¹⁸F]flortaucipir injection meets the USP criteria for quality control. Thus, this fully automated system is validated for clinical use.

• 한국임상약학회지
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• 제31권4호
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• pp.257-267
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• 2021

Background: The need for regulatory science development to evaluate advanced regulatory products is gradually increasing without hindering the technological development. Creating a research environment and fostering experts through the establishment of regulatory agency-led policies are essential for the development of regulatory science. Method: This is a comparative study of the United States, Japan, Singapore, and Korea. The literature and websites of each regulatory agency were reviewed, and the focus was on advantages and comparing advantages based on definition, development trends, and expert training projects. Results: The United States is striving to develop regulatory science in response to changes in the new pharmaceutical industry through the regulatory science report, and to foster expert both inside and outside the Food and Drug Administration (FDA). Japan is promoting regulatory science centered on regulatory science centers, and is focusing on researching work-related regulatory science within the Pharmaceuticals and Medical Devices Agency (PMDA) and improving employees' ability to make regulatory decisions. Singapore was aiming to improve Southeast Asia's regulatory capabilities under the leadership of Centre of Regulatory Excellence (CoRE) within Duke-NUS University. In 2021, Korea is in its early stages, starting to run a university's degree program related to regulatory science this year. Conclusion: Regulatory science should be developed with the aim of improving the regulatory ability of the Ministry of Food and Drug Safety with Korea's independent concept of regulatory science.

• 한국의학물리학회지:의학물리
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• 제23권1호
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• pp.26-32
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• 2012

확대촬영은 일반촬영뿐 아니라 미세골촬영, 유방촬영 및 다른 진단 영역에서 널리 사용되고 있다. 유한한 X선 초점의 크기로 인해 확대촬영은 분해능, 노이즈, 대조도 등 영상 시스템 전체에 영향을 미친다. 본 연구의 목적은 유효검출양자효율(effective detective quantum efficiency, eDQE)을 이용하여 영상시스템에 있어서 확대도와 초점크기의 영향을 알아보고자 함이다. 전체적인 영상 시스템 특성을 반영하는 eDQE는 초점에 의한 흐림 현상, 확대, 산란 그리고 격자 반응 등의 영향을 고려한다. 본 실험에서는 Food and Drug Administration (FDA)에서 고안된 흉부 팬텀을 사용하여 실제 가슴 촬영조건에서 측정된 유효변조전달함수(effective modulation transfer function, eMTF), 유효잡음력스펙트럼(effective noise power spectrum, eNPS), 산란율(scatter fraction, SF) 및 투과율(transmission fraction, TF)을 통해 eDQE 값을 도출하였다. 연구 결과를 통해 살펴보면 소초점을 사용했을 경우, eMTF의 값이 10%일 때의 공간주파수는 확대도가 1.2, 1.4, 1.6, 1.8, 2.0일때 각각 2.76, 2.21, 1.78, 1.49 그리고 1.26 lp/mm이었다. 대초점을 사용했을 경우, MTF의 값이 10%일 때의 공간주파수는 확대도가 1.2, 1.4, 1.6, 1.8, 2.0일 때 각각 2.21, 1.66, 1.25, 0.93 그리고 0.73 lp/mm이었다. 확대도가 증가할수록 eMTF 값이 떨어지고, 소초점을 사용했을 때가 대초점을 사용했을 때보다 eMTF가 전체적으로 높다는 것을 확인할 수 있었다. 초점의 크기에 따른 zero frequency에서의 eDQE 값의 변화는 크게 보이지 않았다. 그러나 대초점을 사용했을 경우, 소초점을 사용했을 때보다 저 주파수에서 고 주파수로 갈수록 eDQE가 급격하게 감소하는 것을 확인할 수 있었다. 일반적으로 확대촬영은 작은 병변을 확대시키고 낮은 유효잡음과 air-gap에 의한 산란선의 감소로 인해 대조도를 증가시킨다. 이로 인해 크기가 작은 병변을 고대조도로 확대시킴으로써 진단율을 높일 수 있다. 그러나 초점 크기로 인한 흐림 현상이 확대도에 따라 공간 분해능에 더 큰 영향을 미친다. 이러한 결과를 바탕으로, 디지털 일반촬영 시스템에서의 확대촬영을 시행하기 위한 적절한 초점크기와 확대도가 확립되어야 한다.