• 한국임상약학회지
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• 제28권2호
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• pp.146-153
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• 2018

Objective: Multi-regional clinical trials have been widely used for accelerating global drug development by multinational pharmaceutical companies. In this study, we aimed to review and analyze the international trends in regulations and guidelines on multi-regional clinical trials by regulatory authorities and international organizations, such as International Conference on Harmonisation, for referring to policies, including development of domestic guidelines for multi-regional clinical trials. Methods: The policies, regulations, and guidelines published by the US Food and Drug Administration, European Medicines Agency, Pharmaceuticals and Medical Devices Agency (Japan), and China Food and Drug Administration were searched, and the International Conference on Harmonisation E17 draft guideline was reviewed. Results: The regulatory authorities in developed countries have developed and implemented regulations and guidelines on multi-regional clinical trials to promote simultaneous global drug development and evaluate the regional differences in drug safety and efficacy. International Conference on Harmonisation developed the draft guideline for planning/designing of multi-regional clinical trials in 2016, which recommends the general principles for strategy-related issues and design of multi-regional clinical trials, and for protocol-related issues, such as consideration of regional variability, subject selection, dose selection, endpoints, comparators, overall sample size, allocation to regions, collecting information on efficacy and safety, and statistical analysis. Conclusion: It is important to understand the international regulatory requirements for designing and planning of multi-regional clinical trials for global drug development. Moreover, it is necessary to prepare multi-regional clinical trial guidelines in accordance with the Korean regulation for clinical trials and drug administration.

• Asian Pacific Journal of Cancer Prevention
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• 제17권11호
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• pp.4935-4937
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• 2016

Objective: To compare dosimetric parameters of 3 dimensional conformal radiotherapy (3 DCRT) and intensity modulated radiotherapy (IMRT) in terms of target coverage and doses to organs at risk (OAR) in the management of rectal carcinoma. Methods: In this prospective study, conducted between August 2014 and March 2016, all patients underwent CT simulation along with a bladder protocol and target contouring according to the Radiation Therapy Oncology Group (RTOG) guidelines. Two plans were made for each patient (3 DCRT and IMRT) for comparison of target coverage and OAR. Result: A total of 43 patients were recruited into this study. While there were no significant differences in mean Planning Target Volume (PTV) D95% and mean PTV D98% between 3 DCRT and IMRT, mean PTV D2% and mean PTV D50% were significantly higher in 3 DCRT plans. Compared to IMRT, 3 DCRT resulted in significantly higher volumes of hot spots, lower volumes of cold spots, and higher doses to the entire OAR. Conclusion: This study demonstrated that IMRT achieves superior normal tissue avoidance (bladder and bowel) compared to 3 DCRT, with comparable target dose coverage.

• 한국의학물리학회지:의학물리
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• 제2권1호
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• pp.29-35
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• 1991

다양한 의료용 선형가속기의 출현으로 인한 방사선 치료분야의 폭넓은 활용에 따라 정확한 선량측정이 중요한 문제중의 하나가 되어왔다. 따라서 정확한 선량계산이나 새로운 선량계산 모델을 위해서 X-선의 조사면에 따른 에너지 분포에 대한 연구가 필요하다. 본 연구에서는 의료용 선형가속기에서 발생된 X-선의 에너지 분포특성 및 기하학적 구조의 영향 요인 연구에 몬테-칼로 방법의 적용성을 자료분석에 의한 모의시험 계산값과 선량분포계산, 불에서 HVL 및 측정된 자료와 비교하여 알아 보았다. 기대한 것 처럼 X-선 빔의 축반경에 따른 평균에너지 변화로 부터 빔의 발생특성과 treatment head부분의 기하학적 구조 영향에 기인한 에너지 분포가 중심선 속으로 부터 멀어져 감에 따라 적어짐을 알 수 있었다.

• 대한핵의학회지
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• 제19권2호
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• pp.51-55
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• 1985

Prospective study of lymph node imaging of twenty stomach cancer cases with dissected lymph nodes being injected into the submucosa layer of stomach under surgical field was done. Total dose of 5 mci in 5 cc of volume was injected along the multiple sites of the lesser and greater curvature of stomach and collected lymph nodes within 2 hour of surgical time were placed under gamma camera and lymph node imagings were obtained. Pathological invasion of tumor and correlation of cold defect or hot uptake was compared each other. Tumor invasion of nodes revealed cold defect area which was correlated well with the pathological specimen. Correlation rate was 84.6%. We are planning to extend these procedures and trying endoscopic injection of positive imgaing agents such as Ga-73-3 Ig 2 alpha in future.

• Food Science and Biotechnology
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• 제18권2호
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• pp.533-536
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• 2009

Withdrawal time of erythromycin in the cultured black rockfish (Sebastes schlegeli) was investigated to provide regulatory authority and fishery industry with full information needed to secure food safety of the fish treated with erythromycin. Medication was carried out using the experimental diet containing erythromycin of which concentration was 200 mg/kg diet and its daily dose was about 40 mg/kg body weight. The withdrawal time needed to reduce antibiotic contents around 10.0 mg/kg accumulated during 9 days medication below 0.2 mg/kg was identified about 10 days. The antibiotic with 13.7 mg/kg of fish on the $9^{th}$ days of medication was completely depleted after 30 days from stop of medication.

• 전자공학회논문지
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• 제51권12호
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• pp.111-122
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• 2014

방사선요법이 암의 치료에 널리 사용되는 방법 중의 하나가 되면서 호흡에 의한 환자 움직임의 정확한 추적은 치료 계획이나 조사량 계산에 있어 매우 중요한 요소가 되고 있다. 호흡에 의한 움직임의 부정확한 추적은 일반 조직의 오류나 높은 준위의 방사선에 노출되는 건강한 조직의 범위를 확대시키는 심각한 논란을 야기할 수 있다. 다양한 호흡 예측에 대한 기술이 연구가 되었지만, 대부분의 기술들은 특정 전자장치나 고가의 부품을 필요로 하였다. 본 논문에서는 기존의 기술에 비하여 저가이고 사용이 간편한 대안으로서 스테레오 비전 기술을 이용하여 시각 코드 타겟을 추출하고 복호화하여 새로운 3차원 호흡 추적 방법을 제안한다.

• 한국치위생학회지
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• 제18권4호
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• pp.423-432
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• 2018

Objectives: Calcium hydroxide, a root canal temporary sealer, has long been used and it has anti-bacterial and anti-inflammatory activity. To investigate the properties of a newly developed calcium hydroxide paste comprising silicon-substituted hydroxyapatite (Si-HA), we examined the anti-inflammatory activity of the new calcium hydroxide paste in RAW 264.7 macrophages stimulated by lipopolysaccharide (LPS), which causes infection of the root canal. Methods: The test materials, including Calcipex II as control group and the newly developed TRC paste, were extracted from cell culture media and then diluted for experiment. In LPS-stimulated RAW 264.7 cells, the cytotoxicity and nitric oxide (NO) production of test materials were measured by MTT assay and Griess reagents, respectively. Also, the expression of the inducible nitric oxide synthase (iNOS) was assessed by western blotting. Results: The IC50 values of Calcipex II and TRC paste were $17.6mg/m{\ell}$ and $13.5mg/m{\ell}$, respectively. The level of NO, increased by LPS, was dose-dependently inhibited more by TRC paste than Calcipex II treatment. In addition, iNOS expression was decreased by 71% and 92% at concentrations of $2mg/m{\ell}$ and $20mg/m{\ell}$ of TRC paste, respectively. Conclusions: We demonstrated that the Si-HA calcium hydroxide paste has a slightly improved anti-inflammatory property and further studies are needed before clinical recommendations are proposed.

• 대한방사선기술학회지:방사선기술과학
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• 제36권2호
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• pp.157-163
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• 2013

2차원 방향으로 납을 이동하여 방사선 세기를 조절하는 기존의 다엽콜리메이터와는 다른 방식으로 고안 된 3차원 콜리메이터를 개발하였다. 3차원 콜리메이터는 복잡한 기하학적 구조에 방사선 조사에 있어 실시간으로 선량을 변화 할 수 있다. 3차원 콜리메이터는 정육면체 구조로 이를 구성하는 각각의 복셀화된 콜리메이터는 모터와 납으로 연결되어 있다. 각각의 프레임은 컴퓨터로 코딩된 FPGA 신호를 회로에 전달하여 계획대로 개별적으로 움직일 수 있다. 여러 가지 복잡한 기하학적 구조를 몬테칼로 시뮬레이션을 이용하여 결과를 도출하고 직접 실험한 결과를 비교 분석 하였다.

• ETRI Journal
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• 제42권6호
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• pp.837-845
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• 2020

The objective of this study was to implement an in vitro exposure system for 28 GHz to investigate the biological effects of fifth-generation (5G) communication. A signal source of 28 GHz for 5G millimeter-wave (MMW) deployment was developed, followed by a variable attenuator for antenna input power control. A power amplifier was also customized to ensure a maximum output power of 10 W for high-power 28-GHz exposure. A 3-dB uniformity over the 80 mm × 80 mm area that corresponds to four Petri dishes of three-dimensional cell cultures can be obtained using a customized choke-ring-type antenna. An infrared camera is employed for temperature regulation during exposure by adjusting the airflow cooling rate via real-time feedback to the incubator. The reported measurement results confirm that the input power control, uniformity, and temperature regulation for 28-GHz exposure were successfully accomplished, indicating the possibility of a wide application of the implemented in vitro exposure system in the fields of various MMW dose-response studies.

• Journal of Radiation Protection and Research
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• 제46권2호
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• pp.80-82
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• 2021

Dr. Haruyuki Ogino, a member of the Japan Health Physics Society (JHPS), was awarded the 2021 Bo Lindell Medal by the International Commission on Radiological Protection (ICRP). To commemorate this, the "Joint JHPS-KARP-ARPS program for young radiation protection (RP) scientists to discuss the future of RP" was organized via a web meeting system. First, Dr. Ogino gave a lecture, and then young researchers selected from each academic society made presentations on the future of RP. After the presentations by the three researchers, a free talk was held-young researcher groups of each country being active is a great opportunity to collaborate and exchange information. It was emphasized that the low awareness of knowledge related to radiation has been common to all of the participating countries. Thus, it is necessary to utilize communication via web technology, as done for this program, effectively. One of the biggest advantages for Asia and Oceania is that we do not have a significant time difference. The round-table discussion was concluded by expressing the hope of active exchange and development of young researchers in the future.