• The Optical Journal
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• s.144
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• pp.25-25
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• 2013

뷰웍스(대표 김후식)가 국내 기업으로는 처음으로 무선 평판 엑스레이 디텍터 제품의 미국 식품의약국(FDA) 승인을 획득했다. 엑스레이 디텍터는 투사된 엑스레이 영상을 디지털 정보로 바꿔주는 장치다.

• The Science & Technology
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• v.33 no.2 s.369
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• pp.18-19
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• 2000

포항공대 성영철 교수는 최근 에이즈의 DNA백신을 개발, 원숭이에서 방어면역이 발생함을 증명해내 에이즈 완치에 청신호가 되고 있다. 세계 최초로 개발에 성공한 이 이에즈 DNA백신은 미국 식품의약국(FDA)에서도 안전하다고 인정하고 있는 순수 DNA만으로 제조된 것이어서 사람에 대한 임상실험이 신속히 이루어질 수 있는 것이다. 이번 연구결과는 이미 특허출원했으며 소동물(생쥐) 실험결과는 백신분야의 세계적 권위지 "vaccine"지에 발표되었다.

• Bulletin of Food Technology
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• v.12 no.4
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• pp.36-44
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• 1999

기존의 미국 식품의약국(FDA, Food and Drug Administration)규정에 따르면 어떤 식품첨가물의 기능과 안정성을 평가하는 방법은 그때 그때 각각의 경우에 맞게 설정하여 실시하게 되어 있다. 이런 평가 방법은 포괄적이기는 하지만 과잉의 기능과 안정성 시험을 실시하는 결과를 초래해 왔다. 여기서는 새로운 식품 첨가물에 대한 안정성 시험 시 그 첨가물이 사용되는 실제 조건 하에서 체계적이고 과학적인 접근 방법에 따라 시험이 되도록 할 것을 제안하고자 한다. 체계적인 방법으로 시험하기 위해서는 새로 개발된 식품첨가물들이 사용하게 될 적용 대상 식품의 여러가지조건(pH, 수분, 가공 및 저장 온도)에서 그 첨가물의 안정성에 영향을 미치는 화학적, 물리적 주요 요인들이 먼저 결정되어야 한다. 그 다음 기능성과 안전성에 관련된 요소들이 하나의 모델 시스템으로 조직화되어 주요요인들의 측정 범위가 정해져야 한다. 마지막으로 설정된 모델 시스템은 첨가물이 실제 적용받게 되는 가공,운송, 저장 조건 하에서의 사용 조건을 고려한 상태에서 첨가물을 시험하여 기능과 안정성이 입증되어야 한다. 일단 증명이 되면 그 모델 시스템은 사용 가능성이 있는 적용 범위에까지도 그 첨가물의 기능성과 안정성을 평가할 수 있게 해준다. 이 논문에서는 식품첨가물 시험방법에 대한 체계적인 접근 방법을 설명하고 아스파탐의 예를 들어서 그 방법을 조명해 보고자 한다.

• Proceedings of the Korean Information Science Society Conference
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• 2006.10c
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• pp.535-539
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• 2006

미래 U-city 시대의 Health care 산업과 금융상거래 보안 및 사회안전 인증 장치로써 활성화 방안인 생체 칩은 2004년 10월 미 식품의약국(FDA)의 승인으로 더 큰 힘을 얻었다. 산업 전반적인 부분에 응용 가능한 생체 칩은 RFID 기술을 핵심기술로 사용하고 있으며, U-city 시대의 혁신적인 기술인 반면 개인정보 침해 및 법제도적, 윤리적, 전자파 유해성 이라는 문제점을 안고있다. 이 모든 문제점은 RFID 자체적인 문제점으로 많이 언급되어져 왔지만 생체 칩은 인체에 직접 사용한다는 점에서 더 큰 의미를 둔다. 현재 기술의 도입 시점인 생체 칩의 규제는 미국을 중심으로 가이드라인을 진행 중 이며, 우리 나라에서도 우려의 목소리가 높다. 본 연구는 사회적 인식이 부족한 생체 칩 기술 도입 전 미리 정보 보호 측면에서의 문제점을 분석하고 개선방향을 검토해 보고자 한다.

• Journal of the korean academy of Pediatric Dentistry
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• v.45 no.3
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• pp.393-399
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• 2018

The aim of this review is to introduce about the issue of benzocaine and methemoglobinemia. Through blocking the pain during dental treatment, fear and anxiety of patients will be reduced. Thus, anesthetic agent containing benzocaine is commonly used while controlling the pain of patients during treatment. However, on May 28, 2018, the Ministry of Food and Drug Safety reported a medication safety report about restricting the use of benzocaine-containing agents in infants under 24 months and children. Also, they recommended a cautious use to adolescents and adults to prevent methemoglobinemia (MHb). This report was published due to an advice from Food and Drug Administration (FDA) on May 23, 2018. When using agents containing benzocaine, dentists must consider the probability of MHb and prepare for early diagnosis and appropriate action. Since 1930s, methylene blue is known to cure MHb patients. Therefore, the proper use of methylene blue for emergencies and diagnosis methods for early diagnosis of MHb should be familiar to dentists planning for the use of topical anesthetic agents. Dentists should be trained for emergency situation of MHb caused by the use of benzocaine.

• 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.

• Journal of Applied Biological Chemistry
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• v.61 no.2
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• pp.195-204
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• 2018

Pesticide residue in the eggs in the market has become a significant problem in Korea. In particular, the detection of fipronil indicated that unregulated pesticide residue can be present in livestock products, including eggs. Institutionally unregulated pesticides are a risk to human health and the ecosystem. In this study, we analyzed the system of agricultural pesticide management in Korea, the European Union, and the United States of America (USA) and discussed the problems of the Korean management system and the possible improvement directions. Based on the analysis, we considered three tasks: registration of pesticides, pesticide residue levels in food, and pesticide residue levels in environmental media. The registration of pesticides was conducted by the Ministry of Agriculture, Food, and Rural Affairs in Korea; the Directorate-General for Health and Food Safety in the European Commission (EC); and the US Environmental Protection Agency (USEPA) in the USA. The work regarding pesticide residue levels in food was conducted by the Ministry of Food and Drug Safety in Korea, the Directorate-General for the Health and Food Safety in the EC, and the USEPA and Food and Drug Administration in the USA. The work regarding pesticide residue levels in environmental media was conducted by the Ministry of Environment in Korea, the Directorate-General for Environment in the EC, and the USEPA in the USA. Therefore, Korea should review the extension of pesticide residue standards in the environmental media for strengthening the system of management of unregulated agricultural pesticides.

• Korean Journal of Clinical Pharmacy
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• v.25 no.3
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• pp.171-177
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• 2015

Background: Androgenetic alopecia (AGA), one of alopecias, requires continuous treatment in order to prevent or stop it, and patient's compliance is very important. Currently, only two drugs (finasteride, minoxidil) have been approved for AGA by Food and Drug Administration of United States (US FDA). However, another ${\alpha}-2$ reductase inhibitor, dutasteride, is approved by Korea Ministry of Food and Drug Safety (MFDS) through a phase III trial. For treatment, pharmacotherapy of AGA usually combines topical minoxidil 7% with one of oral <${\alpha}-2$ reductase inhibitor. Objectives: We evaluated the comparative efficacy and adverse effect between topical minoxidil 7%/finasteride 1 mg and topical minoxidil 7%/dutasteride 0.5 mg pharmacotherapy for outpatients with AGA. Also we evaluated the relationship between therapeutic effect and regular hospital visit. Method: This study was performed retrospectively based on electronic medical record (EMR) data of total 98 patients (topical minoxidil 7% with dutasteride 0.5 mg ($Avodart^{(R)}$) or finasteride 1 mg ($Alopecia^{(R)}$, $Propecia^{(R)}$) with diagnosis of AGA from department of dermatology at a secondary hospital from January $1^{st}$, to May $31^{st}$, 2014. Results: The efficacy and adverse event of topical minoxidil 7%/dutasteride 0.5 mg (DUTA group) were 100% and 45.7%, and of topical minoxidil 7%/finasteride 1 mg (FINA group) were 92.1% and 33.3%, respectively. The mean onset time of responses and adverse events in the FINA group were 3.86 months and 4.43 months. Those in the DUTA group were 3.97 months and 5.06 months. Conclusion: Both FINA and DUTA group were highly effective, but the DUTA group showed higher efficacy and adverse effects than those in the FINA group. Dutasteride may be another alternative in AGA treatment.

• Journal of Dairy Science and Biotechnology
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• v.38 no.2
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• pp.70-88
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• 2020

Lactic acid bacteria (LAB) form an essential part of the intestinal microbiota of the human body and possess the ability to stabilize the intestinal microbiota, strengthen immunity, and promote digestion as well as intestinal synthesis of vitamins, amino acids, and proteins. Hence, LAB are currently widely used in various products. However, due to the indiscriminate overuse of antibiotics in humans and livestock, bacterial resistance to antibiotics has been increasing rapidly, which has led to serious problems in the treatment of bacterial infections. Additionally, several reports have revealed that antibiotic-resistant LAB may infect people whose immune systems are not fully developed or whose immune systems are temporarily weakened. Therefore, it is imperative to consider the possibility of antibiotic-resistant LAB causing diseases in humans and animals, investigate the mechanism of action between antibiotics and LAB, and determine the relevant regulations for the safe use of LAB.

• Korea Trade Review
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• v.48 no.3
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• pp.131-150
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• 2023

The purpose of this study was to find a countermeasure to the U.S. import refusals for the Korean healthcare and life sciences industry. To this end, an analysis of trends during the pandemic was conducted using the KITA Border Rejection Database, which includes information on items and types of import refusals. The reason for rejection was also analyzed according to the FDA violation codes. The degree of countermeasure for import refusals was identified by measuring the unit rejection rate (URR). The results of the analysis showed that the major U.S. import refusals for the Korean healthcare and life sciences industry had expanded from contact lenses to COVID-19 diagnostic kits and drugs after the pandemic broke out. The major reasons for import refusals were non-compliance with the Predicate Device and Drugs Act and non-approval by the FDA for products and facilities. On the other hand, the unit rejection rate (URR) of major items in the Korean healthcare and life sciences industry was measured higher than the industry average. The results therefore showed a low level of response to U.S. import refusals. The results of the analysis of reasons for import refusals by item according to FDA violation codes were as follows. First of all, the main violation for contact lenses and COVID-19 diagnostic kits corresponded to misbranding. This was often due to the fact that Korean companies did not provide the relevant notices and information required by the FDA. Many cases also failed to demonstrate a substantial equivalency compared to predicate devices already on the market. On the other hand, applications for new unapproved drugs were not accepted as they had yet to pass relevant regulations that would prove their safety and efficacy. In conclusion, import refusals for the Korean healthcare and life sciences industry were found to be closely related to technical barriers to trade (TBT).