• 전자공학회논문지SC
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• 제48권5호
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• pp.74-80
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• 2011

본 연구는 유통되는 이식형(implantable) 의료기기의 추적(tracking) 및 회수(recall) 처리를 신속하고 정확하게 수행할 수 있는 통합 전산 관리시스템 설계하는 것을 목적으로 한다. 이를 위해 최신 FDA 규정을 만족하는 시스템을 MSF/CD 설계방법론을 기반으로 설계하였다. 추적과 회수의 주요한 4가지 가상 시나리오를 설정하고 workflow diagram을 작성하여 개념설계하였다. 또한 business workflow를 만족하는 서버의 논리 DB를 개발하여 논리설계 단계까지 시스템을 설계하였다. 제안된 시스템으로 이식형 의료기기의 심각한 부작용 등 문제 발생 시 신속하고 정확한 추적과 회수 처리가 가능하여 이식형 의료기기를 장착한 환자의 생명유지 및 국민 건강 보호를 위한 정부 차원의 효율적인 관리가 가능할 것으로 사료된다.

• 대한화장품학회지
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• 제29권2호
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• pp.79-104
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• 2003

Introducing to the market place, safe and effective product is an important responsibility of clinical investigators as well as regulatory agencies in all developed countries. Products claiming to improve skin wrinkles are no exceptions. To date, Renova(R) (all-trans retinoic acid), Avage(R) (tazarotene), and Botox(R) (botulinum toxin) are the only agents FDA approved to ameliorate wrinkles associated with photoaged skin in the USA. For all three, clinical evaluation of wrinkle severity was the primary endpoint required for the approval process. No sophisticated instrument measurements of wrinkles were required, nor used in the pivotal studies. The Division of Dermatologic & Dental Products of the US FDA (Director, Jonathan Wilkin, MD) is not against the use of mechanical instruments in assessing wrinkle severity. Its position on this issue however, remains that any such device must be grounded in patients' or product users' perspective, which means that the evaluation instrument must be clinically relevant and clinically perceptible. Sophisticated devices that can detect minimal improvement, but imperceptible to the users are considered useless in the eyes of the US FDA. Two instruments that have been tried in some antiwrinkle studies in the USA are silicone replicas and Primos. Despite their sophistications, they have clear limitations; thus have never replaced clinical evaluations in these studies. At most, they have served as secondary measures to provide corroborative data on the clinical efficacy of antiwrinkle products. For the foreseeable future, at least in the USA, careful clinical assessment of wrinkles will continue to serve as the critical benchmark to determine whether an antiwrinkle product has enough efficacy to benefit its users. We must not lose sight of the fact that sophisticated devices are only to serve in generating supportive evidence, and not the primary evidence, in any clinical studies.

• 대한임상검사과학회지
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• 제50권1호
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• pp.20-28
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• 2018

결핵(TB)은 Mycobacterium tuberculosis (MTB) 복합체의 구성원에 의한 세균 감염 질병이다. 결핵은 전 세계 인구의 1/3이 감염된 것으로 알려져 있으며, 한국에서는 매년 약 4만 명의 새로운 결핵환자가 발생한다. 또한, 비결핵 항상균 감염이 증가하고 있는 추세이다. 전통적인 결핵 및 비결핵 항상균 진단방법은 세균 배양으로 3~4주 이상이 소요된다. 따라서, 신속하고 정확한 결핵균(TB) 및 비결핵 항상균(NTM) 진단법의 필요성이 요구되고 있다. 결핵균 및 비결핵 항상균을 구분하기 위하여, 전 세계적으로 다양한 진단 방법이 개발되고 있다. 특히, 결핵균과 비결핵 항상균을 신속하고 정확한 동정의 요구가 증가함에 따라, 정확하고 신속하게 진단하기 위한 체외 진단 방법이 개발 되고 있다. 그러나 현재 결핵과 비결핵 항상균에 대한 체외 진단 시약의 성능 평가는 부족한 실정이다. 최근 식약청은 결핵균 및 비결핵 항상균 체외 진단 시약에 대한 가이드 라인을 발표했다. 본 연구에서는, 미국 FDA에 승인을 받은 결핵균 및 비결핵 항산균에 대한 체외 진단 시약의 성능을 검토하였다. 이 검토는 결핵균 및 비결핵 항상균 체외 진단 시약 평가에 유용한 참고 자료가 될것으로 사료된다.

• 한국식품영양학회:학술대회논문집
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• 한국식품영양학회 1998년도 학술심포지움 자료집
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• pp.91-102
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• 1998

이제 HACCP가 무엇이며 왜 이것을 단체 급식소에 적용해야 할 것인가의 것은 더 이상 논의 과제가 아니다. 문제는 어떻게 HACCP 원리를 주방 동선 구성에 적용할 것이며 동시에 이 원리 기준에 적합한 주방 기계 선정 및 운영 절차는 무엇인가에 관한 하드웨어적 접근에 관심이 모여지고 있다. 작은 정부를 주장하는 메리랜드 주에서는 미국에서 최초로 새로운 조리 시설을 짓거나 전반적 보수공사 하는 모든 외식업체는 HACCP Plan을 제출한 후 통과된 경우에 한하여 공사 허가서를 내어주고 있다. 이로써 업체 종사원 스스로가 위생 상태를 점검 기록함으로 함으로 식중독 사고를 사전에 예방함과 동시에 공무원의 업체 방문을 최소화 하여 적은 인원으로 효율적인 주 정부 운영을 하고 있는 것이다. 또한 자발적으로 많은 외식 업체들이 마케팅 차원에서 경쟁 업체와의 차별화 정책의 일환으로 스스로 서둘러 HACCP를 도입하고 있다. 워싱턴 DC지역에서는 요식협회 스스로 HACCP를 도입한 외식업소에 "Extra Step"이라는 로고를 사용케 하고 있다. 이로써 보다 많은 고객들이 이 로고를 보고 해당 식당을 선택토록 광고의 효과를 더 하기 위함이다. 당연히 이와 같은 추세에 따라 유럽과 미국의 세계적인 주방 기기 메이커들도 미국의 National Sanitation Foundation(NSF), US Dept of Agriculture(USDA) 및 FDA 의 규제 흐름에 따라 상당히 빠른 속도로 HACCP 원리에 적합한 기능을 기계적으로 보완해 가고 있다. 최근 4/15/98, FDA가 대량 급식소를 포함한 주방의 HACCP 적용매뉴얼을 인터넷 web 주소 http://vm.cfsan.fda.gov/~dms/ hret-1.htm 통하여 발표한 내용과 미 육군의 식당 위생 기술 자료 TB MED 530 자료, 그리고 87년 12월 이후 (주)HRS 에서 기계 설치 사후 관리하면서 경험한 사항을 중심으로 다음 내용을 정리해 보고자 한다.리해 보고자 한다.

• 한국동물위생학회지
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• 제33권4호
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• pp.393-399
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• 2010

We analyzed the HACCP prerequisite of National Veterinary Research and Quarantine Service (NVRQS) and the Food Establishment Inspection Report of US Food and Drug Administration (FDA) to recommend contents and ranges to be complemented and used for preparation of guidelines for more effective application of HACCP prerequisites. We used the HACCP inspection reports implemented by Korea Livestock Products HACCP Accreditation Service from 2007 to 2009, FDA Food Code 2009 Guide 3-B Instructions for Marking the Food Establishment Inspection Report, and Retail Food Establishment Sanitation Requirements of 410 Indiana Administrative Code. Major non-compliance items were open doors and windows, insanitary cleaning of in-use utensil, inadequate record of warehousing, and improper storage, transportation, and labelling. Hot water supply, personal hygiene, and regular product testing were additional week points which should be more strongly controlled by detailed operating guidelines. Also, current prerequisite items were required revision into more precise contents to enhanced the effective evaluation and practical application in meat markets.

• 전자통신동향분석
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• 제34권5호
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• pp.113-126
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• 2019

Based on the accumulation of medical big data, advances in medical artificial intelligence technology facilitate the timely treatment of disease through the reading the medical images and the increase of prediction speed and accuracy of diagnoses. In addition, these advances are expected to spark significant innovations in reducing medical costs and improving care quality. There are already approximately 40 FDA approved products in the US, and more than 10 products with K-FDA approval in Korea. Medical applications and services based on artificial intelligence are expected to spread rapidly in the future. Furthermore, the evolution of medical artificial intelligence technology is expanding the boundaries or limits of various related issues such as reference standards and specifications, ethical and clinical validation issues, and the harmonization of international regulatory systems.

• 한국임상약학회지
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• 제32권4호
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• pp.352-361
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• 2022

Objective: This study aimed to analyze the important medical adverse events (IMEs) of cyclosporine and tacrolimus using the reports in US FDA adverse event reporting system (FAERS) and to detect related signals. Methods: The FAERS database was used to analyze the IMEs reported for cyclosporine or tacrolimus during 2017-2021. Reporting odds ratio (ROR) and information component were used to analyze signals for adverse events of both drugs. It was investigated whether the detected signals were present on drug labels in Korea and the United States. Results: Among the total 24,688 reports, the reports on tacrolimus accounted 75.8%. Mean age of the patients was 47.9 years old and median number of adverse events was 2.0 per report. The number of patients hospitalized for adverse events was 7,979 (25.3%). Among the adverse reactions reported on the cyclosporine and tacrolimus, 576 and 1,363 events were detected as signals for cyclosporine and tacrolimus, respectively, and of these, IMEs accounted for 44.8 and 59.2%, respectively. The IMEs related with infections/infestations, renal/urinary disorders, and blood and lymphatic system disorders were reported frequently for both drugs. The most frequently detected IMEs were renal impairment for cyclosporine and acute kidney injury for tacrolimus. Among the top 3 IMEs for each reported SOC for cyclosporine and tacrolimus, 9 and 2 unexpected adverse events were identified, respectively. Conclusion: This study identified the IMEs and signals of cyclosporine and tacrolimus, and detected unidentified adverse events in a drug information database.

• 대한세포병리학회지
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• 제18권1호
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• pp.1-12
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• 2007

Approximately 70% of cervical cancers are caused by HPV types 16/18 and thus the implementation of vaccination programmes with vaccines against HPV types 16/18 will have a major impact on the incidence of cervical cancer worldwide. However, this reduction will not be seen until several decades after full implementation of such vaccination programmes since the vaccines must be given to young adolescents before exposure to the virus and women who are already sexually active are not likely to be protected. Both GSK and Merck insist that even vaccinated women must continue to participate in regular cervical screening by the most sensitive method available since the vaccine can only give protection against up to 70% of cervical cancers. It is unlikely that the current vaccines will be modified to include additional high risk HPV types in the foreseeable future. While HPV testing is highly sensitive, it is not recommended for women under 30 years of age nor for vaccinated women. Additionally, HPV testing has poor specificity. The Digene Hybrid Capture 2 test is licensed for use only in conjunction with a cytology test, not as a stand-alone test, and the high risk panel has recognised cross reactivity with low risk HPV types. None of the other HPV test methods currently commercially available are FDA approved and all must be internally validated before use. This makes comparison of test results between laboratories difficult. The most sensitive and specific screening test currently available for women of all ages is the Cytyc ThinPrep System consisting of the ThinPrep Pap Test (TPPT) and the ThinPrep Imaging System (Imager). The TPPT was the first LBC system approved by the US FDA in 1996 and there are about 4,000 processors in use worldwide. The Imager was FDA approved in 2003 and over 350 systems are in routine use, mainly in the US. 40% of TPPT in the US are processed on Imager. There is clear evidence in peer reviewed literature that the Imager increases laboratory productivity by 100% and growing evidence that Imager detects more high grade SIL than the conventional smear or manual evaluation of TPPT. This aspect is particularly important since the number of cytological abnormalities will decrease as vaccination programmes are implemented. Cytotechnologists will see fewer and fewer abnormal smears and their skills will be put at risk. By doubling throughput, Imager will allow cytotechnologists to maintain their skills.

• 한국데이터정보과학회:학술대회논문집
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• 한국데이터정보과학회 2006년도 추계 학술발표회 논문집
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• pp.43-48
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• 2006

In 2001 US FDA proposed a draft guidance for future in vivo bioequivalence studies. The guidance suggested specific criteria for new drug sponsors to show prescribability and switchability in bioequivalence testing for approval of generic drugs. However, there is less acceptance of the need to change statistical procedures and study designs from those currently used to assess the current criterion of average bioequivalence. The measures of population and individual bioequivalence testing are introduced and statistical procedures for them are discussed.

• Journal of the Korean Data and Information Science Society
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• 제18권3호
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• pp.645-657
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• 2007

Several statistical procedures for assessment of bioequivalence of variabilities between two drug formulations in bioequivalence trials are reviewed and modified methods for assessing total variability are suggested. The problem of the current US FDA aggregate criterion for population bioequivalence and the necessity of disaggregate criterion are discussed with an illustrated example.