• Food Science and Industry
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• v.40 no.1
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• pp.27-35
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• 2007

측정불확도란 시험결과에 대하여 측정량을 합리적으로 추정한 값들의 분산 특성을 나타내는 파라미터(parameter)로써 ILAC(국제시험소인정협력체) 등의 국제기구와의 측정결과에 대한상호인정 및 신뢰성 확보에 필수적인 요소이다. 국제표준(ISO/IEC 17025)에 맞는 시험분석 결과의 도출을 위해서는 먼저 소급성을 유지하고 그에 따른 불확도를 산출하여야 한다. 소급성은 실험의 모든 과정에 불확도를 가지고 끊기지 않는 비교연결을 통한 국제(국가)표준과 연관시키는 시스템으로, sampling에서 측정결과의 도출까지 소급성을 유지하는 것만이 측정결과의 신뢰성(정확 및 정밀)을 유지하는 최상의 시스템이다. Guide to the Expression of Uncertainty in Measurements(GUM)에 의한 불확도 계산 절차는 측정량(measurand)의 함수 표현, 입력량의 표준불확도(standard uncertainty)의 계산(표준편차, 평균의 표준편차), 합성표준불확도(combined uncertainty)의 계산, 확장불확도(expanded uncertainty)의 계산을 통한 통계적 추정을 하는 것이다. 오렌지 쥬스 중 카드뮴을 분석함에 있어서, 실험실에 대해서는 국제표준화(ISO17025) 시스템을 도입하고 분석시약 및 기기에 대하여 소급성을 유지하여, 분석결과의 신뢰성을 확보하기 위한 측정불확도를 산출하였다.

• Korean Journal of Clinical Pharmacy
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• v.21 no.2
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• pp.138-144
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• 2011

In order to minimize such adverse drug reactions, governments and international organs have been on the watch for them. Also in South Korea, a system has been established in order that adverse drug reactions may be reported to Korea Food and Drug Administration(KFDA). This study is to analyze drugs to cause adverse reactions, the adverse reactions and patients concerned on the authority of the data of Korea FDA, which is expected to be the preliminary data on preventable adverse reactions. This study was conducted on the 74,037 cases of adverse drug reactions reported to Korea FDA between January 2007 and June 2010. Fentanyl, iopromide and tramadol caused adverse reactions with high frequencies. Oseltamivir showed a high frequency between 2009 and 2010 due to the influence of the new influenza A. Also, OTC drugs accounted for approximately 5% of the adverse reactions. In 2009, adverse drug reactions remarkably increased (2,106 cases; 10.1%) in infants and children due to the new influenza-A(H1N1). The patients aged between 31 and 64 accounted for approximately 55% during the given period. There was no significant intergender difference. In relation to regions, the adverse reactions most frequently occurred in the gastrointestinal system and the integumentary system for three and half years. In addition to anticancer drugs and immunosuppressive drugs that are known to cause adverse reactions frequently, not a few of OTC drugs and external preparations caused such reactions. In particular, the drugs containing specific ingredients caused adverse reactions more frequently than others from 2007 until the first half of 2010. It is advisable for prescribers to acquaint themselves with such adverse reactions and to prescribe drugs other than them. They also have need to sensibly cope with adverse drug reactions just in case they have no substitute drugs. In addition, patients also need to be trained to understand possible adverse reactions in order that they can sensibly accommodate them or choose healthcare services. The results of this study are expected to be helpful to minimize adverse drug reactions.

• Korean Journal of Food Science and Technology
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• v.34 no.6
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• pp.1103-1109
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• 2002

Mean concentration and daily intake of sorbic acid were estimated through the analysis of food samples obtained from Korea FDA and food sanitation inspection agency during $1999{\sim}2000$. Total number of samples were 14,129, among which the number of detected samples were 2,561 (detection rate was 18.13%). Contribution rate to total estimated daily intake (%) of sorbic acid in the categorized food were the highest in processed fish product. Total estimated daily intake $({\Sigma}EDI)$ for age groups were the highest in $30{\sim}49$ years old and ranged from 3.42 to 9.25 mg/person/day. Estimation of average food intake for each food item per person per day was based on data in national nutrition survey and national food disapperance data in 1998. Total estimated daily intake of sorbic acid was 20.40 mg per body weight of 55 kg. This value was 1.48% of acceptable daily intake evaluated by FAO/WHO and 33.03% of theoretical maximum daily intake.

• Journal of Biomedical Engineering Research
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• v.31 no.2
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• pp.123-128
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• 2010

The thermometers is widely used in diagnostic medical devices, and the safety and accurate performance of these devices are important in the diagnosis and monitoring of personal health. Especially, the accuracy of infra-red thermometer is highly emphasized. Here two typical thermometers are utilized for this purpose: the electronic thermometers measure body temperature by contacting to subject while infra-red thermometers measure by no contacting to subject. Therefore, the evaluating items of each thermometer are different, and the standard for each temperature is highly needed. But, there have been no international standards of each thermometer such as IEC. In this paper, we developed the standards of electronic and infra-red thermometer based on national standards such as KS, ASTM, EN, JIS and FDA guidance. The new standards focused on the safety and suitable performance for health care. This standards were applied to enact and revise the electronic medical device standards. So it can be applied to evaluate the safety and performance on technical file review. We predict that this standard will improve the quality of diagnostic medical devices (thermometers) and increase the international competitive power of domestic product.

• The Korean Society of Law and Medicine
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• v.15 no.2
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• pp.63-89
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• 2014

In 1976, the Dalkon Shield-intrauterine device injured several thousand women in U.S.A. which caused the changes of medical deivce regulation. The Medical Device Regulation Act or Medical Device Amendments of 1976 (MDA) was introduce. As part of the process of regulating medical devices, the MDA divides medical devices into three categories. The class II, and III devices which have moderate harm or more can use the section 510 (k), premarket notification process if the manufacturer can establish that its device is "substantially equivalent" to a device that was marketed before 1976. In 21 U.S.C. ${\S}$ 360k(a), MDA introduced a provision which expressly preempts competing state laws or regulations. After that, the judicial debates had began over the proper interpretation and application of Section 360(k) In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that manufacturer approved by the Food and Drug Administration (FDA)'s pre-market approval process are preempted from liability, even when the devices have defective design or lack of labeling. But the Supreme Court ruled in Medtronic Inc. v. Lora Lohr that the manufactures which use the section 510 (k) process cannot be preempted and in Bausch v. Stryker Corp. that manufactures which violated the CGMP standard are also liable to the damage of patient at the state courts. In 2009, the Supreme Court ruled in Wyeth v. Levine that patients harmed by prescription drugs can claim damages in state courts. This may cause a double standard between prescription drugs and medical devices. FDA Preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding Food and Drug Administration approved products. FDA Preemption has been a highly contentious issue. In general, consumer groups are against it while the FDA and pharmaceutical manufacturers are in favor of it. This issues also influences the theory of product liability of U.S.A. Complete immunity preemption is an issue need to be more declared.

• Korean Journal of Veterinary Service
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• v.33 no.4
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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.

• Archives of Obesity and Metabolism
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• v.2 no.1
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• pp.17-24
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• 2023

Obesity is a major public health problem worldwide, with several methods having been proposed as a means of weight loss. If diet, exercise, and medication are insufficient, a healthcare professional may suggest weight loss treatments, including bariatric surgery or medical devices. Antiobesity medical devices are an option for patients who do not want to undergo bariatric surgery. Compared with bariatric surgery, medical devices have the advantage of being reversible and easier to operate. The U.S. Food and Drug Administration (FDA) regulates medical devices, including those used for weight loss and weight management. This article provides an overview of the FDA-regulated weight loss and weight management devices.

• BMB Reports
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• v.57 no.1
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• pp.50-59
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• 2024

The application of gene engineering in livestock is necessary for various reasons, such as increasing productivity and producing disease resistance and biomedicine models. Overall, gene engineering provides benefits to the agricultural and research aspects, and humans. In particular, productivity can be increased by producing livestock with enhanced growth and improved feed conversion efficiency. In addition, the application of the disease resistance models prevents the spread of infectious diseases, which reduces the need for treatment, such as the use of antibiotics; consequently, it promotes the overall health of the herd and reduces unexpected economic losses. The application of biomedicine could be a valuable tool for understanding specific livestock diseases and improving human welfare through the development and testing of new vaccines, research on human physiology, such as human metabolism or immune response, and research and development of xenotransplantation models. Gene engineering technology has been evolving, from random, time-consuming, and laborious methods to specific, time-saving, convenient, and stable methods. This paper reviews the overall trend of genetic engineering technologies development and their application for efficient production of genetically engineered livestock, and provides examples of technologies approved by the United States (US) Food and Drug Administration (FDA) for application in humans.

• Genomics & Informatics
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• v.12 no.4
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• pp.151-155
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• 2014

In November 2013, the US Food and Drug Administration (FDA) sent a warning letter to 23andMe, Inc. and ordered the company to discontinue marketing of the 23andMe Personal Genome Service (PGS) until it receives FDA marketing authorization for the device. The FDA considers the PGS as an unclassified medical device, which requires premarket approval or de novo classification. Opponents of the FDA's action expressed their concerns, saying that the FDA is overcautious and paternalistic, which violates consumers' rights and might stifle the consumer genomics field itself, and insisted that the agency should not restrict direct-to-consumer (DTC) genomic testing without empirical evidence of harm. Proponents support the agency's action as protection of consumers from potentially invalid and almost useless information. This action was also significant, since it reflected the FDA's attitude towards medical application of next-generation sequencing techniques. In this review, we followed up on the FDA-23andMe incident and evaluated the problems and prospects for DTC genetic testing.

• YAKHAK HOEJI
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• v.44 no.4
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• pp.308-314
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• 2000

Logarithmic transformation of pharmacokinetic parameters is routinely used in bioequivalence studies based on pharmacokinetic and statistical grounds by the United States Food and Drug Administration (FDA), European Committee for Proprietary Medicinal Products (CPMP), and Japanese National Institute of Health and Science (NIHS). Although it has not yet been recommended by the Korea Food and Drug Administration (KFDA), its use is becoming increasingly necessary in order to harmonize with international standards. In the present study, statistical procedures for the analysis of a bioequivalence based on the log transformation and a related SAS procedure were demonstrated in order to aid the understanding and application. The AUC parameters used in this demonstration were taken from the previous bioequivalence study for two aceclofenac tablets, which were performed in a single-dose crossover design. Analysis of variance (ANOVA), statistical power to detect 20% difference between the tablets, minimum detectable difference and confidence intervals were all assessed following log-transformation of the data. Bioequivalence of two aceclofenac tablets was then estimated based on the guideline of FDA. Considering the international effort for harmaonization of guidelines for bioequivalence tests, this approach may require a further evaluation for a future adaptation in the Korea Guidelines of Bioequivalence Tests (KGBT).