• Journal of the Korean Data and Information Science Society
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• 제19권4호
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• pp.1211-1218
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• 2008

Maximum likelihood estimator (MLE) and restricted maximum likelihood estimator (REMLE) approaches are available in analyzing the linear mixed model (LMM) like bioequivalence trials. US FDA (2001) guides that REMLE may be useful to assess bioequivalence (BE) test. This paper studies the statistical behaviors of the methods in assessing BE tests when some of observations are missing at random. The simulation results show that the REMLE maintains the given nominal level well and the MLE gives a bit higher power. Considering the levels and the powers, the REMLE approach is recommended when the sample sizes are small to moderate and the MLE approach should be used when the sample size is greater than 30.

• 한국건축시공학회:학술대회논문집
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• 한국건축시공학회 2014년도 추계 학술논문 발표대회
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• pp.148-149
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• 2014

The aim of this research is to contribute on investment of less cement mortar or concrete in normal strength range using additional hydration of BS with stimulating effect of FGD and OPC based on the previous research result of the BS and RFA using cement mortar. As a test, the composition for normal strength range of mortar was evaluated with 0, 10, and 20 % of FDA and 0, 20 % of OPC replacement.

• 핵의학기술
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• 제12권1호
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• pp.74-77
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• 2008

The radiopharmaceuticals are routinely injected to blood vessel for acquiring PET image. For this reason, It is imperative that they undergo strict quality control measures. Especially, Sterility test is more important than any other quality control procedures. According to the FDA guideline, It requires filter integrity test used in the processing of sterile solutions. Among several methods, we can decide to use bubble point test. We usually use vented GS-filters (Millipore co., USA) which are sterilizinggrade (0.22 um pore size) and are placed upper site on product vial. After the synthesis of $^{18}F$-FDG, solutions wet the membrane in filter and then go into the product vial. By all synthesis steps have finished, we can observe the presence of the bubbles in the product vial. Since we have started this study, we have never found any bubbles in the product vial. Because the maximum pressure intensity of the filter which has set by manufacturer is up to 5 bars, but helium gas pressure is up to 1 bar in our module system. So, we can make 5 bars pressure using helium gas bombe and increase pressure up to 5 bars step by step. However, it does not happen to anything in vial.

• 대한한의학방제학회지
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• 제15권2호
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• pp.119-126
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• 2007

Objectives: This study presents observation of microorganism such as total aerobic bacteria, total fungus, E. coli, Pseudonomas aerugjnosa, Staphylococcus aureus, and Salmonella typhimurium in herbal decoction manufactured by Korean medical clinic. Methods: We examined to observe microorganism using the requirements for the experimental methods recommended by FDA. For the identification, we observed microscopic methods and carried out polymerase chain reaction (PCR) and DNA purification. The purified DNA samples were analyzed by DNA sequencer. As compared with NCBI database. the results were identified by sequences similarity. Results and conclusion: 26 (55%) of 46 decoctions observed positive for microbial test. 12 (46 %) of 26 positive decoctions exceed requirement of microbial limit test. These microbial colony identified genus of Bacillus using microscopic and DNA sequencing methods.

• 대한의용생체공학회:의공학회지
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• 제41권1호
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• pp.14-21
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• 2020

Recently, porous additive manufactured(AM) cages have been introduced to provide more desirable stiffness and may be beneficial to bone ingrowth. They are designed to attempt to reduce the subsidence problem of traditional titanium cage and to get osseointegrative property that PEEK doesn't have. This study was performed to evaluate the mechanical performance of newly developed lumbar porous AM cages. Three types of mechanical tests were performed in accordance with the ASTM standards: Static compression, compression-shear, and subsidence tests. The porous AM cages with 60% porosity showed similar device stiffness and strength as the various products submitted to FDA 510(k), and their wider contact area improved the subsidence test results by about 50%. In conclusion, the porous AM cages developed in this study were considered mechanically safe and could be an alternative to solid PEEK cages.

• 대한화장품학회지
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• 제49권4호
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• pp.349-354
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• 2023

자외선 차단제는 자외선을 차단 및 산란시켜 자외선으로부터 보호하는 제품으로 이제 화장품을 넘어서 생활필수품으로 자리 잡고 있다. 자외선 차단제 바르기는 일반적이면서도 손쉬운 자외선에 의한 피부 손상 예방법이다. 이러한 중요성에 따라 자외선 차단제 평가시험은 1978 년 Fod and Drug Administration (FDA)에서 규정을 마련한 이후, 현재는 International Organization For Standardization (ISO)에서 표준화된 방법까지 발전되었다. 더불어 물이나 땀 등 신체활동에 의한 자외선 차단제 손실을 평가하기 위해 국내 식약처와 ISO에서 내수성 자외선 차단지수 평가시험을 제정하고 있다. 그러나 지금까지의 내수성 자외선 차단지수 평가시험은 주로 일반 물을 사용한 시험 방법에 국한되어 있으며, 해변에서의 레저, 스포츠 및 여가활동에 의한 해수의 영향을 고려한 시험 방법은 아직 정립되지 않았다. 본 연구는 기존의 내수성 자외선 차단지수 평가시험 방법 가이드라인을 기반으로 일반 물, 인공 해수(소금물) 및 자연 해수(바닷물)에서의 내수성 자외선 차단지수를 비교하여 해양 레저, 스포츠 및 여가활동 등과 같은 실제 상황에서의 자외선 차단지수를 평가할 수 있는 방법에 대하여 조사하였다. 이러한 결과를 통해 일반 물과 인공 해수 및 자연 해수에서의 내수성 자외선 차단지수 평가시험의 차이를 비교하여 자연 해수를 이용한 내수성 자외선 차단지수 평가시험 방법을 제시할 수 있었다.

• Journal of Pharmaceutical Investigation
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• 제35권6호
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• pp.471-481
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• 2005

In Korea, generic drug and bioequivalence test are the hot issues since a new medical system of separation of dispensary from medical practice was started in 2000. The KFDA(Korea FDA) had revised several times ${\ulcorner}Guidance\;for\;bioequivalence\;test{\lrcorner}$. In vitro dissolution test has been extensively used as a quality control tool for solid oral dosage forms. In an effort to minimize unnecessary human testing, in vitro/in vivo correlations (IVIVC) between in vitro dissolution and in vivo bioavailability are increasingly becoming an integral part on extended release drug product development. The recently published US guidance, ${\ulcorner}Extended\;release\;oral\;dosage\;forms\;:\;development,\;evaluation,\;and\;application\;of\;in\;vitro/in\;vivo\;correlations{\lrcorner}$ will be helpful for us to make our own guideline.

• 대한의용생체공학회:의공학회지
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• 제41권5호
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• pp.210-218
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• 2020

Vessel sealing is a medical device that converts electrical or ultrasonic energy into thermal energy and leads to seal, coagulate, and cut the vessel by protein modification within the walls or surrounding connective tissues. As most of surgeries have recently been conducted with minimally invasive surgery, the demand and market for vessel sealing are expected to get bigger. However, there is a problem that electrosurgical or ultrasonic surgical is applied and we have a high risk to evaluate the strength of seal, because the collateral and particular standards currently in force follows have not been establish. Therefore, in this study, we investigated some papers studied on the efficacy and safety of the device, the guidance of FDA and test papers previously conducted from 3 individual subject device made in Korea. We found there is a relationship between burst pressure and the performance of the device, therefore, we propose the vascular bursting pressure test for evaluating the safety and performance of the vessel sealing.

• 한국지반공학회논문집
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• 제24권4호
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• pp.57-66
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• 2008

본 연구에서는 쪼갬 인장시험과 Fang, H. Y. and Fernandez(1981)에 의해 고안된 일축관입시험을 통한 동결토의 인장강도를 살펴보았다. 본 연구는 영하 15도의 환경 속에서 화강풍화토, 표준사와 카오리가 혼합된 사질 혼합토의 일축관입인장강도와 쪼갬 인장강도가 어떻게 변화하는지를 고찰하였다. 동결공시체는 함수비, 점토함량에 따라 다양하게 실험을 실시하였으며, 함수비와 점토함유량에 따라 일축관입인장강도와 쪼갬 인장강도간의 상호관계를 분석하였다. 결과를 요약하면, 평균적으로 쪼갬 인장강도는 일축관입인장강도에 비해서 4배정도 큰 강도를 나타내었다. 함수비가 증가함에 따라 두 인장강도간의 차이가 크게 나타났으며, 그리고 점토함량이 증가할수록 두 인장강도는 모두 감소하는 경향을 나타내었다.

• 한국가축번식학회지
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• 제19권2호
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• pp.135-140
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• 1995

The study was conducted to investigate on the survival rate of bisected porcine embryos co-cultured in 10% FCS(v/v)＋TCM-199 media containing hormones, oviductal epithelial cells and cumulus cells 0 to 72 hrs after bisection. In vitro survival rate was defined as development rate on in vitro culture or FDA-test. The results are summarized as follows ; 1. The survival rate of bisected porcine embryos cultrued in 10% FCS＋TCM-199 media contaning PMSG, hCG, PMSG＋hCG, hCG＋$\beta$-estradiol 0 to 20 hrs and 20 to 40 hrs were 37.6% and 37.5%, 28.6% and 28.6%, 35.7% and 28.8%, 30.8% and 23.1%, 38.5% and 30.7%, respectively. The survival rate of bisected embryos co-cultured in TCM-199 media containing hormones, oviductal epithelial cells and cumulus cells was significantly higher than that of non co-culture. 2. The survival rate of bisected porcine embryos co-cultured 10% FCS＋TCM-199 media containing oviductal epithelial cells 4 to 5 hrs and 20 to 24 hrs were 42.9% and 38.5%, respectively. 3. The survival rate of bisected porcine embryos co-cultured in 10% FCS＋TCM-199 media containing cumulus cells 4 to 5 hrs and 20 to 24 hrs were 40.0% and 35.7%, respectively.