• 약학회지
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• 제45권2호
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• pp.227-236
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• 2001

The complexity and variability of both the biologicals and the bioassays used to test them led to the use of the reference standard- a sample of the product of defined purity and potency, against which all preparations of that product must be calibrated. In order to prepare and establish KFDA reference standard for recombinant human growth hormone (somatropin), somatropin substance was filled in ampoules in National Institute for Biological Standards and Control (NIBSC). The candidate KFDA reference standard for somatropin (designated as 98/674) was evaluated to determine the suitability of serving as a KFDA reference standard for somatropin by the collaborative study, in which 10 laboratories participated. Physicochemical analysis and in vivo bioassay were performed by direct comparison with the international somatropin standard 88/624. 98/674 was identified as somatropin by SDS-PAGE, IEF, peptide mapping, and HPLC. Determination of somatropin content by SE-HPLC yielded a mean estimate of 2.01 mg somatropin per ampoule. Data from the study also yielded mean values of 0.39 $\pm$ 0.26% for high molecular weight impurities by SE-HPLC and mean values of 2.13 $\pm$ 1.29% for somatropin related proteins by RP-HPLC. Estimates of relative potency by weight gain bioassay in the hypophysectomised rats showed that relative potency of KS 98/674 was 1.07 aganist IS 88/624. Based on the results of the collaborative study, the candidate reference standard for somatropin is suitable to serve as a KFDA reference standard for somatropin.

• 한국물환경학회지
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• 제29권4호
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• pp.568-573
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• 2013

In this study, we conducted whole effluent toxicity (WET) proficiency testing based on the results which $EC_{50}$ value of 3 types (A, B, C) unknown samples calculated from 32 water quality measurement agencies in Korea. WET proficiency testing was expected to their improve of analysis skill and ensure reliability of analysis results. Ultimately, it is intended to promote the reliable enforcement of WET. WET proficiency testing was evaluated using the z-score, robust z-score and the results showed that 30 participating agencies were "compliance". In addition, $EC_{50}$ values of "unknown sample A" were the normal distribution. Therefore, "unknown sample A" was considered as the most suitable standard toxicity substance.

• 약학회지
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• 제59권3호
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• pp.98-106
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• 2015

Analytical method for related substances can be categorized into two methods depending on the necessity of reference standard (RS). The analytical method of related substances with RS is fast and accurate, but it's very expensive and technically difficult to synthesize RS due to their complicated structure. Another method is using relative retention time (RRT) and relative response factor (RRF) which are already validated with RS. Validation of this method is not easy and time consuming, but once it has been developed, it can save cost and time. In this study, we developed the analytical method for related substances of fenofibrate using RRT and RRF. We validated the method by evaluating specificity, linearity, accuracy and precision according to the "Manual for Guideline Application for Validation of Analytical Procedures" of MFDS. Also, we calculated RRT and RRF between fenofibrate and fenofibrate related substances. The results of this study showed high specificity for fenofibrate and fenofibrate related substances. Correlation coefficient(r) of all substances were more than 0.99, and the recovery of fenofibrate, fenofibrate related substance I, II and III were 99.44%, 100.84%, 99.14% and 101.58%, respectively. Precision of fenofibrate and its related substances were ranged between RSD 0.29% and 0.93%. Quantification limits of fenofibrate, fenofibrate related substance I, II and III were determined to be $0.03{\mu}g/ml$, $0.05{\mu}g/ml$, $0.04{\mu}g/ml$ and $0.02{\mu}g/ml$, respectively by confirming signal to noise ratio of each chromatogram. The RRT for fenofibrate related substance I, II and III were determined to be 0.35, 0.41 and 1.34, respectively. Also, the RRF for fenofibrate related substance I, II and III were determined to be 1.28, 0.98 and 0.79, respectively. The developed method was applied to determine contents for fenofibrate related substances in commercial fenofibrate (active pharmaceutical ingredient). As a result, developed analytical methods of related substances will be used for revising the monograph of fenofibrate in Korean Pharmacopoeia revision and contribute quality control of drugs by improving cost and time consuming problem of RS.

• Environmental Engineering Research
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• 제21권2호
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• pp.140-144
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• 2016

Owing to the kinetic differences in ammonia oxidation among ammonia-oxidizing microorganisms (AOM), there is no standard set of kinetic values that can be used as a representative set for nitrifying wastewater treatment plant (WWTP) design. As a result, this study clarified a link between the half-saturation constants for ammonia oxidation (Ks) and the dominant ammonia-oxidizing bacterial (AOB) groups in sludge from full-scale WWTPs and laboratory-scale nitrifying reactors. Quantitative polymerase chain reaction analyses revealed that AOB affiliated with the Nitrosomonas oligotropha cluster were the dominant AOM groups in the sludge taken from the low-ammonia-level WWTPs, while AOB associate with the Nitrosomonas europaea cluster comprised the majority of AOM groups in the sludge taken from the high-ammonia-level WWTPs and nitrifying reactors. A respirometric assay demonstrated that the ammonia Ks values for the high-ammonia-level WWTPs and nitrifying reactors were higher than those of the low-ammonia-level plants. Using the Ks values of available AOM cultures as a reference, the Ks values of the analyzed sludge were mainly influenced by the dominant AOB species. These findings implied that.different sets of kinetic values may be required for WWTPs with different dominant AOM species for more accurate WWTP design and operations.

• 한국안전학회지
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• 제25권5호
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• pp.27-32
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• 2010

This study is to investigate and compare domestic hazardous toys with harmful substances with foreign toys so that we can find out management criteria for in cognitive infants. Actually, commercially used toys have been collected and tested to find out more effective management standard. it is tried to produce evaluation criteria of environmentally harmful substance but variety of product is needed for overcoming actual barrier due to lot of difficulty huge cost, time, objectiveness. Therefore, This study does not cover all the above. Establishment of evaluation criteria for product harmfulness made by Government or Local government should be continued to improve. Foreign reference material for toy product in Europe, USA, Japan have been investigated and domestic product have been collected and tested for containing heavy metals, formaldehyde, phthalate in the study. All the test have been made in accordance with KSM ISO 2124 to measure heavy metal transfer into body. Toy product used for the study have been purchased in the real market and some of them contains harmful elements with over standard. Post management system such as RAPEX to control periodically should be established for plastic toy with low quality product.

• 대한임상검사과학회지
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• 제38권3호
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• pp.184-188
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• 2006

The purpose of the recovery experiment in clinical chemistry is performed to estimate proportional systematic error. We must know all measurements have some error margin in measuring analytical performance. Proportional systematic error is the type of error whose magnitude increases as the concentration of analyte increases. This error is often caused by a substance in the sample matrix that reacts with the sought for analyte and therefore competes with the analytical reagent. Recovery experiments, therefore, are used rather selectively and do not have a high priority when another analytical method is available for comparison purposes. They may still be useful to help understand the nature of any bias revealed in the comparison of kit experiments. Recovery should be expressed as a percentage because the experimental objective is to estimate proportional systematic error, which is a percentage type of error. Good recovery is 100.0%. The difference between 100 and the observed recovery(in percent) is the proportional systematic error. We calculated the amount of analyte added by multiplying the concentration of the analyte added solution by the dilution factor(mL standard)/(mL standard + mL specimen) and took the difference between the sample with addition and the sample with dilution. When making judgments on method performance, the observed that the errors should be compared to the defined allowable error. The average recovery needs to be converted to proportional error(100%/Recovery) and then compared to an analytical quality requirement expressed in percent. The results of recovery experiments were total protein(101.4%), albumin(97.4%), total bilirubin(104%), alkaline phosphatase(89.1%), aspartate aminotransferase(102.8), alanine aminotransferase(103.2), gamma glutamyl transpeptidase(97.6%), creatine kinase(105.4%), lactate dehydrogenase(95.9%), creatinine(103.1%), blood urea nitrogen(102.9%), uric acid(106.4%), total cholesterol(108.5), triglycerides(89.6%), glucose(93%), amylase(109.8), calcium(102.8), inorganic phosphorus(106.3%). We then compared the observed error to the amount of error allowable for the test. There were no items beyond the CLIA criterion for acceptable performance.

• 분석과학
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• 제16권2호
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• pp.134-142
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• 2003

LC-ICP-MS를 이용한 어류중 비소의 종분화 분석을 위해 microwave-assisted extraction과 sonication extraction 방법을 비교하였다. Ultrasonic nebulizer와 cross flow nebulizer를 사용한 비소종들의 검출한계는 유사한 결과를 보였다. 분석된 비소 종들은 arsenobetaine (AsB), arsenite [As(III)], dimethylarsine acid (DMA), monomethylarsonic acid (MMA), arsenate [As(v)] 와 phenylarsonic acid (PAA) 이다. 두 가지 방법은 NRCC (National Research Council of Canada)의 표준물질인 DORM-2를 50% 메탄올로 추출하였다. arsenobetaine의 경우, 두 방법 모두 5% 이하의 상대표준편차와 82% 이상의 추출효율을 보였다. Arsenobetaine은 microwave assisted extraction 방법에서 $14.18{\pm}0.42mg\;kg^{-1}$을 보였고 sonication extraction 방법에서는 $13.54 {\pm}0.84mg\;kg^{-1}$을 보였다. dimethylarsine acid (DMA)의 경우 각각 $0.45{\pm}0.06mg\;kg^{-1}$과 $0.44{\pm}0.06mg\;kg^{-1}$를 보였다.

• 핵의학기술
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• 제16권1호
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• pp.108-114
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• 2012

면역측정법을 이용하는 검사실에서 가장 많이 사용하고 있는 상업용 제3자 정도관리물질이 BIO-RAD사에서 제공하는 물질이다. 현재 BIO-RAD 정도관리 물질에 포함된 Reference Sheet에는 비방사면역측정을 이용한 검사방법과 검사장비별로 각 측정물질의 Acceptable Range가 기재되어 있다. 그러나 방사면역측정법을 이용하여 검사하는 측정kit나 기기에 대해서는 실무에 적용할 만한 Acceptable Range에 대한 언급이 다소 부족한 것이 현실이다. 방사면역측정검사에 대한 Acceptable Range를 설정하여 검사결과의 객관성을 높이고 누적된 데이터를 제조사에 권고하여 발행되는 Reference Sheet에 기재하고자 한다. 본원에서는 2009년부터 부분적으로 BIO-RAD 정도관리 물질을 사용하여 2011년에는 일부 특정 항목을 제외한 대부분의 검사종목에 BIO-RAD 제 3자 정도관리물질을 사용하고 있다. 따라서 측정된 내부정도관리 데이터를 BIO-RAD사의 Unity Real Time program (version 1.0.9.27)을 이용하여 Acceptable Range를 설정하였다. BIO-RAD 정도관리 물질을 사용하는 약 50가지 검사종목의 20개 Point Data의 평균값, 표준편차, 변이계수를 구하여 측정kit별 Acceptable Range를 산출하였으며, 자동화 면역 측정기기인 Roche Elecsys/ E170/ cobas e Systems의 측정값과 비교하였다. 현재 시행하고 있는 외부정도관리 프로그램과 같이 BIO-RAD 정도관리 물질을 공통으로 사용하는 병원과 peer group을 설정하여 측정 kit별, 기기별 Acceptable Range를 제조사에 권고하여 Reference Sheet에 방사면역검사실에 적합한 Acceptable Range를 기재하여 검사결과의 객관성을 높이고 국내외적으로 방사면역측정법에 대한 인지도를 높이고자 한다.

• 핵의학기술
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• 제16권2호
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• pp.139-148
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• 2012

이 실험은 검사를 매일 실행하고, 동결건조된 표준액을 매번 녹여서 사용하는 검사실은 그 안정성에 대하여 고민을 할 필요는 없지만, 검사를 일주일에 한번 또는 두 번 정도 실행하는 검사실에 대한 보고라고 할 수도 있다. 동결 건조한 표준물질은 용해한 후 다시 동결을 할 경우 보통 $-20^{\circ}C$이하에서 유효기간까지 보관하라는 식으로만 표현 되어져 있고, 이는 몇 번을 녹인 후 재사용해도 안정한가에 대해서는 표현된 바가 없기에 이번 실험은 동결건조한 표준용액을 녹임과 동결을 여러 번 번복하였을 때와 냉장보관을 하였을 시에 표준용액의 변화도와 이것이 결과에 미치는 영향을 비교 평가하였다. 시판되고 있는 방사면역측정법을 이용한 체외진단키트 중 동결건조표준용액으로 되어진 부갑상선호르몬(PTH), 부신피지자극호르몬(ACTH), 황체형성호르몬(LH) kit를 같은Lot.NO.로 구성하였다. 이를 D.W.로 각 용량에 맞게 용해한 후 3개의 대조군으로 분리하였다. 제1대조군은 녹임, 동결을 번복하는 방법으로 하였고 제2대조군은 용해한 후 Test tube에 1회 사용할 만큼 분주하여 동결을 하였고 제3대조군은 냉장보관으로 하였다. 표준액과 환자농도값 날짜 별로 비교하였고, pH Test를 하였으며 날짜 별 단순회귀분석 및 결정계수 산출을 하였으며 Excel Paired t-Test (p-value)를 하여서 유의수준관계를 분석하였다. 위에서 실험한 ACTH, PTH, LH의 동결건조 표준액은 반드시 냉동보관을 할 것을 권고한다. 이는 다른 동결건조표준액도 같은 방법으로 보관을 해야 할 것이다.

• 실천공학교육논문지
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• 제15권1호
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• pp.1-11
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• 2023

본 연구는 가상훈련 학습자의 가상훈련 콘텐츠 활용 만족도를 측정하는 도구 개발 및 타당화하는 것이 목적이다. 이를 위해 K대학교 온라인평생교육원에서 2011년부터 2022년까지 가상훈련 만족도로 활용한 문항을 토대로 기초문항을 도출하였다. 이후, K대학교 온라인평생교육원 포털 STEP에 접근한 학습자를 대상으로 온라인 설문조사를 실시하여 성실하게 응답한 총 491부를 최종분석에 사용하였다. 최종 사용한 491부의 자료는 기초문항분석, 탐색적 요인분석, 신뢰도 분석, 확인적 요인분석 등의 방법으로 분석하였다. 첫째, 기초문항분석에서 평균 4점이상, 왜도 ±2, 첨도 ±4이상의 수용기준을 벗어난 문항은 없었다. 둘째, 탐색적 요인분석 실시 후 도출된 가상훈련 콘텐츠 만족도 하위요인별 상관계수는 r=.682 ~ .822(p<.01)로 나타나 양호하였다. 하위요인별 신뢰도 계수는 콘텐츠 내용 .849, 콘텐츠 활용 .922, 시스템 및 운영지원 .841, 활용지속의향 .920, 전체신뢰도는 .956로 매우 높게 나타났다. 셋째, 확인적 요인분석 결과, 구성개념도는 .842 ~ .926로 나타나 추천기준치인 .7보다 높았으며, 평균분산추출도 .640 ~ .796으로 나타나 추천기준치인 .5보다 높아 각각 구성개념에 대한 대표성을 갖고 있다고 볼 수 있다. 가상훈련 학습자의 콘텐츠 만족도 구인 타당성을 검증한 결과로 콘텐츠 내용, 콘텐츠 활용, 시스템 및 운영지원, 활용지속의향 등 4개 요인 모형이 도출되었다. 본 연구는 가상훈련 학습자의 콘텐츠 만족도 측정도구를 실증적으로 개발하여 준거 틀과 기준을 제공했다는데 의의가 있다.