• Title/Summary/Keyword: Test Validation

Search Result 1,808, Processing Time 0.026 seconds

Bioequivalence Test of Triflusal Capsules (트리플루살 캅셀의 생물학적 동등성 평가)

  • 박정숙;이미경;박경미;김진기;임수정;최성희;민경아;김종국
    • Biomolecules & Therapeutics
    • /
    • v.9 no.4
    • /
    • pp.291-297
    • /
    • 2001
  • The bioequivalence of two triflusal products was evaluated with 20 healthy volunteers following single oral dose according to the guidelines of Korea Food and Drug Administration (KFDA). Trisa $l^{R}$ capsule (Whanin Pharm. Corp., Korea) and Disgre $n^{R}$ capsule (Myung-In Pharm. Corp., Korea) were used as test product and reference product, respectively. Both products contain 300 mg of trifusal. One capsule of test product or reference product was orally administered to the volunteers, respectively, by randomized two period crossover study (2$\times$2 Latin square method). Blood samples were taken at predetermined time intervals for 4 hours and the determination of trifusal was accomplished using semi-microbore HPLC equipped with automated column switching system. The analytical method with HPLC was validated according to the Bioanalytic Method Validation guideline by F7A prior to determining the plasma samples. The pharmacokinetic parameters (AU $C_{0-4h}$ $C_{max}$ and $T_{max}$) were calculated and ANOVA test was utilized for statistical analysis of parameters. As a result of the assay validation, the limit of quantification of trifusal in human plasma by current assay procedure was 50 ng/ml using 500 $\mu$l of plasma. The accuracy of the assay was from 97.76% to 116.51% while the intra-day and inter-day coefficient of variation of the same concentration range was less than 15%. Average drug concentration at the designated time intervals and pharmacokinetic parameters calculated were not significantly different between two products (p>0.05). The difference of mean AU $C_{olongrightarrow4hr}$, $C_{max}$, and $T_{max}$ between the two products (2.92, 4.39, and -2.44%, respectively) were less than 20%. The power (1-$\beta$) and treatment difference ($\Delta$) for AU $C_{olongrightarrow4hr}$ and $C_{max}$ were more than 0.8 and less than 0.2, respectively. Although the power for $T_{max}$ was under 0.8, $T_{max}$ of the two products was not significantly different from each other (p>0.05). These results satisfied the criteria of KFDA guideline for bioequivalence, indicating the two products of triflusal were bioequivalent.quivalent.ent.ent.

  • PDF

Establishment and Validation of Gold Amalgamation Method for the Quantitation of Thimerosal in Biological Products (생물학적제제의 치메로살 함량 정량을 위한 가열기화 아말감 흡광도법의 확립 및 검증)

  • Kim, Byung-Chul;Kim, Do-Keun;Hong, Sung-Hwa;Kim, Yeon-Hee;Lim, Jong-Mi;Won, Yun-Jung;Kim, Seok-Hwan;Hong, Ji-Young;Yun, Young-Min;Kim, Jae-Ok
    • YAKHAK HOEJI
    • /
    • v.55 no.4
    • /
    • pp.284-288
    • /
    • 2011
  • The test method for biologics of lot release system is based on 'Test procedure and specification for biological products,' generally, thimerosal content is measured by chemical analysis using O.D. In this study, the comparative analysis was carried out using the gold amalgamation method for thimerosal content was compared to the existing methods, which are described above. The gold amalgamation method, which uses atomic absorption spectrophotometry, was meets all the method validation acceptance criteria. It is considered to be proper as the assay and identification test for thimerosal. In this study, the comparative analysis was performed three times. As a result, gold amalgamation method is more convenient and easy to perform as this assay doesn't have pre-treatment procedure. Also this assay showed good precision and reproducibility compared to the conventional method. Therefore, it is appropriate to alternate the assay method of thimerosal from the conventional chemical analysis to gold amalgamation method to improve the credibility of lot release system and the quality control of biologics, by standardizing test method.

Forecasting KOSPI 200 Volatility by Volatility Measurements (변동성 측정방법에 따른 KOSPI200 지수의 변동성 예측 비교)

  • Choi, Young-Soo;Lee, Hyun-Jung
    • Communications for Statistical Applications and Methods
    • /
    • v.17 no.2
    • /
    • pp.293-308
    • /
    • 2010
  • In this paper, we examine the forecasting KOSPI 200 realized volatility by volatility measurements. The empirical investigation for KOSPI 200 daily returns is done during the period from 3 January 2003 to 29 June 2007. Since Korea Exchange(KRX) will launch VKOSPI futures contract in 2010, forecasting VKOSPI can be an important issue. So we analyze which volatility measurements forecast VKOSPI better. To test this hypothesis, we use 5-minute interval returns to measure realized volatilities. Also, we propose a new methodology that reflects the synchronized bidding and simultaneously takes it account the difference between overnight volatility and intra-daily volatility. The t-test and F-test show that our new realized volatility is not only different from the realized volatility by a conventional method at less than 0.01% significance level, also more stable in summary statistics. We use the correlation analysis, regression analysis, cross validation test to investigate the forecast performance. The empirical result shows that the realized volatility we propose is better than other volatilities, including historical volatility, implied volatility, and convention realized volatility, for forecasting VKOSPI. Also, the regression analysis on the predictive abilities for realized volatility, which is measured by our new methodology and conventional one, shows that VKOSPI is an efficient estimator compared to historical volatility and CRR implied volatility.

Development and Validation of Tool for the Assessment of Employment Preparedness for People with Visual Impairments (시각장애인 고용준비도 검사지 개발 및 타당화 연구)

  • Jun, Young Hwan;Lee, Tae Hun;Lee, Jae Ho
    • 재활복지
    • /
    • v.21 no.1
    • /
    • pp.27-46
    • /
    • 2017
  • The purpose of this study is to develop tool for the assessment of employment preparedness for people with visual impairments. First, we developed a draft assessment factors. Expert opinion survey, delphi survey, pilot test were conducted to modify contents of the factors. Actual assessments were carried out to test the reliability and validity of the developed tool targeting job seeker with visual disabilities. The total number of valid samples are 253. Principal component analysis, confirmatory factors analysis, and correlation analysis were used for the validity test. Chronbach' alpha analysis was used for the reliability test. As a result of the reliability analysis, the reliability coefficient showed good level of 0.88-0.92. As a result of the factor analysis, it was confirmed that the composition concept of 9 factors were well reflected. The correlation coefficient between employment preparedness tool and job screening tool was 0.501, Which was statistically significant. Therefore, it was evaluated as having a concurrent validity. Finally, it was confirmed that the assessment of employment preparedness for people with visual impairments was valid as assessment tool.

Influence of Self-driving Data Set Partition on Detection Performance Using YOLOv4 Network (YOLOv4 네트워크를 이용한 자동운전 데이터 분할이 검출성능에 미치는 영향)

  • Wang, Xufei;Chen, Le;Li, Qiutan;Son, Jinku;Ding, Xilong;Song, Jeongyoung
    • The Journal of the Institute of Internet, Broadcasting and Communication
    • /
    • v.20 no.6
    • /
    • pp.157-165
    • /
    • 2020
  • Aiming at the development of neural network and self-driving data set, it is also an idea to improve the performance of network model to detect moving objects by dividing the data set. In Darknet network framework, the YOLOv4 (You Only Look Once v4) network model was used to train and test Udacity data set. According to 7 proportions of the Udacity data set, it was divided into three subsets including training set, validation set and test set. K-means++ algorithm was used to conduct dimensional clustering of object boxes in 7 groups. By adjusting the super parameters of YOLOv4 network for training, Optimal model parameters for 7 groups were obtained respectively. These model parameters were used to detect and compare 7 test sets respectively. The experimental results showed that YOLOv4 can effectively detect the large, medium and small moving objects represented by Truck, Car and Pedestrian in the Udacity data set. When the ratio of training set, validation set and test set is 7:1.5:1.5, the optimal model parameters of the YOLOv4 have highest detection performance. The values show mAP50 reaching 80.89%, mAP75 reaching 47.08%, and the detection speed reaching 10.56 FPS.

The gene expression programming method to generate an equation to estimate fracture toughness of reinforced concrete

  • Ahmadreza Khodayari;Danial Fakhri;Adil Hussein, Mohammed;Ibrahim Albaijan;Arsalan Mahmoodzadeh;Hawkar Hashim Ibrahim;Ahmed Babeker Elhag;Shima Rashidi
    • Steel and Composite Structures
    • /
    • v.48 no.2
    • /
    • pp.163-177
    • /
    • 2023
  • Complex and intricate preparation techniques, the imperative for utmost precision and sensitivity in instrumentation, premature sample failure, and fragile specimens collectively contribute to the arduous task of measuring the fracture toughness of concrete in the laboratory. The objective of this research is to introduce and refine an equation based on the gene expression programming (GEP) method to calculate the fracture toughness of reinforced concrete, thereby minimizing the need for costly and time-consuming laboratory experiments. To accomplish this, various types of reinforced concrete, each incorporating distinct ratios of fibers and additives, were subjected to diverse loading angles relative to the initial crack (α) in order to ascertain the effective fracture toughness (Keff) of 660 samples utilizing the central straight notched Brazilian disc (CSNBD) test. Within the datasets, six pivotal input factors influencing the Keff of concrete, namely sample type (ST), diameter (D), thickness (t), length (L), force (F), and α, were taken into account. The ST and α parameters represent crucial inputs in the model presented in this study, marking the first instance that their influence has been examined via the CSNBD test. Of the 660 datasets, 460 were utilized for training purposes, while 100 each were allotted for testing and validation of the model. The GEP model was fine-tuned based on the training datasets, and its efficacy was evaluated using the separate test and validation datasets. In subsequent stages, the GEP model was optimized, yielding the most robust models. Ultimately, an equation was derived by averaging the most exemplary models, providing a means to predict the Keff parameter. This averaged equation exhibited exceptional proficiency in predicting the Keff of concrete. The significance of this work lies in the possibility of obtaining the Keff parameter without investing copious amounts of time and resources into the CSNBD test, simply by inputting the relevant parameters into the equation derived for diverse samples of reinforced concrete subject to varied loading angles.

Fatigue performance of a new type PSC girder (신형식 PSC거더의 피로 성능)

  • Choi, Sang-Hyun;Lee, Chang-Soo;Kim, Tae-Kyun;Eui, Chul-Soo
    • Proceedings of the KSR Conference
    • /
    • 2011.05a
    • /
    • pp.965-972
    • /
    • 2011
  • Unlike metallic materials, the importance of fatigue performance of concrete has been ignored. However, it is reported that environmental effects, if it cause deterioration, may increase the risk of fatigue failure under repeated loadings. In case of railroad bridges, the risk may increase due to highly periodic, repetitive, heavier nature of train load, which runs through the fixed passage called the track. Especially, when new material or structure is implemented for a main bridge member, experimental validation should be performed to avoid damage or failure due to unexpected behavior. In this paper, the fatigue performance of an IT girder is examined via a repeated loading test. The IT girder is a new type of a prestressed concrete (PSC) girder with two prestressed H-beams in the top of the girder, which provide additional sectional capacity, and it can be applied to the span longer than 30m which is a typical limit for a usual PSC girder. To obtain the fatigue performance, a 10m IT girder specimen is designed, and a repeated load test is performed by applying the cyclic load two million times. The fatigue performance of the girder is examined according to the Japanese and the CEB-FIB design codes. The fatigue test result shows that the IT girder satisfies both design codes.

  • PDF

Translation and Validation of Korean Version of Hall's Professionalism Inventory (간호의 전문직업성 척도 개발을 위한 Hall의 전문직업성 척도 번역 및 동등성 비교)

  • Kim, Yeoun-Soo;Baek, Hee-Chong
    • Journal of Korean Academy of Nursing Administration
    • /
    • v.13 no.4
    • /
    • pp.509-515
    • /
    • 2007
  • Purpose: The purpose of this study was to translate and validate the Korean version of Hall's Professional Inventory(HPI) scale to assess levels of professionalism among Korean registered nurses. Method: The 25 item HPI scale was translated and content review was done by translation panel. After the content review, a bilingual nursing scholar performed the back-translation into English. A semantic equivalence test was conducted with 5 American nursing professors. A pilot study was conducted with a sample of 164 registered nurses in Korea to test the validity and reliability of the translated HPI. Result: The content equivalence for translated version of HPI was validated by a translation panel. The finding of the semantic equivalence test of back-translated version was 72.8%. The Cronbach's alpha for the Korean version of HPI was .820. Conclusions: This study provides information about the issues of translating an instrument such as the HPI. The Korean version of the HPI is a valid and reliable instrument and can have psychometric properties equivalent to those of the original HPI. The translated version could be used for assessing levels of professionalism for other health care professionalism as well as nurses.

  • PDF

Modeling of the Temperature-Dependent and Strain Rate-Dependent Dynamic Behavior of Glass Fiber-Reinforced Polyurethane Foams (유리 섬유 강화 폴리우레탄 폼의 온도 및 변형률 속도 의존 재료 거동 모델링)

  • Lee, Dong-Ju;Shin, Sang-Beom;Kim, Myung-Hyun
    • Journal of Ocean Engineering and Technology
    • /
    • v.33 no.6
    • /
    • pp.547-555
    • /
    • 2019
  • The purpose of this study was to establish a numerical model of polyurethane foam (PUF) to simulate the dynamic response and strength of membrane-type Liquefied natural gas (LNG) Cargo containment system (CCS) under the impact load. To do this, initially, the visco-plastic behavior of PUF was characterized by testing the response of the PUF to the impact loads with various strain rates as well as PUF densities at room temperature and at cryogenic conditions. A PUF material model was established using the test results of the material and the FE analysis. To verify the validation of the established material model, simulations were performed for experimental applications, e.g., the dry drop test, and the results of FEA were compared to the experimental results. Based on this comparison, it was found that the dynamic response of PUF in dry drop tests, such as the reaction force and fracture behaviors, could be simulated successfully by the material model proposed in this study.

Analysis Study on Ultimate Strength of Single-shear Bolted Connections with Austenitic Stainless Steel(STS201) with Varied End and Edge distances (연단거리를 변수로 갖는 오스테나이트계 스테인리스강(STS201) 일면전단 볼트접합부의 최대내력에 관한 해석연구)

  • Cha, Eun-Young;Hwang, Bo-Kyung;Lee, Hoo-Chang;Kim, Tae-Soo
    • Journal of the Korea institute for structural maintenance and inspection
    • /
    • v.21 no.5
    • /
    • pp.1-11
    • /
    • 2017
  • This study focused on the ultimate behaviors(ultimate strength and fracture mode ) of single shear bolted connection with austenitic sainless steel(STS201) and curling effect on the ultimate strength using finite element analysis based on test results. Main variables are end distance in the parallel direction to loading and edge distance in the perpendicular direction to loading. The validation of finite element analysis procedures was verified through the comparisons of ultimate strength, fracture mode and curling(out-of-plane deformation) occurrence between test results and numerical predictions. Curling was observed in both test and analysis results and it reduced the ultimate strength of single- shear bolted connections with relatively long end distances. Strength reduction ratios caused by curling were estimated quantitatively by maximum 19%, 32%, respectively for specimens with edge distance, 48 mm and 60 mm compared with strengths of uncurled connections with restrained out-of-plane deformation. Finally, analysis strengths were compared with current design strengths and it is found that design block shear equations did not provide the accurate predictions for bolted connections with strength reduction by curling.