• Title/Summary/Keyword: statistical limits

Search Result 276, Processing Time 0.023 seconds

Assessing bioequivalence for highly variable drugs based on 3×3 crossover designs (고변동성 제제의 생물학적 동등성 평가에서 3×3 교차설계법 연구)

  • Park, Ji-Ae;Park, Sang-Gue
    • The Korean Journal of Applied Statistics
    • /
    • v.29 no.2
    • /
    • pp.279-289
    • /
    • 2016
  • Bioequivalence trials based on higher order crossover designs have recently been conducted for highly variable drugs since the Ministry of Korea Food and Drug Safety (MFDS) added new regulations in 2013 to widen bioequivalence limits for highly variable drugs. However, a statistical discussion of higher order crossover designs have not been discussed yet. This research proposes the statistical inference of bioequivalence based on $3{\times}3$ crossover design and discusses it with the MFDS regulations. An illustrated example is also given.

Application of Statistical Analysis to Analyze the Spatial Distribution of Earthquake-induced Strain Data (지진유발 변형률 데이터의 분포 특성 분석을 위한 응용통계기법의 적용)

  • Kim, Bo-Ram;Chae, Byung-Gon;Kim, Yongje;Seo, Yong-Seok
    • The Journal of Engineering Geology
    • /
    • v.23 no.4
    • /
    • pp.353-361
    • /
    • 2013
  • To analyze the distribution of earthquake-induced strain data in rock masses, statistical analysis was performed on four-directional strain data obtained from a ground movement monitoring system installed in Korea. Strain data related to the 2011 Tohoku-oki earthquake and two aftershocks of >M7.0 in 2011 were used in x-MR control chart analysis, a type of univariate statistical analysis that can detect an abnormal distribution. The analysis revealed different dispersion times for each measurement orientation. In a more comprehensive analysis, the strain data were re-evaluated using multivariate statistical analysis (MSA) considering correlations among the various data from the different measurement orientations. $T_2$ and Q-statistics, based on principal component analysis, were used to analyze the time-series strain data in real-time. The procedures were performed with 99.9%, 99.0%, and 95.0% control limits. It is possible to use the MSA data to successfully detect an abnormal distribution caused by earthquakes because the dispersion time using the 99.9% control limit is concurrent with or earlier than that from the x-MR analysis. In addition, the dispersion using the 99.0% and 95.0% control limits detected an abnormal distribution in advance. This finding indicates the potential use of MSA for recognizing abnormal distributions of strain data.

Effect of Ganjeonggyeok Acupuncture and Saengkankunbi-tang Treatment in the Changes of LFT and Lipid-obesity Index Values (간정격 시술 및 생간건비탕 투여가 간기능 및 비만도 변화에 미치는 영향)

  • Lee, Seong-No;Kim, Sang-Joo;Lee, Jin-Seok;Kim, Eun-Geol;Jang, Suk-Geun
    • Journal of Acupuncture Research
    • /
    • v.25 no.6
    • /
    • pp.47-54
    • /
    • 2008
  • Objectives : This study was aimed to figure out how effectively acupuncture treatment and herb-medicine work on patients with elevation of LFT value and lipid-obesity index. Methods : The subject were 23 patients visited to Dept. of Acupuncture and Moxibustion, Kwangdong Oriental Medicine Hospital, who complained chronic fatigue and wandering pain from Oct. 2007. to Oct. 2008. Before treatments, they were tested for LFT, total cholesterol, triglyceride, body fat ratio and obesity index. They were treated with Ganjeonggyeok acupuncture weekly for 1 month. During acupuncture treatments, we applied Sangkankunbi-tang to all patients twice a day. After 1 month, they were retested for LFT, total cholesterol, triglyceride, body fat ratio and obesity index. Results : 1. After treatments, we could get the result of dropping means of AST, ALT and $\gamma$-GTP value. Statistical significance of ALT and $\gamma$-GTP were recognized before and after treatments, but AST was not recognized. 2. After treatments, we also could get the result of dropping means of total cholesterol, triglyceride, body fat ratio and obesity index. Statistical significance of all values were recognized before and after treatments. 3. Among 23 patients, 10 cases were reported that they were not within normal limits at least one in AST, ALT and $\gamma$-GTP. After treatments of those patients, we could get the result of dropping means of AST, ALT and $\gamma$-GTP value. Statistical significance of all values were recognized before and after treatments. 4. Among 23 patients, 19 cases were reported that they were not within normal limits at least one in total cholesterol, triglyceride, body fat ratio and obesity index. After treatments of those patients, we could get the result of dropping means of total cholesterol, triglyceride, body fat ratio and obesity index. Statistical significance of all values were recognized before and after treatments. Conclusions : Though further study is necessary, our finding suggest that the conduction of Ganjeonggyeok acupuncture and Sangkankunbi-tang treatments have helped to decrease the figures of LFT and lipid-obesity index in patients.

  • PDF

Statistical Design of X Control Chart with Improved 2-of-3 Main and Supplementary Runs Rules (개선된 3 중 2 주 및 보조 런 규칙을 가진 X관리도의 통계적 설계)

  • Park, Jin-Young;Seo, Sun-Keun
    • Journal of Korean Society for Quality Management
    • /
    • v.40 no.4
    • /
    • pp.467-480
    • /
    • 2012
  • Purpose: This paper introduces new 2-of-3 main and supplementary runs rules to increase the performance of the classical $\bar{X}$ control chart for detecting small process shifts. Methods: The proposed runs rules are compared with other competitive runs rules by numerical experiments. Nonlinear optimization problem to minimize the out-of-control ARL at a specified shift of process mean for determining action and warning limits at a time is formulated and a procedure to find two limits is illustrated with a numerical example. Results: The proposed 2-of-3 main and supplementary runs rules demonstrate an improved performance over other runs rules in detecting a sudden shift of process mean by simultaneous changes of mean and standard deviation. Conclusion: To increase the performance in the detection of small to moderate shifts, the proposed runs rules will be used with $\bar{X}$ control charts.

An Experimental Estimation of Two Detection Limit Models

  • Ma Chang-Jin;Tohno Susumu;Kasahara Mikio;Kang Gong-Unn
    • Journal of Korean Society for Atmospheric Environment
    • /
    • v.20 no.E1
    • /
    • pp.29-33
    • /
    • 2004
  • In environmental studies, decisions are often made on the analytical data indicating certain contaminants as being 'detected' or 'non-detectible.' Since detection limits are analytical method specific, one has to first review the concepts and definitions associated with analytical method systems and specifications. In this study, the experimental analytical values for a series of low level standards (for an ionic species) were used as an example to estimate two different method detection limits (MDL). The scores of EPA's MDL and Pallesen's MDL determined by real analytical scores are 0.0575 and 0.0561 mg/L, respectively for our nitrate data. These scores determined by two different MDL models are roughly similar, while there are apparent differences between two methods with respect to statistical and systematical procedure. However, determination of MDL for one's laboratory provides some practical applications which helps to assure one's regulating authorities that one's measured scores are accurate.

A Control Chart Method Using Quartiles for Asymmetric Distributed Processes (비대칭 분포를 따르는 공정에서 사분위수를 이용한 관리도법)

  • Park Sung-Hyun;Park Hee-Jin
    • The Korean Journal of Applied Statistics
    • /
    • v.19 no.1
    • /
    • pp.81-96
    • /
    • 2006
  • This paper proposes a simple control chart method which can be practically used for asymmetric process data where the distribution is unknown. If we use the Shewhart type control charts which are based on normality assumption for the asymmetric process data, the type I error could increase as the asymmetry increases and the effectiveness of control chart to control variation decreases. To solve such problems, this paper suggests to calculate the control limits based on the quartiles. If we obtain the control limits by such quartile method, the type I error could decrease and it looks much more practical for asymmetric distributed process data.

Developing a Web-based System for Computing Pre-Harvest Residue Limits (PHRLs)

  • Chang, Han Sub;Bae, Hey Ree;Son, Young Bae;Song, In Ho;Lee, Cheol Ho;Choi, Nam Geun;Cho, Kyoung Kyu;Lee, Young Gu
    • Agribusiness and Information Management
    • /
    • v.3 no.1
    • /
    • pp.11-22
    • /
    • 2011
  • This study describes the development of a web-based system that collects all data generated in the research conducted to set pre-harvest residue limits (PHRLs) for agricultural product safety control. These data, including concentrations of pesticide residues, limit of detection, limit of quantitation, recoveries, weather charts, and growth rates, are incorporated into a database, a regression analysis of the data is performed using statistical techniques, and the PHRL for an agricultural product is automatically computed. The development and establishment of this system increased the efficiency and improved the reliability of the research in this area by standardizing the data and maintaining its accuracy without temporal or spatial limitations. The system permits automatic computation of the PHRL and a quick review of the goodness of fit of the regression model. By building and analyzing a database, it also allows data accumulated over the last 10 years to be utilized.

  • PDF

Relationships among various factors used in calculating control limits of control chart for variable data (계량형 관리도의 관리규격 계산에 사용되는 여러 계수값 사이의 관계)

  • 박성균;김영균
    • Journal of Korean Society for Quality Management
    • /
    • v.30 no.4
    • /
    • pp.86-93
    • /
    • 2002
  • There are many different factors used in calculating control limits of control chart for variable data. Specially these factors are divided into two groups such as "no given standard" and "given standard"(namely, for analysis and management), but many kind of factors give rise to confusion. Therefore, It is necessary to manifest relationships among factors for easy application regardless of subgroup size. Many SQC textbooks show us plainly these factors, but do not have enough for adequate explanation of relationships among factors. Besides, notation of these factors of SQC textbook isn't coincide with another one, so necessity to the coincidence for the notation of the factors is highlighted during my work recently. In this study, the close examination about relationships among various factors (A-A3, B3-B6, D1-D4, C4, d2, d3 etc) was carried out. Spread sheet results are presented for getting factors according to subgroup size, by grouping as the case of "no given standard" and "given standard". How are these factors to be applied in statistical package (ex, Minitab) have been analyzed using a series of sample data. analyzed using a series of sample data.

Design of Median Control Chart for Nonnormally Distributed Processes (비정규분포공정(非正規分布工程)에서 메디안특수관리도(特殊管理圖)의 모형설계(模型設計))

  • Sin, Yong-Baek
    • Journal of Korean Society for Quality Management
    • /
    • v.15 no.2
    • /
    • pp.10-19
    • /
    • 1987
  • Statistical control charts are useful tools to monitor and control the manufacturing processes and are widely used in most Korean industries. Many Korean companies, however, do not always obtain desired results from the traditional control charts by Shewhart such as the $\overline{X}$-chart, X-chart, $\widetilde{X}$-chart, etc. This is partly because the quality charterstics of the process are not distributed normally but are skewed due to the intermittent production, small lot size, etc. In the Shewhart $\overline{X}$-chart, which is the most widely used one in Korea, such skewed distributions make the plots to be inclined below or above the central line or outside the control limits although no assignable causes can be found. To overcome such shortcomings in nonnormally distributed processes, a distribution-free type of confidence interval can be used, which should be based on order statistics. This thesis is concerned with the design of control chart based on a sample median which is easy to use in practical situation and therefore properties for nonnormal distributions may be easily analyzed. Control limits and central lines are given for the more famous nonnormal distributions, such as Gamma, Beta, Lognormal, Weibull, Pareto, and Truncated-normal distributions.

  • PDF

An Analytical Approach to Derive the Quality Loss Function with Multi-characteristics by Taguchi's Quality Loss Concept (다구찌 품질손실개념에 의한 다특성치 품질손실함수 도출의 분석적 접근방법)

  • Pai, Hoo Seok;Lim, Chae Kwan
    • Journal of Korean Society for Quality Management
    • /
    • v.48 no.4
    • /
    • pp.535-552
    • /
    • 2020
  • Purpose: The main theme of this study is to derive a specific quality loss function with multiple characteristics according to the same analytical structure as the single characteristic quality loss function of Taguchi. In other words, it presents an analytical framework for measuring quality costs that can be controlled in practice. Methods: This study followed the analytical methodology through geometric, linear algebraic, and statistical approaches Results: The function suggested by this study is as follows; $$L(x_1,x_2,{\cdots},x_t)={\sum\limits_{i=1}^{t}}k_i\{x_i+{\sum\limits_{j=1}^{t}}\({\rho}_{ij}{\frac{d_i}{d_j}}\)x_j\}x_i$$ Conclusion: This paper derived the quality loss function with multiple quality characteristics to expand the usefulness of the Taguchi quality loss function. The function derived in this paper would be more meaningful to estimate quality costs under the practical situation and general structure with multiple quality characteristics than the function by linear algebraic approach in response surface analysis.