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Bioavailability Evaluation of Two Ceftriaxone Formulations Using Two Way Crossover Design in Voluteers

  • Kwon, Kwang-Il;Bok, Soo-Jin;Kim, Moo-Heon;Lee, Chang-Hyun
    • Archives of Pharmacal Research
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    • v.18 no.4
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    • pp.237-242
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    • 1995
  • For the vioequivalence study of two ceftriaxone injection formulations ($Rocephin{\circledR}$ ; Roche, and Triaxone ; Hanmi0, the HPLC analytical method for the analysis of ceftriaxone in plasma was used. Fourteen healthy volunteers completed the study and each subject were IM in jected signle doses (1 g) of the test and the reference formulations in a two-way crossover design with an one week drug free interval between doses. Following each administration, plasma concentrations of ceftrixone were monitored over a period of 24 h. Bioequivalence parameters $AUC_{24th}, {\;}T_{max}, {\;}C_{max}$ and MRT determined from the data obtained for the two formulations were examined by analyses of variance (ANOVA) and other criteria and tests for bioequivalence. Results of ANOVA and confidence limits of test/reference ratios of $AUC_{24th}, {\;}T_{max}, {\;}C_{max}$ and MRT, and statistical tests indicated the bioequivalence of the two formulations (i.e., test/reference ratio was within $100{\pm}20%$) except for $T_{max}$ The mean of $T_{max}$ showed only 6. 9% difference from the reference but the detection limit was 22.5% which is slightly over the 20% criteria. No pharmacokinetic parameters including Ka, Kel, Vd and Cl indicated significant difference in between the two fomulations. It was concluded that the data yielded fro the two cefriaxone formulations demonstrated that they were bioequivalent.

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Electronic-Hydraulic Hitch Control System for Agricultural Tractor -Position Control- (트랙터의 전자유압식(電子油壓式) 히치제어 시스템에 관한 연구(硏究)(I) -위치제어(位置制御)-)

  • Yoo, S.N.;Ryu, K.H.;Park, J.G.
    • Journal of Biosystems Engineering
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    • v.14 no.3
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    • pp.168-180
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    • 1989
  • This study was attempted to develop the electronic-hydraulic hitch control system for position control of tractor plow and investigate the control performance of the system through experiments. Experiments were carried out to investigate the responses of the system to the step and sinusoidal inputs in position control. The effects of control mode, hydraulic flow rate, reference deadband, and proportional constant on control performance of the system were investigated. The following conclusions were derived from the study; 1. For the position control system operated on on-off control mode, positions of implement were controlled within ${\pm}0.73^{\circ}{\sim}{\pm}1.46^{\circ}$ in rockshaft angle to the reference position when the hydraulic flow rates were 5~15 l/min. For the position control system operated on PWM control mode, positions of implement were controlled within ${\pm}0.73^{\circ}$ to the reference position regardless of hydraulic flow rates. It means that the implement could be positioned more accurately to the reference position on PWM control mode than on on-off control mode. 2. As results of the frequency responses of the position control systems, no clear difference in control performance between on-off control and PWM control modes was found. As the hydraulic flow rates increased, the corner frequencies of amplitude attenuation and phase-angle change increased. It means that the control performance of the system could be improved as the hydraulic flow rate increases.

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Clinical Pharmacokinetic Profiles of Hanmi SMEDDS Silymarin Soft Capsule Preparation (한미 SMEDDS 실리마린 연질캅셀 제제의 임상약동학적 특성)

  • 박민수;유내춘;김경환
    • Biomolecules & Therapeutics
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    • v.8 no.3
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    • pp.269-275
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    • 2000
  • Silibinin(silybin) is the active component of silymarin from Silybum marianum and has hepato-protective effect. It is water-insoluble and has low bioavailability. To improve its bioavailability, self-micro-emulsifying drug delivery system (SMEDDS) has been developed by Hanmi Pharmaceutical Company (Silyma $n^{R}$ 140 soft capsule). In this study, the pharmacokinetic profiles of Silyma $n^{R}$ were examined and compared it with a reference preparation, L Caps140 of B Pharmaceutical Company. This study was approved by Yonsei University Severance Hospital IRB(approval No. CR0004) and followed the bioequivalence test guideline of Korean FDA. Eighteen healthy adult volunteers were allocated based on 2$\times$2 Latin square cross-over design. They were given 2 capsules (each contains silymarin 140 mg (60 mg as silibinin)) of either drug at each period and crossed over after a week of drug-free washout period. Blood concentration of silibinin was measured by HPLC. The $C_{max}$ and AUC of the Silyma $n^{R}$ were 1542.0 $\pm$ 402.7 ng/ml and 3323.3 $\pm$ 824.7 ng.h/ml, respectively, and were significantly higher than those of reference preparation. The Tmax was 0.8 $\pm$ 0.3 h and significantly shorter than reference preparation. The $K_{e}$ and $T_{1}$2/ of both drugs were comparable. Percent differences in means against reference preparation were +88.3% for AUC, +222.6% for $C_{max}$, and -61.1% for $T_{max}$./.>././.>./.

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A Study on the Functional Design of Classification Management System of Public Organizations (정부산하공공기관의 분류체계관리시스템 기능 설계 연구)

  • Oh, Jin Kwan
    • The Korean Journal of Archival Studies
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    • no.53
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    • pp.201-228
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    • 2017
  • Recently, public organizations have been improving the classification in order to introduce records management reference table in accordance with the act on the management of public archives. However, there is no system to mount the revised records management reference table, and there is a problem in usability. The purpose of this study is to design a system function to manage the classification which is the foundation of records management for public organizations. In order to design the function, interviews with the records management specialists of the five public organizations were conducted. Based on this, we have designed a multi-classification system registration function, a hierarchical structure setting function of records, and a record management standard management function.

Impulse Buying Behavior in Distribution Centers of Kathmandu

  • Bharat RAI;Rewan Kumar DAHAL;Bhupendra Jung SHAHI;Binod GHIMIRE
    • Journal of Distribution Science
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    • v.21 no.5
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    • pp.19-29
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    • 2023
  • Purpose: The study's primary objective was to pinpoint the variables impacting consumers' impulsive purchasing decisions in the distribution centers in Kathmandu, the capital city of Nepal. Research design, data, and methodology: The independent variables used to identify consumer impulse buying behavior were the in-store displays, store employee behavior, reference groups, and promotional activities. A 6-point Likert scale questionnaire was employed for collecting the primary data from customers at the retail center of Kathmandu. The study's sample size was 396, employing a convenient sampling method. Statistical Package for the Social Sciences (SPSS) and Analysis of a Moment Structures (AMOS) have been used to show the relationships between dependent and independent variables. Results: The outcome of the path analysis using structural equation modeling demonstrates that in-store displays, reference groups, and store employees' behavior significantly influence the customers' impulse buying decisions in the distribution center. Additionally, it has been discovered that promotional activities have no significant impact on consumers' impulsive purchasing decisions made at the retail center of Kathmandu. Conclusions and Implications: The study's findings indicate that the actions of store personnel, reference groups, and in-store displays significantly contribute to the acceleration of impulsive purchases. Such findings provide researchers and business executives with a road map for the future.

Preliminary Selection of Safety-Relevant Radionuclides for Long-Term Safety Assessment of Deep Geological Disposal of Spent Nuclear Fuel in South Korea

  • Kyu Jung Choi;Shin Sung Oh;Ser Gi Hong
    • Journal of Nuclear Fuel Cycle and Waste Technology(JNFCWT)
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    • v.21 no.4
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    • pp.451-463
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    • 2023
  • With South Korea increasingly focusing on nuclear energy, the management of spent nuclear fuel has attracted considerable attention in South Korea. This study established a novel procedure for selecting safety-relevant radionuclides for long-term safety assessments of a deep geological repository in South Korea. Statistical evaluations were performed to identify the design basis reference spent nuclear fuels and evaluate the source term for up to one million years. Safety-relevant radionuclides were determined based on the half-life criteria, the projected activities for the design basis reference spent nuclear fuel, and the annual limit of ingestion set by the Nuclear Safety and Security Commission Notification No. 2019-10 without considering their chemical and hydrogeological properties. The proposed process was used to select 56 radionuclides, comprising 27 fission and activation products and 29 actinide nuclides. This study explains first the determination of the design basis reference spent nuclear fuels, followed by a comprehensive discussion on the selection criteria and methodology for safety-relevant radionuclides.

Development of Methyl 2-aminobenzoate Reference Material in a Biocidal Product Matrix

  • So Yeon Lee;Kyungmin Kim;Junghyun Kim;Wooil Kim;Han Bin Oh
    • Mass Spectrometry Letters
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    • v.14 no.4
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    • pp.166-172
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    • 2023
  • The utilization of methyl 2-aminobenzoate as a biocide and pesticide has raised concerns regarding its potential toxicity. To assess its safety, it is crucial to determine its quantity and related toxicity using reference materials (RMs) or certified reference materials (CRMs). As an RM and CRM containing methyl 2-aminobenzoate within a biocidal product matrix is currently unavailable, this study aimed to produce a high-quality RM containing methyl 2-aminobenzoate, ensuring its homogeneity and stability, following the ISO Guide 35 and ISO 17034. The study determined that the produced RM exhibited homogeneity, as indicated by a calculated F-value (1.91) smaller than the critical F-value (3.02). In the assessment of isochronous short-term stability, the slope of the linear regression for the RM showed no statistically significant difference from zero when stored at temperatures of 4, 18, and 60 ℃ for 4 weeks. Regarding classical long-term stability, the RM demonstrated sustained stability over the course of one year when stored at 4 ℃. This study has successfully developed an RM for monitoring methyl 2-aminobenzoate in biocides and pesticides. Its quality underwent rigorous evaluation, confirming both homogeneity and stability.

Standardization of Reference Values among Laboratories of Korean Association of Health Promotion-3rd Attempt (한국건강관리협회 임상병리검사결과 참고범위 설정 및 표준화 (3회차))

  • Lee, Gap-No;Yun, Jong-Hyeon;Jo, Han-Ik;Jeong, Hu-Geun;Park, Hyeon-Mo;Yun, Cheong-Ha;Kim, Sang-In
    • Journal of Korea Association of Health Promotion
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    • v.2 no.1
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    • pp.1-8
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    • 2004
  • Background : Since 2001 the Korean Association of Health Promotion has attempted to establish her own reference valves that can be used in her all fifteen branch laboratories instead of using those adapted from the published data or there commended data by the reagent companies supplied as inserts. However, the previous two reference values derived from the statistics(year 2001 and 2002) were need to adjust to apply to actual practice. Besides there was an unavoidable situation that the reagent has to be changed to other companies in 2002 that creates another statistical problem. Subsequently, the third attempt to derive the reference ranges of tests in KAHP to solve those problems and define common)v acceptable reference ranges was done and and reported here. Methods : Al1 the results performed during January 2, 2003 through September 30, 2003 were collected in Excel tile format. All the data include dthe necessary information such as age and sex. The age was grouped in six; baby(0-3y), children(4-l2y), adolescent(13-l8y), adult(19-S4y), younger elderly (65-79y),old elderly(oyer 80y), with references of statistics in medical informatics and WHO classification. The data were statistically analyzed with SAS 6.04 for-Gaussian distribution as the previous two occasions. None of the tests showed Gaussian distribution. These procedures had been repeated twice or three times after trimming out the results lying outside three standard deviations. Though, all the tests showed non-Gaussian distribution. Subsequently, the reference ranges were defined in the range from the point of lower 2.5% to the point of higher 97.5 %. And in case the lower range could be "0", the reference ranges were defined in the range of 0 to 95%.Results : The reference ranges of most of 56 test items were newly assigned. Also with adaptation of the recommendation of WHO etc. on fasting blood sugar, hemoglobin, cholesterol. Among these there were eight tests that needed reference ranges by the age groups and nine tests by the sex. Conclusions : The third attempt will credit more the reference range of all15 laboratories of Korean Association of Health Promotion, which will be essential part of the better service to the patient and clients to visit KAHP.

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A Study on the "Terms of Reference" in the ICC Rules of Arbitration (ICC 중재규칙(ICC Rules of Arbitration)의 "위탁조건"(Terms of Reference)에 관한 연구)

  • Oh, Won-Suk
    • THE INTERNATIONAL COMMERCE & LAW REVIEW
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    • v.31
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    • pp.81-106
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    • 2006
  • The Terms of Reference are one of the most distictive features of ICC Arbitration. No document of this type is required to be drawn up under the rules of any of the other major international arbitration institutions. The purpose of this paper is to examine their advantages and to introduce main contents provided in Article 18 of ICC Rules of Arbitration, which results in the wide recognition of the Terms of Reference. As the volume of our international commercial transaction ranks almost ten in the world, the frequency using ICC Arbitration is expected to increase continuously. The Terms of Reference provide the parties and the arbitrators with an opportunity to identify and agree on procedural and other matters, such as the applicable law, the language of the arbitration and the timetable for the arbitration. They also afford the parties and the arbitrators to identify the substantive issues that are addressed in the arbitration and to delimit the precise scope of the Arbitract Tribunal's mandate. The contents of the Terms of Reference which are provided in Article 18(1) include the summary of parties claims, the list of issues and procedural rules. For the effects of the Terms of Reference, they are not intended to replace the parties' arbitration agreement. But they may in certain circumstances be regarded as a form of submission agreement. Article 18(2) provides that the Terms of Reference shall be signed by the parties and the Arbitral Tribunal, and requires the Arbitral Tribunal to transmit a signed copy of the Terms of Reference to the Court within two months of the date on which the file was transmitted to it by the Secretariat. The Court enjoys the power to extend the two-month time limit for the Terms of Reference on the reasoned request of the Arbitral Tribunal or on the Court's own initiative. Article 18(3) provides that if any of the parties refuses to take part in the drawing up of the Terms of Reference or to sign the same, they shall be submitted to the Court for approval. Article 18(4) allows the Arbitral Tribunal to extablish in a separate document a provisional timetable. This is a provision that encourages the acceleration of the arbitraction process. The timetable provided for therein is merely "provisional" and may be modified, as necessary, during the course of the arbitration.

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The effect of anchor extremity and question difficulty on anchoring effect (기준점의 극단성과 문항 난이도가 기준점 효과에 미치는 영향)

  • Lee, Myoungjin;Lee, Yoonhyoung;Kim, Kyungil
    • Korean Journal of Cognitive Science
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    • v.33 no.1
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    • pp.77-93
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    • 2022
  • Previous studies have reported that a plausible reference point has a greater anchoring effect than an extreme reference point. It is also known that the anchoring effect decreases when the individual's level of knowledge related to a given item is high. However, there has been no study examining the interaction of the plausibility of the reference point and the difficulty of the given question. Therefore, in this study, the effect of the reference plausibility and the difficulty of the questions on the anchoring effect were examined. The relationship between the response confidence and the anchoring effect was also examined. To do so, easy and difficult questions, plausible and extreme reference points were selected through preliminary research. The experiment was conducted following the 'standard anchoring task procedure'. As results, the extremity of the reference point and the difficulty of the question affected the size of the anchoring effect respectively. The difficulty of the question also affected the confidence of the response. Specifically, when a plausible reference point was presented and when a difficult question was presented, the anchoring effects were increased. In addition, the lower the confidence in one's performances, the greater the influence of the reference point when an extreme reference point was presented. These results show that the plausibility of the given reference point and the difficulty of the item have different effects on the magnitude of the anchoring effect and the degree of confidence. The results of this study support the attitude change perspective regarding the anchoring effect, which suggests that the anchoring effect varies depending on the characteristics of the reference point and the individual's knowledge.