• Title/Summary/Keyword: Interval criteria

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Bioequivalence Study of Ranitidine Tablet

  • Shim, Chang-Koo;Hong, Jae-Sung;Lee, Chang-Ki;Han, Ik-Soo;Choi, Kwang-Sik
    • Archives of Pharmacal Research
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    • v.13 no.2
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    • pp.180-186
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    • 1990
  • A bioequivalence study of ranitidine tablets was conducted according to the Korean Guidine for the Bioequivalence Test using twelve healthy male subjects. The plasma concentration-timecurves of ranitidine from the test and reference tablets showed profound multiple peak phenomenon in each subject as reported earlier. However, the area under the plasma concentration-time curve (AUC) and the maximum ploasma concentration at the first peak ($C_{max1}$) of the two preparations was proven to be equal when analyzed satistically according to the criteria of the guidline;i. e., statistical power (1-$\beta$)was calculated to be over 0.8 under the condition of $\alpha$ = 5% and $\Delta$(minimum detectable difference) = 20%, and the confidence interval of the difference in AUC at 95% confidence level was in the range of $\pm$ 20%, which statisfied the criteria of bioequivalence. Equivalence of the peak concentration of ranitidine at the second peak ($C_{max2}$), and the time to reach the first ($T_{max1}$) and second verify the bioequivalence of $c_{max2}$ , $T_{max1}$ and $T_{max2}$ between the two tablets. However, we conclude that the test and reference tablets are bioequivalent taking the therapeutic characteristics of the ranitidine preparations into consideration.

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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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An implementation of automated ECG interpretation algorithm and system(IV) - diagnosis parameter extractor and classifier (심전도 자동 진단 알고리즘 및 장치 구현(V) - 진단 파라미터 추출 및 진단기)

  • Kweon, H.J.;Jeong, K.S.;Lee, J.W.;Shin, K.S.;Lee, M.H.
    • Proceedings of the KOSOMBE Conference
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    • v.1996 no.05
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    • pp.298-302
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    • 1996
  • The representative beat with high SNR could be obtained by the signal averaging, correct and fast detection of significant points and waveform boundary could be obtained by adoption of search interval. All experimental results of waveform boundary were compared with CSE database which had the 5 referees results and 11 ECG measurement programs. All results were within tolerance made by referees, especially the end point of T wave were more close to the referee's results than other 11 measurement programs. The diagnosis parameters that might be used in the Minnsota code criteria were extracted from the representative beat. The diagnostic classification were fulfilled using Minnsota code criteria. Through the comparison on the diagnosis results from designed automated ECG analyzer(YECGA) and the results ECG analyzer manufactured by Fukuda denshi(FCG-2201) in Japan, reliance of the performance on designed system(YECGA) could be validated.

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A meta-analysis of microbiota implicated in peri-implantitis

  • Han-gyoul Cho;Ran-Yi Jin;Seung-Ho Ohk
    • International Journal of Oral Biology
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    • v.48 no.3
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    • pp.19-31
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    • 2023
  • Peri-implantitis is a disease affecting the tissue surrounding dental implants, destroying both soft and hard tissues. A total of 2,015 studies were collected by searching items in the National Library of Medicine, including keywords, such as "peri-implantitis," "microbiota," and "microbiome." Of them, 62 studies were screened and considered eligible for analysis. Only 16 studies qualified all criteria mentioned here: "Using PCR methods for microorganism detection," "Suggesting quantified results," "Stating obvious clinical diagnosis criteria ("Bleeding on probing," "Probing pocket depth," "Suppuration," and "Radiographic bone loss")." Only 8 studies were included in the meta-analysis because the others had special issues. Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Aggregatibacter actinomycetemcomitans, Prevotella intermedia, and Epstein-Barr virus were the microbiological subjects of analysis. The odds ratio (OR) between the healthy implants and peri-implantitis were calculated for each microorganism to compare two groups, and the forest plots were suggested as the visual materials. P. gingivalis (1.392 < OR < 2.841), T. forsythia (1.345 < OR < 3.221), T. denticola (2.180 < OR < 5.150), A. actinomycetemcomitans (1.975 < OR < 6.456), P. intermedia (1.245 < OR < 3.612), and Epstein-Barr virus (1.995 < OR < 9.383). The species showed that their 95% confidence interval of odds ratio was higher than 1, indicating that they were detected more frequently in periimplantitis than in healthy implants. Meanwhile, other species, such as Fusobacterium nucleatum and Staphylococcus aureus, were not included in the meta-analysis because the number of studies was insufficient.

Proposal of Early-Warning Criteria for Highway Debris Flow Using Rainfall Frequency (1): Proposal of Rainfall Criteria (확률 강우량을 이용한 고속도로 토석류 조기경보기준 제안 (1) : 강우기준 제안)

  • Choi, Jaesoon
    • Journal of Korean Society of Disaster and Security
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    • v.12 no.2
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    • pp.1-13
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    • 2019
  • In this study, we propose rainfall frequency criteria for the development of early-warning system based on the evaluation of the highway debris flow that includes the contents of the rainfall recurrence cycle. The rainfall criterion was recommended based on the results of previous researches and the recommended rainfall criterion was 1 hour, 6 hours, and 3 days. At this time, the study subjects were located in Gangwon area and the probability rainfall of 8 stations in Gangwon area was collected. Also, the probabilistic distribution of the 1 hour, 6 hour, and 3 day rainfall criteria to be used for the early warning for the highway debris flow in Kangwon area was estimated through the probability analysis. In addition, we analyzed the correlation between 3 types of rainfall criteria selected from the rainfall data and the actual destructive damages of debris flow at 12 points in 7 lines of Gangwon highways. At this time, the rainfall criterion on the probability distribution was divided into an average value and a lower limit value. As a result of the review, it was found that the case of using the lower limit value of the rainfall according to the recurrence intervalwell simulates the situation of actual debris flow hazards.

Performance Evaluation Criterion of FTN-Based Transmission System (FTN 기반 전송 시스템의 성능 평가 기준에 관한 연구)

  • Kwak, Sangwoon;Yun, Joungil;Baek, Myungsun;Lim, Hyoungsoo
    • The Journal of Korean Institute of Communications and Information Sciences
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    • v.41 no.11
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    • pp.1645-1652
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    • 2016
  • FTN(Faster-Than-Nyquist) signaling is a method of transmitting symbols at rates faster than the Nyquist rate in the same bandwidth by overlapping transmission pulses. The transmission power of the FTN signal is greater than that of the Nyquist signal, because the number of symbols in the FTN signal is larger than that in the Nyquist signal for the same time interval. Hence, to evaluate the performance of an FTN-based transmission system properly, the performance evaluation criterion should be carefully set, and conversion formulas among the criteria which are used in Nyquist-based system should also be applied attentively. In this paper, the performance evaluation criteria of the FTN-based transmission system is analyzed and a valid way to set the criteria is proposed.

Parametric Study on Steel composite Girder bridges for HONAM High-Speed Railway Considering Criteria Requirement of Dynamic Response (호남고속철도 동적 안정성 요구 조건을 고려한 강합성 거더교의 변수 연구)

  • Cho, Sun-Kyu;Jung, Han-Ouk;Kim, Sung-Il
    • Proceedings of the KSR Conference
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    • 2007.11a
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    • pp.1370-1378
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    • 2007
  • High speed railway bridge is affected on safety of bridge by dynamic amplification effect, when dynamic response of bridge is equal to effect cycle load for rolling stock axle according to high speed operation train. And excessive deformation of structure has negative effect on operation safety of train and comfort of passenger due to fluctuation of wheel load by torsion of track etc. and decrease of contact force on vehicle wheel-rail. To ensure the safety of track and train operation safety, it is have to perform the study on resonance and deformation of structure. That criteria and requirement of railway bridge is limitation of vertical acceleration on deck for dynamic behavior of structure, contact of vehicle wheel and rail, limitation of face distortion and rotation angle of end deck, and limitation of vertical displacement by train. Unlike KYEONGBU High Speed Railway, New constructed HONAM High Speed Railway have to applied the new requirement for dynamic behavior safety according to change of condition which is type of ballast (slab ballast), interval of track, and actual rolling stock load. Therefore, in this paper, it was conformed the dynamic characteristic due to parameter, which related with above mentioned criteria, for steel composite bridges.

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Analysis of the Influence of Track Alignment on Ride Comfort and Safety of KTX (방향틀림이 KTX 주행거동에 미치는 영향 분석)

  • Choi, Il-Yoon;Um, Ju-Hwan;Kim, Man-Cheol
    • Journal of the Korean Society for Railway
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    • v.16 no.2
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    • pp.110-116
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    • 2013
  • Track irregularities is one of the key factors influencing the running behavior of trains. In order to ensure safety and ride comfort of train, the criteria for track irregularities should be adequately established regarding vehicle velocity, vehicle characteristics, characteristics of the track recording car, and measurement interval. Also, track maintenance should be carried out thoroughly according to the criteria for managing track irregularities. Numerical analysis was conducted to investigate the influence of track alignment on the running behavior of Korean high speed train(KTX). Various wavelengths and amplitudes of lateral alignment were considered as parameters for this study using the Vampire program, a vehicle dynamics modeling package in railway environment. Derailment, lateral load, bogie acceleration and body acceleration of numerical analysis results due to alignment were investigated. Finally, the influence of the alignment on safety and ride comfort for the KTX was evaluated. This study indicates that alignment irregularities have significant impacts on running safety, and that the criteria used to manage alignment irregularities should be restrictive to ensure the running safety of the KTX.

Ovarian volume is more closely related to the different manifestations of polycystic ovary syndrome than follicle number per ovary

  • Shazia Afrine;Jasmine Ara Haque;Md Shahed Morshed;Hurjahan Banu;Ahmed Hossain;Muhammad Abul Hasanat
    • Clinical and Experimental Reproductive Medicine
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    • v.50 no.3
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    • pp.200-205
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    • 2023
  • Objective: Polycystic ovary (PCO), a diagnostic component of polycystic ovary syndrome (PCOS), requires either an ovarian volume (OV) criterion or a follicle number per ovary (FNPO) criterion. This study investigated the association of OV and FNPO criteria with various manifestations of PCOS. Methods: This cross-sectional study was conducted at a university hospital among 100 patients newly diagnosed with PCOS (according to the revised Rotterdam criteria). Fasting blood samples were collected to measure glucose, total testosterone (TT), luteinizing hormone (LH), follicle-stimulating hormone (FSH), lipid, insulin, and hemoglobin A1c levels. An oral glucose tolerance test was performed. Transabdominal or transvaginal ultrasound of the ovaries was done, depending on patients' marital status. All investigations were conducted in the follicular phase of the menstrual cycle. OV >10 mL and/or FNPO ≥12 indicated PCO. A homeostasis model assessment of insulin resistance (IR) value ≥2.6 indicated IR, and metabolic syndrome (MS) was defined according to the international harmonization criteria. Results: Seventy-six participants fulfilled the OV criterion, 70 fulfilled the FNPO criterion, and 89 overall had PCO. Both maximum OV and mean OV had a significant correlation with TT levels (r=0.239, p=0.017 and r=0.280, p=0.005, respectively) and the LH/FSH ratio (r=0.212, p=0.034 and r=0.200, p=0.047, respectively). Mean OV also had a significant correlation with fasting insulin levels (r=0.210, p=0.036). Multivariate binary logistic regression analysis showed that IR (odds ratio [OR], 9.429; 95% confidence interval [CI], 1.701 to 52.271; p=0.010) and MS (OR, 7.952; 95% CI, 1.821 to 34.731; p=0.006) had significant predictive associations with OV alone, even after adjustment for age and body mass index. Conclusion: OV may be more closely related to the androgenic and metabolic characteristics of PCOS than FNPO.

Prediction of lifespan and assessing risk factors of large-sample implant prostheses: a multicenter study

  • Jeong Hoon Kim;Joon-Ho Yoon;Hae-In Jeon;Dong-Wook Kim;Young-Bum Park;Namsik Oh
    • The Journal of Advanced Prosthodontics
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    • v.16 no.3
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    • pp.151-162
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    • 2024
  • PURPOSE. This study aimed to analyze factors influencing the success and failure of implant prostheses and to estimate the lifespan of prostheses using standardized evaluation criteria. An online survey platform was utilized to efficiently gather large samples from multiple institutions. MATERIALS AND METHODS. During the one-year period, patients visiting 16 institutions were assessed using standardized evaluation criteria (KAP criteria). Data from these institutions were collected through an online platform, and various statistical analyses were conducted. Risk factors were assessed using both the Cox proportional hazard model and Cox regression analysis. Survival analysis was conducted using Kaplan-Meier analysis and nomogram, and lifespan prediction was performed using principal component analysis. RESULTS. The number of patients involved in this study was 485, with a total of 841 prostheses evaluated. The median survival was estimated to be 16 years with a 95% confidence interval. Factors found to be significantly associated with implant prosthesis failure, characterized by higher hazard ratios, included the 'type of clinic', 'type of antagonist', and 'plaque index'. The lifespan of implant prostheses that did not fail was estimated to exceed the projected lifespan by approximately 1.34 years. CONCLUSION. To ensure the success of implant prostheses, maintaining good oral hygiene is crucial. The estimated lifespan of implant prostheses is often underestimated by approximately 1.34 years. Furthermore, standardized form, online platform, and visualization tool, such as nomogram, can be effectively utilized in future follow-up studies.