• Title/Summary/Keyword: protocol testing

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Statistical implications of extrapolating the overall result to the target region in multi-regional clinical trials

  • Kang, Seung-Ho;Kim, Saemina
    • Communications for Statistical Applications and Methods
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    • v.25 no.4
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    • pp.341-354
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    • 2018
  • The one of the principles described in ICH E9 is that only results obtained from pre-specified statistical methods in a protocol are regarded as confirmatory evidence. However, in multi-regional clinical trials, even when results obtained from pre-specified statistical methods in protocol are significant, it does not guarantee that the test treatment is approved by regional regulatory agencies. In other words, there is no so-called global approval, and each regional regulatory agency makes its own decision in the face of the same set of data from a multi-regional clinical trial. Under this situation, there are two natural methods a regional regulatory agency can use to estimate the treatment effect in a particular region. The first method is to use the overall treatment estimate, which is to extrapolate the overall result to the region of interest. The second method is to use regional treatment estimate. If the treatment effect is completely identical across all regions, it is obvious that the overall treatment estimator is more efficient than the regional treatment estimator. However, it is not possible to confirm statistically that the treatment effect is completely identical in all regions. Furthermore, some magnitude of regional differences within the range of clinical relevance may naturally exist for various reasons due to, for instance, intrinsic and extrinsic factors. Nevertheless, if the magnitude of regional differences is relatively small, a conventional method to estimate the treatment effect in the region of interest is to extrapolate the overall result to that region. The purpose of this paper is to investigate the effects produced by this type of extrapolation via estimations, followed by hypothesis testing of the treatment effect in the region of interest. This paper is written from the viewpoint of regional regulatory agencies.

Development and Application of ATM Protocol Conformance Test System (ATM 프로토콜 적합성 시험시스템의 개발과 적용)

  • Gang, Seong-Won;Seo, Yeong-Su;Hong, Mi-Jeong;Yang, Jun-Hwan;Go, Il-Guk;Gang, Deuk-Yun;Yu, Sang-Jo;Lee, Chae-U;Kim, Myeong-Cheol
    • Journal of KIISE:Computing Practices and Letters
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    • v.5 no.4
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    • pp.498-506
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    • 1999
  • 본 논문에서는 ATM 통신프로토콜을 위한 자동시험시스템인 ACTS(ATM Conformance Test System)의 개발과 적용을 소개한다. ACTS는 ITU-T 또는 ATM Forum의 ATM 사용자-망 접속표준을 준용하는 ATM 단말과 망장비의 프로토콜적합성을 확인하는데 사용된다. 본 논문에서는 ACTS 개발에 사용된 방법을 소개한 뒤, ACTS를 실제 ATM 단말과 장비에 적용한 사례들을 소개한다. ACTS의 적용을 통하여 시험대상 장비들이 지닌 프로토콜구현상의 문제점을 파악하였고, 문제에 대한 원인분석을 수행하였다. 또한 이러한 문제점들이 상호운용에 미치는 장애를 예측함으로써, ACTS를 상호운용하는 ATM 장비를 확보하기 위한 유용한 도구로 사용할 수 있음을 보인다.Abstract This paper presents development and application of ACTS(ATM Conformance Test System), an automated test system for ATM protocols. ACTS is a test system that checks conformance of ATM terminal and network equipment implementing either ITU-T or ATM Forum user-network interface. This paper, after presenting the methodology and process used for developing ACTS, conducts case studies of its applications to real ATM equipment. By applying ACTS, we were able to detect numerous problems in protocol implementations of ATM equipment and analyse causes of the problems, thereby demonstrating the efficacy of ACTS as an efficient automated testing tool. Furthermore, by predicting the potential effects of the problems on interoperability, we show how ACTS can be used as a useful tool for ensuring interoperable ATM equipment.

A Heuristic Technique for Generating the Synchronizable and Optimized Conformance Test Sequences (최적화된 동기적 적합성시험 항목의 발견적 생성 방법)

  • Kim, Chul
    • The Journal of Korea Institute of Information, Electronics, and Communication Technology
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    • v.8 no.6
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    • pp.470-477
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    • 2015
  • This paper presents a new technique for generating an optimum synchronizable test sequence that can be applied in the distributed test architecture where both external synchronization and input/output operation costs are taken into consideration. The method defines a set of phases that constructs a tester-related digraph from a given finite state machine representation of a protocol specification such that a minimum cost tour of the digraph with intrinsically synchronizable transfer sequences can be used to generate an optimum synchronizable test sequence using synchronizable state identification sequences as the state recognition sequence for each state of the given finite state machine. This hybrid approach with a heuristic and optimization technique provides a simple and elegant solution to the synchronization problem that arises during the application of a predetermined test sequence in some protocol test architectures that utilize remote testers.

Development of Bluetooth Protocol Stack on Embedded System (임베디드 시스템 상에서 블루투스 프로토콜 스택 개발)

  • Lee, Sang-Hak;Chung, Tae-Choong
    • The KIPS Transactions:PartA
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    • v.11A no.2
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    • pp.123-128
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    • 2004
  • Recent advancement in RF technology and wireless communications has enabled the development of noble networks. Bluetooth that can be used in various application field is a kind of WPAN(Wireless Personal Area Network) standard that is widely known. Bluetooth enables voice and data applications to operate simultaneously. Various applications have been implemented based on standard Profiles. In this paper, we describes the development of Biuetooth network AP(Access Point) system for network connection of Bluetooth devices. Unlike headset, mouse, and keyboard, the access point should have capability to support multiple connection and stabilized network throughput. We have designed and developed the hardware system, core stack and profiles on embedded system to comply with standard specification. Our system showed compatibility and good protocol performance through testing with lots of products that is available in market.

A Sturdy on the Deployment Strategy of Communication Environment for Adopting the International Standards between ITS Center and Roadside Equipment (국제 표준에 부합하는 ITS 센터-노변장치간 통신환경 구축 방안 연구)

  • Lee, Sang-Hyun;Son, Seung-Neo;Cho, Yong-Sung;Lee, Choul-Ki
    • The Journal of The Korea Institute of Intelligent Transport Systems
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    • v.11 no.4
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    • pp.34-50
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    • 2012
  • This study set out to define a communication environment between an ITS center and field device required to be introduced in the nation in order to guarantee the interoperability, compatibility, and global competitiveness of communication between them in the nation. It also aimed to establish technical and policy plans for its introduction, develop an emulator for information exchange, and apply VMS by way of showing an example, thus testing its validity. First, a standard environment for information exchange between an ITS center and field device required to be introduced in the nation was defined as a dual protocol between DATEX and SNMP. The study also proposed a message definition system including meta-attribution definition and OID introduction. The study then suggested technical and policy plans for its introduction including securing enough feasibility with feedback through a model project of standard introduction, offering education and promotions for the standard in advance, providing methods to introduce and systematically manage OID, developing a hardware standard proper for the information exchange standard, and setting up an integrated management system to introduce a dual protocol.

Efficiency of occlusal and interproximal adjustments in CAD-CAM manufactured single implant crowns - cast-free vs 3D printed cast-based

  • Graf, Tobias;Guth, Jan-Frederik;Diegritz, Christian;Liebermann, Anja;Schweiger, Josef;Schubert, Oliver
    • The Journal of Advanced Prosthodontics
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    • v.13 no.6
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    • pp.351-360
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    • 2021
  • PURPOSE. The aim of this study was to evaluate the efficiency of occlusal and interproximal adjustments of single implant crowns (SIC), comparing a digital cast-free approach (CF) and a protocol using 3D printed casts (PC). MATERIALS AND METHODS. A titanium implant was inserted at position of lower right first molar in a typodont. The implant position was scanned using an intraoral scanner and SICs were fabricated accordingly. Ten crowns (CF; n = 10) were subject to a digital cast-free workflow without any labside occlusal and interproximal modifications. Ten other identical crowns (PC) were adjusted to 3D printed casts before delivery. All crowns were then adapted to the testing model, simulating chair-side adjustments during clinical placement. Adjustment time, quantity of adjustments, and contact relationship were assessed. Data were analyzed using SPSS software (P < .05). RESULTS. Median and interquartile range (IQR) of clinical adjustment time was 02:44 (IQR 00:45) minutes in group CF and 01:46 (IQR 00:21) minutes in group PC. Laboratory and clinical adjustment time in group PC was 04:25 (IQR 00:59) minutes in total. Mean and standard deviation (±SD) of root mean squared error (RMSE) of quantity of clinical adjustments was 45 ± 7 ㎛ in group CF and 34 ± 6 ㎛ in group PC. RMSE of total adjustments was 61 ± 11 ㎛ in group PC. Quality of occlusal contacts was better in group CF. CONCLUSION. Time effort for clinical adjustments was higher in the cast-free protocol, whereas quantity of modifications was lower, and the occlusal contact relationship was found more favourable.

A Study on Quality Control of Inorganic Acids using Ion Chromatograph (이온크로마토그래피를 활용한 무기산류 정도관리 방법 연구)

  • Park, Hae Dong;Park, Seung-Hyun;Jung, Kihyo
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.31 no.1
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    • pp.22-30
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    • 2021
  • Objectives: The objectives of this study were to develop a quality control protocol of inorganic acids using ion chromatograph and to evaluate analytical proficiency of the legally designated agencies. Methods: This study prepared inorganic acid samples by injecting three anion certified solutions (chloride, nitrate, and sulfate) on the quartz filters. To investigate the storage stability and concentration consistency of the samples, 240 samples for each anion were tested at weeks 0, 2, 4, 8, 12, and 16 while storing at 4℃ and 25℃. To evaluate analytical proficiency, two separate testings were administrated for six skilled analysts and 46 analysts affiliated with legally designated agencies. Results: Average recoveries of the three ions after 16 weeks of storage were fairly high (over 95%). In addition, average recoveries (chloride = 97%, nitrate = 96%, and sulfate = 103%) after 16 weeks of storage at low temperate were relatively higher than those (94%, 93%, and 98%) at room temperature. The coefficients of variation (CV) for the three ions were less than 5% except for the sulfate sample at 5.56 ㎍ (CV = 12.4%). The average ratios of the concentration values analyzed by the legally designated agencies to the injected concentrations were close to 1. However, their CVs were relatively greater (chloride ≤ 49%, nitrate ≤ 14%, and sulfate ≤ 28%), which implies a need for quality control. Conclusions: The quality control protocol used in this study for the three inorganic acids can be utilized in the quality control for ion chromatography.

Veterinary management protocol for non-human primates: quarantine, anesthesia, and postoperative care for mastoidectomy at animal research institutions

  • Yoon Beom Lee;Woori Jo;Eui-Suk Jeong;Tae Ku Kang;Gwang-Hoon Lee
    • Korean Journal of Veterinary Research
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    • v.63 no.4
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    • pp.35.1-35.10
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    • 2023
  • Non-human primate (NHP) research faces challenges due to zoonosis risk and complex veterinary management yet lacks standardized guidelines for animal care. Therefore, we developed an advanced veterinary management protocol for NHP quarantine, anesthesia, and postoperative care. Three female 4 to 5-year-old cynomolgus monkeys were anesthetized and underwent various tests, including body weight, temperature, blood tests, urinalysis, microbiological monitoring, and physical and dental examinations. Ivermectin and medicated baths were administered to eradicate ectoparasites and endoparasites, and testing was repeated 30 days later. Following quarantine, we performed computed tomography and anesthesia maintenance for mastoidectomy. To relieve pain and maintain body weight, we administered tramadol intramuscularly 4 times/day for 3 days and meloxicam subcutaneously twice daily for 14 days. Feed replacements were provided. During the 33-day quarantine period, physical examinations revealed no abnormalities indicative of infectious diseases, and no specific clinical symptoms were observed. Through a preliminary test of anesthesia time, we selected ketamine 4 mg/kg + medetomidine 50 ㎍/kg for short experiments such as computed tomography, and ketamine 8 mg/kg + medetomidine 50 ㎍/kg for intubation. Ten days after mastoidectomy, NHPs consumed 100 kcal/kg and recovered their body weight. This study offers advanced veterinary management guideline for NHP research. Such protocols can lead to more standardized and ethical practices in NHP research, thereby enhancing the quality of studies on NHPs and the translation of findings to human health and disease.

Effects of a relined fiberglass post with conventional and self-adhesive resin cement

  • Wilton Lima dos Santos Junior;Marina Rodrigues Santi;Rodrigo Barros Esteves Lins;Luis Roberto Marcondes Martins
    • Restorative Dentistry and Endodontics
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    • v.49 no.2
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    • pp.18.1-18.13
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    • 2024
  • Objectives: This study was conducted to evaluate the mechanical properties of relined and non-relined fiberglass posts when cemented to root canal dentin using a conventional dual-cure resin cement or a self-adhesive resin cement. Materials and Methods: Two types of resin cements were utilized: conventional and self-adhesive. Additionally, 2 cementation protocols were employed, involving relined and non-relined fiberglass posts. In total, 72 bovine incisors were cemented and subjected to push-out bond strength testing (n = 10) followed by failure mode analysis. The cross-sectional microhardness (n = 5) was assessed along the root canal, and interface analyses (n = 3) were conducted using scanning electron microscopy (SEM). Data from the push-out bond strength and cross-sectional microhardness tests were analyzed via 3-way analysis of variance and the Bonferroni post-hoc test (α= 0.05). Results: For non-relined fiberglass posts, conventional resin cement exhibited higher pushout bond strength than self-adhesive cement. Relined fiberglass posts yielded comparable results between the resin cements. Type II failure was the most common failure mode for both resin cements, regardless of cementation protocol. The use of relined fiberglass posts improved the cross-sectional microhardness values for both cements. SEM images revealed voids and bubbles in the incisors with non-relined fiberglass posts. Conclusions: Mechanical properties were impacted by the cementation protocol. Relined fiberglass posts presented the highest push-out bond strength and cross-sectional microhardness values, regardless of the resin cement used (conventional dual-cure or self-adhesive). Conversely, for non-relined fiberglass posts, the conventional dual-cure resin cement yielded superior results to the self-adhesive resin cement.

Predictions of VO2max Using Metabolical Responses in Submaximal Exercise and 1,200 m Running for Male, and the Validity of These Prediction Models (성인 남성의 최대하 운동시 대사반응 및 1,200 m 달리기 기록을 이용한 최대산소섭취량 추정식 개발 및 타당도)

  • Im, J.H.;Jeon, Y.J.;Jang, H.K.;Kim, H.J.;Kim, K.H.;Lee, B.K.
    • Exercise Science
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    • v.21 no.2
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    • pp.231-242
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    • 2012
  • The purpose of this study was to develop the prediction model of VO2max using submaximal metabolic responses from the Bruce protocol, HR responses at several stages and 1,200 m running record, and to compare and analyse the validity of these prediction models. The subjects were consisted of 255 male(133 male for 1,200 m running). They were participated maximal exercise testing with Bruce protocol, and the metabolic responses were measured in the end of the first(3 minute), second stage(6 minute), and 1,200 m running record. Measurement items were VO2(㎖/kg/min), VCO2(㎖/kg/min), VE(L/min), HR(bpm) of 3 and 6 minute, time to HR 150 bpm and 170 bpm, HR difference between Bruce protocol 6 and 3 minute, 1,200 m running record. Analyzing with all variables using enter method, the multiple R of total variable model was 0.642(p<.01), SEE was 4.38 ㎖/kg/min, CV was 10.8 %, but multicolinearity was appeared. The multiple R of 3 minutes model 1 and model 2 were 0.341 and 0.461, SEE was 6.05 and 5.72 ㎖/kg/min, CV was 14.9 and 14.1%, and multicolinearity did not appeared. The multiple R of 6 minutes model 1 and model 2 were 0.350 and 0.456, SEE was 6.03 and 5.74 ㎖/kg/min, CV was 14.9 and 14.2%, and multicolinearity did not appeared. The R of HR 170 and HR 170 model were 0.151 and 0.154, SEE were 6.36~6.37 ㎖/kg/min, CV were 15.7%. The R of 1,200 m running model was 0.444, SEE was 4.82 ㎖/kg/min, CV were 11.9%. In conclusion, with considering usefulness and convenience through the validity of these prediction models, the prediction model of VO2max recommended 6 and 3 minute model, and the validity of HR model and 1,200 m running model were moderately low.