• Title/Summary/Keyword: Specification-based Test

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Development of Dissolution Test for Itopride Hydrochloride Tablets and Tiropramide Hydrochloride Tablets (이토프리드염산염 정과 티로프라미드염산염 정의 용출시험법 개발)

  • Kim, Jung Hyun;Lee, Jong Hwa;Choi, Lan;Choi, Yeon Hee;Lee, Jong Chul;An, Ji Hye;Lee, Gwang Moon;Shim, Young Hoon;Kang, Shin-Jung;Sah, Hong-Kee;Choi, Hoo-Kyun;Kim, In-Kyu
    • YAKHAK HOEJI
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    • v.57 no.3
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    • pp.205-212
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    • 2013
  • Dissolution test has been performed to control drug quality and to predict in vivo drug release profile of solid dosage forms, so there's a drift towards setting dissolution test instead of disintegration test. However, some solid dosage forms in Korea Pharmaceutical Codex (KPC) are not established the dissolution test yet, so these monographs are necessary to set the specification of dissolution test. In this study, we developed the specification and test method of dissolution test for itopride hydrochloride tablets and tiropramide hydrochloride tablets which are not established the dissolution test yet. According to the "Manual for Guideline Application for Validation of Analytical Procedures" and "Guidelines on Specification of Dissolution test for Oral dosage form" of Korean Pharmacopoeia (KP), we validated and established each development method. Based on the preliminary dissolution profile, we set the dissolution condition(paddle apparatus, pH 1.2 media, 50 rpm). For this condition, we performed the main dissolution test to determine the specification (45 min, 85%). Finally, we validated each analytical method by specificity, linearity, accuracy and precision. These developed methods will be included the next supplement of KPC and also contributed to the quality control of medicines.

Development of Dissolution Test Method for Acebrophylline Capsules and Bromhexine Hydrochloride Tablets in Korean Pharmaceutical Codex (고시수재 의약품 중 아세브로필린 캡슐 및 브롬헥신염산염 정의 용출시험법 개발)

  • Lee, Tae-Woong;Jeong, Rae-Seok;Jeong, Seung-A;Kim, Jeong-Hyun;Shim, Young-Hun;Kim, In-Kyu;Park, Chang-Won
    • YAKHAK HOEJI
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    • v.57 no.3
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    • pp.226-233
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    • 2013
  • Although the dissolution test can serve as an effective tool for quality control and predictor of in vivo performance, there are a number of drugs with no established dissolution specification in Korean Pharmaceutical Codex (KPC). So, with each reference and test drugs, the dissolution test method and an analytical procedure by HPLC were developed and validated to establish dissolution specification for acebrophylline capsules and bromhexine hydrochloride tablets. The dissolution condition was determined based on the "Guidelines on Specifications of Dissolution tests for Oral dosage forms" of Ministry of Food and Drug Safety (MFDS). The analytical method of HPLC was validated in specificity, linearity, precision and accuracy. Final dissolution test was performed with commercially available samples of 3 lots to establish specification. In addition, no difference was observed by the inter-laboratory evaluation. Dissolution specifications and conditions will be used for revising the monograph of acebrophylline capsules and bromhexine hydrochloride tablets in next supplement of KPC.

Effect of Engine Specification and Driving Conditions on the Idle Emission Characteristics of SI Vehicles (Sl 자동차의 아이들 운전시 엔진 및 운행 조건에 따른 배출 가스 특성)

  • 류재욱;송정훈;이창식
    • Transactions of the Korean Society of Automotive Engineers
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    • v.10 no.3
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    • pp.70-76
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    • 2002
  • This study focus on the effect of engine specification, driving conditions and the vehicle type on the idle emission characteristics. In order to obtain the characteristics of exhaust emissions, 1,260 vehicles of spark ignition engine are sampled and investigated. The exhaust emissions are measured with a CO/HC emission gas analyzer. The Sl engine vehicles are investigated by the effect of various exhaust emission parameters such as vehicle milage, engine specification, valve trains and fuels. The results show that the amount of CO and HC emission is not directly related to the driving mileage of the vehicle. However, the engine specifications and fuels such as the type of valve train and piston displacement have influence on the exhaust emissions. In addition, the LPG vehicle emits more CO and HC than gasoline vehicle. Based on the test results of SI vehicles, the influence of excess air and displacement volume are discussed.

A Study on the Automated Compatibility Standard Test System for eBook DRM (전자책 DRM을 위한 자동화된 표준정합성 검사 시스템에 관한 연구)

  • Kim, Tae-Hyun;Kang, Ho-Gap;Ahn, Chang-Ju;Cho, Seong-Hwan
    • The Journal of the Institute of Internet, Broadcasting and Communication
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    • v.13 no.2
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    • pp.127-136
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    • 2013
  • The study of the compatibility of EPUB DRM, granted by the Korea Copyright Commission, as a CT R & D project (Project Title: The Development of the standard reference software technology for International Standard EPUB-based eBook DRM) developed standards such as profile standards for encryption digital signature and authentication certificates and standards for technical terms of rights information. In 2012, these four standards have been established as the Korean Industrial Standards under the names of 'Encryption specification for EPUB DRM,' 'the Digital signature specification for EPUB DRM,' 'the Certificate specification for EPUB DRM,' and 'Definitions of Right Terms for EPUB DRM' through the ODPF(Open Digital Standardization Forum) and the TTA(Telecommunications Technology Association). The research project also proposed standards of ebook DRM license protocols in order for the four standards to practically apply to ebook DRM compatibility. It is necessary for technology standards to require a compatibility standard test process for testing whether implementations which were developed on the basis of the standard specification, comply with standards. This study suggests an automated compatible standard test method and a test model under the ebook DRM standard technical specification.

Implementation of PXIe platform based portable Automatic Test Equipment to improve reliability

  • Gwon, Hyeok-Jin
    • Journal of the Korea Society of Computer and Information
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    • v.22 no.7
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    • pp.9-16
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    • 2017
  • In this paper, we propose a development method of portable Automatic Test Equipment based on PXIe platform. Legacy VME form factor structured test equipment has limited reuse and expansion of modules due to unapplied bus specification. In particular, these limitations can cause development periods and costs to increase, and the reliability of environmental conditions is lacking due to non-standard modules. The test equipment of the proposed PXIe platform can use diverse COTS modules to shorten the development period and minimize the instability between developments. The PXIe development module works with standard Xilinx FPGAs, PXIe Windows device drivers, and applications on standard PXIe buses. The use of standard bus and COTS modules increases scalability and reusability, enabling rapid development and excellent maintenance. Through the test, we show the proposed test equipments can be implemented efficiently between the development processes and proved their reliability through function tests and environmental tests.

Model-based Test Cases Generation Method for Weapons System Software (무기체계 소프트웨어의 모델 기반 테스트 케이스 생성 방법)

  • Choi, Hyunjae;Lee, Youngwoo;Baek, Jisun;Kim, Donghwan;Cho, Kyutae;Chae, Heungseok
    • Journal of the Korea Institute of Military Science and Technology
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    • v.23 no.4
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    • pp.389-398
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    • 2020
  • Test cases in the existing weapon system software were created manually by the tester analyzing the test items defined in the software integration test procedure. However, existing test case generation method has two limitations. First, the quality of test cases can vary depending on the tester's ability to analyze the test items. Second, excessive time and cost may be incurred in writing test cases. This paper proposes a method to automatically generate test cases based on the requirements model and specifications to overcome the limitations of the existing weapon system software test case generation. Generate test sequences and test data based on the use case event model, a model representing the requirements of the weapon system software, and the use case specification specifying the requirements. The proposed method was applied to 8 target models constituting the avionics control system, producing 30 test sequences and 8 test data.

Study of Vibration Test Condition for Machinery Component (기계류부품의 가진시험 조건에 관한 연구)

  • Kim Hyoung-Eui;Park Jong-Won;Jung Dong-Soo;Kang Bo-Sik
    • Journal of Applied Reliability
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    • v.6 no.1
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    • pp.27-36
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    • 2006
  • It is increasingly important to ensure that a given vibration test specification of a particular machinery component is appropriately established by considering its real environmental conditions. Vibration test standards for electrical components are well documented, for example in an IEC 60068 series, while standards for machinery components are rarely found except a few military standards. Thus many vibration tests are performed based on the military standards. However, a test based on these military standards often results in over-testing, and under-testing in some cases due to the different environmental conditions. Also, these standards require an appropriate tailoring that may not be easily accomplished. In this paper, various international and military standards are compared and investigated to obtain test specifications relevant for machinery components. Also appropriate tailoring methods are demonstrated through a case study.

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A Study of Flight Instructor Training Specification for MPL (Multi-Crew Pilot License) in Korea (부조종사 자격증명(MPL; Multi-Crew Pilot License) 비행교관 훈련프로그램에 관한 연구)

  • Kim, Kyeong Tae;Kim, Jinwook;Kang, Keumseok
    • Journal of the Korean Society for Aviation and Aeronautics
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    • v.30 no.2
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    • pp.61-69
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    • 2022
  • Since the MPL (Multi-Crew Pilot License) Program was introduced in Korea in 2009, there has not been a single pilot licensed under the MPL Program. To successfully implement the MPL Program in Korea, it is necessary for an Approved Training Organization to develop the MPL Flight Instructor Training Program and foster excellent MPL Flight Instructors. However, there are no rules or guidelines regarding the MPL Flight Instructor Training Program in Korea. This study suggests the Training Specification for the MPL Flight Instructor, including the training syllabus, training and assessment methods. The MPL Flight Instructor Training Program should be composed of minimum 14-hour academic and practical training, which includes the concept of Competency-Based Training, CRM, Competency, Behavior Indicator and Assessment. To be qualified for the MPL Flight Instructor, candidates need to successfully complete the course and pass the practical test. In order to maintain the qualification, MPL Flight Instructors should comply to recency and recurrent training requirements.

Conformance Test Scenario Extraction Techniques for Embedded Software using Test Execution Time (테스트 수행시간을 고려한 임베디드 소프트웨어의 적합성 테스트 시나리오 추출 기법)

  • Park, In-Su;Shin, Young-Sul;Ahn, Sung-Ho;Kim, Jin-Sam;Kim, Jae-Young;Lee, Woo-Jin
    • The KIPS Transactions:PartD
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    • v.17D no.2
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    • pp.147-156
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    • 2010
  • Conformance testing for embedded software is to check whether software was correctly implemented according to software specification or not. In conformance testing, test scenarios must be extracted to cover every test cases of software. In a general way, test scenarios simply focus on testing all functions at least one time. But, test scenarios are necessary to consider efficiency of test execution. In this paper, we propose a test scenario extraction method by considering function's execution time and waiting time for user interaction. A test model is a graph model which is generated from state machine diagram and test cases in software specification. The test model is augmented by describing test execution time and user interaction information. Based on the test model, test scenarios are extracted by a modified Dijkstra's algorithm. Our test scenario approach can reduce testing time and improve test automation.

A Conformance Test Procedure for the Enterprise JavaBeans (컴포넌트 소프트웨어를 위한 적합성 검증 방법)

  • Joo, Un-Gi;Kim, Joong-Bae
    • IE interfaces
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    • v.17 no.2
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    • pp.149-157
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    • 2004
  • This paper considers a conformity testing problem on EJB(Enterprise JavaBeans). The EJB architecture is a component architecture for the development and deployment of component-based distributed business applications. The objective is to find an optimal test sequence for the conformity test between the EJB specification and an implemented one. For the test sequence, we formulate the problem as a rural Chinese postman tour one and use a linear programming formulation. Based upon the formulations, we suggest a conformance test procedure and show its efficiency by applying the procedure to the CMP(Container- Managed persistency) entity bean of the EJB.