• Title/Summary/Keyword: Endpoints

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A Study on the Decision Making Procedure of Clean-up Endpoints for Oiled Shorelines in Korea (우리나라 해안오염 방제종료 의사결정절차의 고찰)

  • Kim, Dong-Geun;Jeon, Hae-Jong;Kim, Jae-Dong
    • Journal of Fisheries and Marine Sciences Education
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    • v.24 no.5
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    • pp.712-720
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    • 2012
  • Recently, many problems related on shoreline response to spill oil were exposed again on a occasion of M/T Hebei spirit accident even though the weakness on the shoreline response system has been brought up since M/T Sea Prince oil spill accident. Therefore the establishment of shoreline response system that best suits our country is needed through considering the response system of well-developed country. The socioeconomic conflict between the persons concerned on the clean-up endpoints can be sharpened in Korea because the frequency of coastal use of our country is too high compared to other countries. Thus procedural justification, that is, how the clean-up endpoints be established is more important than what type of clean-up endpoints be used. In the present paper, we attempted to suggest a new manner on the decision making system for clean-up endpoints that best suits our country. The decision making system for clean-up endpoints need to be divided into two steps, that is, set-up step of clean-up endpoints criteria and decision step of clean-up endpoints. The decision making organization of local governments play a key role in case of set-up step of clean-up endpoints criteria, while the response command headquarters under Korean coast guard and decision making organization of local governments codecide whether the clean-up endpoints criteria is fits or not.

The Role and Application of Biomarkers and Surrogate Endpoints for New Drug Development : Focused on Diabetes Mellitus and Osteoporosis (당뇨병 및 골다공증 치료제의 효율적인 신약개발을 위한 생체표지자 및 대리 결과 변수의 역할 및 활용)

  • Seong, Soo-Hyeon;Yun, Hwi-Yeol;Baek, In-Hwan;Kang, Won-Ku;Chang, Jung-Yun;Seo, Kyung-Won;Kwon, Kwang-Il
    • YAKHAK HOEJI
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    • v.52 no.5
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    • pp.331-344
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    • 2008
  • Recently, the FDA (Food and Drug Administration) of the United States and many advanced countries remark biomarkers and surrogate endpoints as a critical path tool on model based drug development. Economic, technical and social profit on model based drug development like a reduction of the length of research and development have been achieved. Therefore we summarize previous studies about biomarkers and surrogate endpoints and suggest a development direction of therapeutic agents. In diabetes mellitus (DM) and osteoporosis, there are remarkable increases in number of patients and most of patients take medicine during their whole lifetime. For this reason, many patients with DM and osteoporosis have a tolerance on their medicine. We expect that research and development on biomarkers and surrogate endpoints will contribute to new drug development on DM and osteoporosis. Biomarkers for DM are blood levels of glucose, insulin, ${HbA}_{1c}$, CRP, alpha-glucosidase, adiponectin and DPP-4. Among these, validated surrogate endpoints for DM are blood levels of glucose, insulin and ${HbA}_{1c}$ Biomarkers for osteoporosis are BMD, BMC, trabecular volume, ICTP, DPD, osteocalcin, the activity of osteoclast and production of osteoblast. The validated surrogate endpoints for osteoporosis are BMD only. This review summarizes all suggested biomarkers and surrogate endpoints in DM and osteoporosis. The biomarkers are classified by drugs, and the method of validation for surrogate endpoints is suggested. This information would contribute to suggest a direction of DM and osteoporosis therapeutic agent development.

Statistical tests for biosimilarity based on relative distance between follow-on biologics for ordinal endpoints

  • Yoo, Myung Soo;Kim, Donguk
    • Communications for Statistical Applications and Methods
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    • v.27 no.1
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    • pp.1-14
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    • 2020
  • Investigations of biosimilarity between reference drugs and test drugs required statistical tests; in addition, statistical tests to evaluate biosimilarity have been recently proposed. Ordinal outcome data has been observed in research; however, appropriate statistical tests to deal with ordinal endpoints for biosimilar have not yet been proposed. This paper extends existing design for ordinal endpoints. Using measure of nominal-ordinal association and relative distances between drugs are defined so that testing procedures are developed. Through simulation studies, we investigate type I error rate and power to show the performance of our suggested method. Furthermore, a comparison between the statistical tests and other designs is proviede to show significance of ordinal endpoints.

Sample Size Calculations for the Development of Biosimilar Products Based on Binary Endpoints

  • Kang, Seung-Ho;Jung, Ji-Yong;Baik, Seon-Hye
    • Communications for Statistical Applications and Methods
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    • v.22 no.4
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    • pp.389-399
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    • 2015
  • It is important not to overcalculate sample sizes for clinical trials due to economic, ethical, and scientific reasons. Kang and Kim (2014) investigated the accuracy of a well-known sample size calculation formula based on the approximate power for continuous endpoints in equivalence trials, which has been widely used for Development of Biosimilar Products. They concluded that this formula is overly conservative and that sample size should be calculated based on an exact power. This paper extends these results to binary endpoints for three popular metrics: the risk difference, the log of the relative risk, and the log of the odds ratio. We conclude that the sample size formulae based on the approximate power for binary endpoints in equivalence trials are overly conservative. In many cases, sample sizes to achieve 80% power based on approximate powers have 90% exact power. We propose that sample size should be computed numerically based on the exact power.

A Speech Recognition System based on a New Endpoint Estimation Method jointly using Audio/Video Informations (음성/영상 정보를 이용한 새로운 끝점추정 방식에 기반을 둔 음성인식 시스템)

  • 이동근;김성준;계영철
    • Journal of Broadcast Engineering
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    • v.8 no.2
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    • pp.198-203
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    • 2003
  • We develop the method of estimating the endpoints of speech by jointly using the lip motion (visual speech) and speech being included in multimedia data and then propose a new speech recognition system (SRS) based on that method. The endpoints of noisy speech are estimated as follows : For each test word, two kinds of endpoints are detected from visual speech and clean speech, respectively Their difference is made and then added to the endpoints of visual speech to estimate those for noisy speech. This estimation method for endpoints (i.e. speech interval) is applied to form a new SRS. The SRS differs from the convention alone in that each word model in the recognizer is provided an interval of speech not Identical but estimated respectively for the corresponding word. Simulation results show that the proposed method enables the endpoints to be accurately estimated regardless of the amount of noise and consequently achieves 8 o/o improvement in recognition rate.

Performance Analysis of TNS System for Improving DDS Discovery (DDS 검색 방식 개선을 위한 TNS 시스템 성능 분석)

  • Yoon, Gunjae;Choi, Jeonghyun;Choi, Hoon
    • The Journal of Korean Institute of Next Generation Computing
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    • v.14 no.6
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    • pp.75-86
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    • 2018
  • The DDS (Data Distribution Service) specification defines a discovery method for finding participants and endpoints in a DDS network. The standard discovery mechanism uses the multicast protocol and finds all the endpoints in the network. Because of using multicasting, discovery may fail in a network with different segments. Other problems include that memory space wastes due to storing information of all the endpoints. The Topic Name Service (TNS) solves these problems by unicasting only the endpoints, which are required for communication. However, an extra delay time is inevitable in components of TNS, i.e, a front-end server, topic name servers, and a terminal server. In this paper, we analyze the performance of TNS. Delay times in the servers of TNS and time required to receive endpoint information are measured. Time to finish discovery and number of receiving endpoints compare with the standard discovery method.

Methods of Combining P-values for Multiple Endpoints of Various Data Types (제 3상 임상시험에서 여러 형태 반응변수의 다변량 검정법인 P값 병합법)

  • Kim, Su-Young;Song, Hae-Hiang
    • The Korean Journal of Applied Statistics
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    • v.21 no.1
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    • pp.35-51
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    • 2008
  • Comparative studies in Phase III clinical trials quite often involve two or more equally important endpoints, and one cannot select primary endpoint from them. O'Brien(1984) proposed for continuous endpoints the OLS and GLS statistics as milti-variate test statistics. Pocock et al. (1987) mentioned the possibility of analyzing a mixture of data types, such as quantitative, binary and survival data types, with the OLS and GLS statistics, but the authors did not explore problems in combining several endpoints of different types. Furthermore, they did not perform a simulation study to assess the efficiencies of the OLS and GLS statistics for endpoints of a mixture of data types. In this paper, we propose the combining methods of correlated P-values for the analysis of multiple endpoints, and compare the efficiencies of this method with those of OLS and GLS statistics for a mixture of data types with a simulation study. Among the several methods of combining P-values that are more advantageous than combining of OLS and GLS statistics, method B maintains nominal significance levels and is more efficient, while method F and G have type I error rates that are larger than the specified significance levels, which might occasionally lead to a wrong conclusion.

Adaptive Packet Transmission Scheme for Exchanging Information between Endpoints in DDS Middleware (DDS 미들웨어에서 단말개체 간 정보교환을 위한 적응형 패킷 전송 기법)

  • Ahn, Sung-Woo
    • Proceedings of the Korean Institute of Information and Commucation Sciences Conference
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    • 2012.05a
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    • pp.110-113
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    • 2012
  • DDS middleware transmits data packets through unicast or multicast method for discovering endpoints on a distributed network and exchanging information between endpoints. Depending on the communicating situation between endpoints, the transmission method which is used to exchange packets is already defined by the standard protocol. However, the predefined usage of the transmission method has a problem that the middleware does not deal with increasing usage of the system resources properly when the configuration of endpoint is changed dynamically. To solve this problem, we propose the scheme of selecting the packet transmission method in an adaptive manner.

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Repeatability of Monocular Spherical Endpoints Test (단안 구면 끝점검사의 반복성 검증)

  • Kim, Sang-Yeob;Moon, Byeong-Yeon;Cho, Hyun Gug
    • Journal of Korean Ophthalmic Optics Society
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    • v.17 no.2
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    • pp.209-213
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    • 2012
  • Purpose: To assess the repeatability of the monocular spherical endpoints, a test was performed with four methods which are the retinoscopy, the MPMVA (maximum plus maximum visual acuity) method, the R/G duochrome method, and the crossed cylinder method. Methods: The monocular spherical endpoints was measured by four kinds of method (Retinoscopy, MPMVA method, R/G duochrome method, Crossed cylinder method) on 20 subjects (40 eyes) of average age 23.0 year-old men and women. After a week, retest was performed by same procedure and the test-retest repeatability was assessed by using the Bland-Altman plot analysis. Results: The test-retest mean difference of retinoscopy was the smallest diopters of -0.03 and that of R/G duochrome method was the largest diopters of -0.19. The upper/lower 95% limits of agreement for repeatability was the narrowest in retinoscopy and was the widest in crossed cylinder method. When compared the spherical endpoints of each eye between by retinoscopy and by other three methods, the error rate of ${\pm}0.25D$ in total eyes was 85% in MPMVA method, 80% in R/G duochrome method, and 24% in crossed cylinder method. Conclusions: Test-retest repeatability is the highest in the retinoscopy, and the retinoscopy, the MPMVA method, and R/G duochrome method are suitable for monocular spherical endpoints test.

Study on Development of Assessment Guideline and Endpoints for Clinical Trial with Antitumor Natural Products (천연물 항암제제 임상시험 평가지표 개발연구)

  • Namgung, Mi-Ae;Chang, Yoo-Sung;Jeong, Seung-Gi;Kim, Jin-Seung;Yoon, Sung-Woo;Jang, Ki-Young;Yoo, Hwa-Seung;Jung, Myeon-Woo;Lee, Sung-Ho;Kim, Sung-Hoon
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.20 no.6
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    • pp.1678-1727
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    • 2006
  • This study was perfromed to develop the assessment guideline and endpoints for clinical trial with anticancer herbal medicine. The botanical products used to humans for long time may be applied to phase 3 clinical trial after submitting the evidences for safety and efficacy of them or completion of basic requirement of phase 1 and phase 2 for safety confirmation and dose determination. Syndrome improvement was chiefly evaluated by Zubrod and karnofsky(%) methods. We suggest the general clinical trial assessment with botanical products, by following assessment points, that is, tumor size for 50 points, survival fate for 10 points, major syndromes for 40 points. It is recommendable that the each symptom of Qi deficiency syndrome, blood deficiency syndrome and Qi stagnation syndrome was allocated by assessment points, Similarly, the each symptom was given the assessment points according to the severity of symptom, for example, slight for 3 points, moderate for 2 points and severe for 1 point in hepatocelluar carcinoma and lung cancer. Then, the efficacy of botanical products was evaluated by the difference between pre-treatment and post-treatment. Asking the neoplastic patients of questionnaire on physical, emotional, cognitive, social and role subjects availability, three more syndromes (Fatigue, Pain and Nausea/Vomit), quality of life(QOL) will be evaluated by GLM statistics. In addition, in case of lung cancer, 13 questions will be asked by the EORTC QLQ-C13 forms. As the assessment of endpoints for efficacy to reduce side effects induced by chemotherapy and radiotherapy, the data of image scanning and hemato-urinalysis can be usefully applied on immune response, weight loss, indigestion, hemopoietic damage and injury of liver and kidney, while the changes of syndromes of side effect can be evaluated by differentiation methods of Qi and blood and five viscera. However, it is still necessary to determine the ratio between scientific analytical method and Oriental differentiation method as well as confirm the Oriental assessment endpoints by clinical trial. In addition, we suggest the continuous development of assessment endpoints on other carcinomas except of hepatocelluar carcinoma and lung cancer in future.