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" Design and analysis of bridging studies "
editors, Chin-Fu Hsiao, Jen-Pei Liu, Shein-Chung Chow.
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BL
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| Record Number
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751170
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b571129
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| Main Entry
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editors, Chin-Fu Hsiao, Jen-Pei Liu, Shein-Chung Chow.
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| Title & Author
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Design and analysis of bridging studies\ editors, Chin-Fu Hsiao, Jen-Pei Liu, Shein-Chung Chow.
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| Edition Statement
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Online-ausg
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| Publication Statement
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Boca Raton : Taylor & Francis, 2012
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| Series Statement
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Chapman & Hall
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| Page. NO
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(xviii, 263 Seiten) : Illustrationen.
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| ISBN
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1439846340
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: 1439846359
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: 9781439846346
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: 9781439846353
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| Contents
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Bridging Diversity: Extrapolating Foreign Data to a New Region, Shein-Chung Chow and Chin-Fu HsiaoIntroductionImpact of Ethnic DifferencesRegulatory GuidelinesCurrent IssuesExamplesConcluding RemarksAim and Structure of the BookTwo-Stage Designs of Bridging Studies, Chin-Fu Hsiao, Hsiao-Hui Tsou, Jen-pei Liu, and Yuh-Jenn WuIntroductionTwo-Stage Design for Bridging StudiesGroup Sequential Approach to Evaluating Bridging StudiesConcluding RemarksConsistency of Treatment Effects in Bridging Studies and Global Multiregional Trials, Weichung J. Shih and Hui QuanIntroductionGlobal Clinical TrialConsistency in Making Inference Regarding the Overall Treatment Effect Consistency as a Method for Region-Specific RegistrationOther ConsiderationsExampleDiscussionAssessing Similarity Using the Reproducibility and Generalizability Probabilities and the Sensitivity Index, Shein-Chung Chow, Ying Lu, and Lan-Yan YangIntroductionCriteria for Assessing SimilarityReproducibility and GeneralizabilityAssessing the Similarity-Based Sensitivity IndexConcluding RemarksCombining Information in Clinical Drug Development: Bridging Studies and Beyond, Kuang-Kuo Gordon Lan and Jose PinheiroIntroductionLeveraging Existing Information in Bridging StudiesApplication: Bridging of Blood Pressure DrugDiscussionA Bayesian Approach for Evaluation of Bridging Studies, Chin-Fu Hsiao, Hsiao-Hui Tsou, Jen-pei Liu, and Yuh-Jenn WuIntroductionMixture of Prior InformationDetermination of Sample SizeExamplesConcluding RemarksIssues of Sample Size in Bridging Trials and Global Clinical Trials, Hsien-Ming James Hung, Sue-Jane Wang, and Robert O'NeillIssues of Sample Size Planning for Bridging TrialIssues of Sample Size Planning in Global Clinical TrialImpacts of Consistency Assessment on Sample SizeDiscussionDesign and Sample Size Considerations for Global Trials, Christy Chuang-Stein, Yoichi Ii, Norisuke Kawai, Osamu Komiyama, and Kazuhiko KuribayashiIntroductionPoints to Consider When Designing a Multiregional TrialDetermination of Regional Sample Size in a Multiregional StudyAdditional Analysis to Estimate Treatment Effects in Different RegionsReal-Time Monitoring of Multiregional TrialsConcluding RemarksApplication of Genomic Technologies for Bridging Strategy Involving Different Race and Ethnicity in Pharmacogenomics Clinical Trials, Sue-Jane WangIntroductionPharmacogenomics and PharmacogeneticsBridgingBridging Study EvaluationChallenges of Bridging Strategy in PharmacogenomicsConcluding RemarksInteraction Effects in Bridging Studies, Eric Tsung-Cheng Hsieh and Jen-pei LiuIntroductionNoninferiority Hypothesis for Treatment SimilarityStatistical Testing ProceduresSimulation StudiesNumerical ExamplesDiscussion and Final RemarksMultiregional Clinical Trials, Yi Tsong and Hsiao-Hui TsouIntroductionDifferent Regional RequirementsBridging the Overall Treatment Effect to RegionsSummaryMultiregional Clinical Trials for Global Simultaneous Drug Development in Japan, Kihito Takahashi, Mari Ikuta, and Hiromu NakajimaIntroductionDrug LagMRCTs as a Solution to Drug LagImprovements in Clinical Trial Environment in JapanGrowing Trends of MRCTs in JapanMRCTs in the Field of OncologyMRCTs in the Field of CVMIssues in MRCTsFuture ProspectsFeasibility and Implementation of Bridging Studies in Taiwan, Mey Wang, Yeong-Liang Lin, and Herng-Der ChernOverviewRegulatory History of Bridging StrategyAssessment Experiences Based on ICH E5Bayesian Statistical Approach to Bridging StudiesDesigning an External (Supplemental) Bridging StudyConcluding RemarksIndexReferences appear at the end of each chapter.
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| Subject
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Biometry -- Methodology.
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| Subject
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Clinical trials -- Standards.
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| LC Classification
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RM301.27E358 2012
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| Added Entry
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Chin-Fu Hsiao
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Jen-pei Liu
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Shein-Chung Chow
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