Statistical Methods in Biomarker and Early Clinical Development

Edited by Liang Fang () and Cheng Su ()

in Springer Books from Springer

Date: 2019
ISBN: 978-3-030-31503-0
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Chapters in this book:

Predictive Subgroup/Biomarker Identification and Machine Learning Methods

M. Man, T. S. Nguyen, C. Battioui and G. Mi

Characterize and Dichotomize a Continuous Biomarker

G. Mi, W. Li and T. S. Nguyen

Surrogate Biomarkers

Yongming Qu

Innovative Designs for Biomarker-Guided Trials

Jing Wang and Mark Chang

Statistical Considerations in the Development of Companion Diagnostic Device

Meijuan Li and Rui Tang

Biomarker Assay Development, Qualification, and Validation

Guang Chen, Shuguang Huang, Winnie Weng and Cheng Su

Validation of Genomic-Based Assay

Yoonha Choi and Jing Huang

Clinical Application of Molecular Features in Therapeutic Selection and Drug Development

Ruixiao Lu, Rui Tang and Jing Huang

Big Data, Real-World Data, and Machine Learning

Jing Lu, Yangyang Hao, Jing Huang and Su Yeon Kim

Design and Analysis of Clinical Pharmacology Studies

Winnie Weng and Liang Fang

Statistical Considerations in Proof-of-Concept Studies

Laurence Colin and Brian Smith

Safety in Early Phase Studies

Laurence Colin and Brian Smith

Statistical Evaluation of QT/QTc Interval Prolongation

Liang Fang, Winnie Weng, Lu Wang and Xiaoru Wu

Phase II Dose Finding

Qiqi Deng and Naitee Ting

Pharmacometrics

Alan H. Hartford and Kenneth G. Kowalski

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DOI: 10.1007/978-3-030-31503-0

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