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Statistical Methods in Biomarker and Early Clinical Development

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概要 This contributed volume offers a much-needed overview of the statistical methods in early clinical drug and biomarker development. Chapters are written by expert statisticians with extensive experienc...e in the pharmaceutical industry and regulatory agencies. Because of this, the data presented is often accompanied by real world case studies, which will help make examples more tangible for readers. The many applications of statistics in drug development are covered in detail, making this volume a must-have reference. Biomarker development and early clinical development are the two critical areas on which the book focuses. By having the two sections of the book dedicated to each of these topics, readers will have a more complete understanding of how applying statistical methods to early drug development can help identify the right drug for the right patient at the right dose. Also presented are exciting applications of machine learning and statistical modeling, along with innovative methods and state-of-the-art advances, making this a timely and practical resource. This volume is ideal for statisticians, researchers, and professionals interested in pharmaceutical research and development. Readers should be familiar with the fundamentals of statistics and clinical trials.続きを見る
目次 Predictive Subgroup/Biomarker Identification and Machine Learning Methods
Characterize and Dichotomize a Continuous Biomarker
Surrogate Biomarkers
Innovative Designs for Biomarker Guided Trials
Statistical Considerations in the Development of Companion Diagnostic Device
Biomarker Assay Development, Qualification and Validation
Validation of Genomic Based Assay
Clinical Application of Molecular Features in Therapeutic Selection and Drug Development
Big data, real-world data, and machine learning
Design and Analysis of Clinical Pharmacology Studies
Statistical Considerations in Proof of Concept Studies
Safety in Early Phase Studies
Statistical Evaluation of QT/QTc Interval Prolongation
Phase II Dose Finding
Pharmacometrics.
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本文を見る Full text available from Springer Mathematics and Statistics eBooks 2019 English/International

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登録日 2020.06.27
更新日 2020.06.28