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Statistical Methods in Biomarker and Early Clinical Development

Statistical Methods in Biomarker and Early Clinical Development

Paperback

Medical ReferenceGeneral MathematicsGeneral Science

ISBN10: 3030315053
ISBN13: 9783030315054
Publisher: Springer Nature
Published: Jan 21 2021
Pages: 348
Weight: 1.12
Height: 0.75 Width: 6.14 Depth: 9.21
Language: English
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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